Mylan : Generic Version of Toprol-XL® Tablets

Dec. 16, 2011 - Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-release (ER) Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg. This product is the generic version of AstraZeneca's Toprol-XL® Tablets, which are indicated for the treatment of hypertension.

Metoprolol Succinate ER Tablets had U.S. sales of approximately $1.18 billion for the 12 months ending Sept. 30, 2011, according to IMS Health. Mylan's launch of this product is representative of the company's strength in continuing to bring difficult-to-formulate medicines to market.

Currently, Mylan has 166 ANDAs pending FDA approval representing $98.3 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health... Mylan's Press Release -

Philips : HeartStart FR3 automated external defibrillator for professional responders treating victims of sudden cardiac arrest

November 14, 2011 – Royal Philips Electronics (NYSE: PHG, AEX: PHI) introduced Philips HeartStart FR3 automated external defibrillator (AED) in the U.S. for professional responders who treat victims of sudden cardiac arrest (SCA). As the smallest and lightest professional-grade AED among leading global manufacturers, the HeartStart FR3 is Philips’ most advanced professional-grade AED. The rugged and reliable HeartStart FR3 is designed to help make lifesaving faster and easier for professional responders. The FR3 requires a prescription for use in the United States, and must be used under medical direction.

SCA is one of the leading causes of death in the United States, claiming nearly 300,000 lives each year. Defibrillation is recognized as the only definitive treatment for ventricular fibrillation, the abnormal heart rhythm most often associated with SCA. While cardiopulmonary resuscitation (CPR) may help prolong the window of survival, CPR alone cannot restore a normal cardiac rhythm. After 10 minutes without defibrillation, few attempts to resuscitate an SCA victim are successful.

Recognizing that time-to-therapy matters, the HeartStart FR3 significantly reduces deployment time by eliminating steps to help responders start delivery of the right therapy – CPR or defibrillation – on the patient faster. The FR3 automatically powers on when the Philips HeartStart FR3 carry case is opened1. The device also features easy to access, pre-connected peel and place pads that do not require opening a foil pouch. These unique features help speed therapy delivery... Royal Philips Electronics' Press Release -

RegeneRx : Notice of Allowance on Two Cardiac-Related Patent Applications

November 17, 2011 — RegeneRx Receives Notice of Allowance on Two Cardiac-Related Patent Applications -

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) announced that the Company has been notified that two cardiac-related patents will be allowed in Australia and Mexico.

The Australian patent is for the treatment or prevention of damage due to heart failure and will expire in July, 2026.

The Mexican patent is for the treatment or prevention of damage caused by increased blood flow in the myocardium, commonly called reperfusion injury. It will expire in January, 2026.

RegeneRx has similar patents pending in numerous other countries, including in the U.S., Asia and Europe... RegeneRx Biopharmaceuticals' Press Release -

STENTYS : Outstanding Interim Results of STENTYS International Clinical Study of 600 Heart Attack Patients

November 08, 2011 - PRINCETON, N.J. & PARIS - Lower rate of adverse events for STENTYS Self-Apposing™ Stent compared to reported results of conventional stents -

STENTYS S.A. (STNT.PA), a medical technology company commercializing the world's first and only Self-Apposing™ Stent to treat Acute Myocardial Infarction (AMI), disclosed today data on 600 patients from its ongoing “APPOSITION III” international clinical study who underwent an examination 30 day after treatment of a severe heart attack.

“With only 2.4% of patients experiencing a Major Adverse Cardiac Event (MACE) at 30 days in the latest patient cohort compared to rates of over 5% in published landmark trials with conventional stents, these remarkable preliminary clinical results could challenge the existing gold standard of treating AMI patients with balloon-expandable stents,” said study investigator Dr. Robert Jan van Geuns, M.D., Ph.D., Thorax Center at Erasmus Medical Center, Rotterdam, the Netherlands.

“We believe that these impressive clinical results confirm the Self-Apposing™ technology as the best solution for treating heart attack patients, and will contribute to increase its adoption in routine practice,” said Gonzague Issenmann, CEO and co-founder of STENTYS.

The STENTYS Self-Apposing™ Stent represents a major breakthrough: it solves the stent sizing dilemma that cardiologists are confronted with when treating heart attack patients with conventional stents. It “fits snugly” into the contour of a blood vessel, and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase, avoiding a major complication of all other conventional stents: malapposition... [PDF] STENTYS' Press Release -

Emboline : to Debut Game-Changing Embolic Protection Technology for Percutaneous Heart Valve Procedures in San Francisco Next Week

November 02, 2011 - Emboline CAP™: new approach to eliminating aortic embolic risk, providing Complete Accessible Protection™ from cardiac procedural-related emboli -

Emboline, Inc., an emerging medical device company, will debut its game-changing embolic protection devices for percutaneous heart valve repair and replacement in San Francisco next week.

The Company is initially focused on developing its novel Emboline CAP™ device; a next-generation system intended to provide complete protection of the arterial bed (both the cerebrals and the aortic lumen) utilizing a uniquely ported design that maintains tool access through the filter.

In addition, Emboline is also developing Emboliner™, a simple-to-use, low profile system for protection of the cerebral vessels alone... [PDF] Emboline's Press Release -

SORIN GROUP INVESTS IN ENOPACE BIOMEDICAL

October 17, 2011 - SORIN GROUP INVESTS IN ENOPACE BIOMEDICAL, EARLY STAGE COMPANY FOCUSED ON INNOVATIVE SOLUTION FOR HEART FAILURE PATIENTS -


Investment will drive development of a unique interventional technology for the largest unmet clinical need in the cardiovascular field –

Sorin Group (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced a minority investment in Enopace Biomedical, an early-stage company focused on the development of a neuromodulation system to treat patients with congestive heart failure.

Enopace’s technology consists of a minimally invasive, implantable neurostimulator for heart failure patients that increases cardiac efficiency by reducing left ventricular workload. Sorin’s $7 million investment will finance the initial clinical studies of this technology as well as ongoing product development. Sorin Group joins Rainbow Medical as an investor in Enopace.

Heart failure is the largest unmet clinical need, with the highest associated healthcare costs, in the cardiovascular world today. In Europe and in the United States around 15 million patients suffer from chronic heart failure. The United States healthcare system spends over $40 billion to treat these patients. CRT (cardiac resynchronization therapy) devices currently address part of the systolic heart failure population, but no approved therapies exist for diastolic patients. Neuromodulation systems represent a significant opportunity to expand the clinical indications for device-based heart failure therapy and, moreover, enhance the treatment for congestive heart failure patients... Sorin's Press Release -

Symetis : ACURATE TA(TM) Aortic Bioprosthesis Receives CE Mark Certification on Sept. 30th 2011

10/03/11 - Symetis SA, a private Swiss company developing new transcatheter aortic valve implantation (TAVI) systems, announced during the Techno-College at the EACTS (European Association for Cardio-Thoracic Surgery) meeting in Lisbon that it received CE Mark approval for its ACURATE TA™ transapical TAVI system. The approval of this 2nd generation TAVI device, used to treat elderly patients with severe aortic stenosis (AS) for whom open surgical repair is considered to be high risk, opens the company to a market estimated to exceed $2 billion by 2014.

CE Mark approval: 

Symetis performed two clinical trials of the ACURATE TA™ in Germany: a FIM trial (n=40) and a Pilot study (n=50). The CE Mark was granted by the National Standards Authority of Ireland (NSAI, www.nsai.ie) using a composite of patients from both studies, including 65 patients followed at 30 days, 30 patients at 6 months and 10 patients at 1 year. The completion of enrolment in both studies translates to Symetis ACURATE TA™ having the largest clinical experience to date of any 2nd Generation TAVI device in clinical trials or approved for market. In addition, this dataset establishes a new standard for the approval of future 2nd generation TAVI systems.

Clinical experience: 

Both studies were single-arm, prospective, multicenter trials that enrolled high-risk patients with severe AS. The combined patient cohort consists of 90 patients enrolled at six investigation centers in Germany between November 2009 and July 2011. The primary endpoint of both studies is 30-day mortality. Primary endpoints included procedure success (95%) and safety/performance data collected at 30 days, 6 months and 1 year. The secondary endpoints are MACCE, as well as ECHO parameters evaluating performance of the ACURATE TA™... [PDF] Symetis' Press Release -

Alere : HABIT Study Shows That Home BNP Testing May Allow for Earlier Interventions & Facilitate Better Management of Heart Failure Patients

Oct. 4, 2011 -- At the Heart Failure Society of America's 15th Annual Scientific Meeting, Alan Maisel, M.D., VA San Diego Healthcare System, announced that B-type natriuretic peptide (BNP) may have utility in monitoring heart failure patients for early warning signs of decompensation in advance of acute presentations. HABIT, a multi-center study led by Maisel and sponsored by Alere Inc., is the first of its kind to have heart failure patients measure their BNP levels from home every day. 187 subjects were enrolled in the study following hospital discharge for a heart-failure-related event, and BNP levels were measured daily for 60 days using a fingerstick test run on the Alere™ Heart Check System. The results of the study demonstrate that BNP levels fluctuate rapidly and frequently in heart failure patients. They also provide insight into new strategies for monitoring these fluctuations, which in turn might lead to the early identification of problems in these patients. "The results of the HABIT study provide an important advancement in our knowledge about B-type natriuretic peptide in heart failure," said Maisel. "For the first time, we have seen that, in a population of patients discharged with heart failure, natriuretic peptides can rapidly and significantly change from day to day over the course of weeks, illustrating that frequent measurement could be useful in the accurate assessment of heart failure patient status." BNP is secreted by the heart's ventricles in response to changes in pressure that occur when heart failure develops or worsens. As the symptoms of heart failure become more severe, the level of BNP in the blood increases. For this reason, routine monitoring of BNP levels in outpatient and home settings may be a viable tool for identifying decompensation events earlier and managing them more effectively. The results of HABIT appear to support this conclusion. "The routine availability of BNP values in established heart failure patients could provide us with the first direct and objective indicator of the heart's response to change in a patient's condition," stated Maisel. "BNP could become an important monitoring tool for use in the homes of patients to manage the disease remotely, thereby identifying decompensation earlier to reduce healthcare costs and downstream re-hospitalizations."... [PDF] Alere's Press Release -

Sunshine Heart Completes AU Portion of Placement

05 September 2011 - Two-part financing strategy supporting C-Pulse® Heart Assist System - Sunshine Heart, Inc. (ASX: SHC), announced it has entered into definitive agreements with institutional and high net worth investors to sell approximately 55.8 million shares of common stock in a private placement totaling $2.2 million. This completes the Australasian portion of the Company’s financing plan, as previously announced and approved by shareholders at its General Meeting on July 18, 2011. Proceeds from the placement will be used to support the U.S. pivotal trial and the continued development of the C-Pulse® Heart Assist System.

Terms of the placement are identical to the first tranche, which closed on July 27, 2011. Investors also receive warrants to purchase 3 shares of common stock for every ten shares purchased, at an exercise price of $0.056 per share (4-year term). RBS Morgans was the exclusive Australian placement agent for the transaction.

“As we progress to our next important stage of development, we are expanding our investor base in North America. Australasian investors have been included in the placement on the same terms and conditions. The Board and the management team very much appreciate the continuing support from our long-standing shareholders who participated in this financing, including our largest shareholder, CM Capital. We are very encouraged by the quality of new investors joining the registry. This is an exciting time for Sunshine Heart, and this financing is an essential part of our accelerating development,” said Dave Rosa, Sunshine Heart’s Chief Executive Officer.

The Company has shareholder approval to issue up to an additional 170.6 million shares on the same terms until September 16, 2011, the cut-off date agreed with participants in the first tranche of the placement. Thus far, $6.8 million has been raised.

About the C-Pulse Heart Assist System

C-Pulse Heart Assist System utilizes an extra-aortic approach to proven intra-aortic balloon counter pulsation technology to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Operating outside the patient’s bloodstream, the novel extra-aortic approach of the C-Pulse technology offers greater flexibility allowing patients to disconnect as necessary or desired... [PDF] Sunshine Heart's Press Release -

MAQUET Cardiovascular : FDA 510(k) Clearance and CE Mark for Its New SENSATION PLUS™ Intra-Aortic Balloon Catheter

Sept. 20, 2011 -- MAQUET Cardiovascular, a leading provider of cardiovascular technologies, announced today that it has received both 510(k) clearance from the U.S. Food & Drug Administration (FDA) and CE mark approval from the British Standards Institution (BSi) for its new SENSATION PLUS™ 50cc 8 Fr. intra-aortic balloon catheter. The new SENSATION PLUS intra-aortic balloon (IAB) catheter is the first 50cc 8 Fr. IAB catheter to combine fiber optic signal acquisition with greater hemodynamic support compared to a standard 40cc IAB catheter.

"Clinicians have been asking for an IAB that combines all of the benefits of fiber optic technology; faster initiation of therapy, easier patient management and a crisp, clean arterial pressure wave form with increased hemodynamic support," said Deb Joseph, Vice President, Marketing and Clinical Services. "We believe that the new, state-of-the art SENSATION PLUS™ intra-aortic balloon catheter meets these needs and will enable clinicians to provide patients with improved care."

The new 50cc 8Fr. SENSATION PLUS IAB catheter provides greater patient support, comfort and ease of use than any IAB catheter MAQUET has ever offered. SENSATION PLUS incorporates fiber optic signal acquisition and provides 25 percent more blood volume displacement than standard 40cc IAB catheters, allowing for improved unloading and better augmentation. This new IAB catheter also comes with two Stat Lock® IAB stabilization devices which allow the catheter to be secured to the patient's leg without sutures. This is more comfortable for patients and eliminates the risk of suture needle sticks for clinicians when initiating counterpulsation support. The new IAB catheter will be available for sale in October... [PDF] MAQUET's Press Release -

Ono Pharmaceutical : License Agreement with Servier for Ivabradine

September 14, 2011 - Ono Pharmaceutical Co., Ltd. (Osaka, Japan) announced that it has entered into a license agreement with LES LABORATOIRES SERVIER (Suresnes, France) to exclusively develop and commercialize in Japan Ivabradine (generic name) which is on the overseas market* for the treatment of stable angina and currently under review by European Medicines Agency (EMA) of marketing approval application for the additional indication of chronic heart failure (CHF). Ono will pay to Servier 20 million euros as an upfront payment of the agreement and thereafter milestone payments based on development stage. In addition, Ono will also pay sales-based milestone payments upon achievement of projected sales.

In CHF, heart cannot pump out enough blood to satisfy oxygen requirement in major organs due to decreased cardiac function. That leads to congestion in lungs or systemic venous which cause various systemic symptoms including dyspnea and sense of exhaustion and daily lives of patients are therefore impaired. It is known that life prognosis of CHF patients are very poor and also that, while higher heart ratemay be increased in order to compensate for low cardiac output, this increase is detrimental in the long term. In fact, it is reported that higher heart rate has been associated with poor prognosis... [PDF] Ono Pharmaceutical's Press Release -

Advanced Circulatory Systems : NIH-Funded Study Demonstrates That Patients Receiving New CPR Devices (ResQPOD and ResQPUMP) and Cooling Have Improved Long-Term Brain Function Following Cardiac Arrest

Sept. 6, 2011 - Advanced Circulatory Systems Inc. (ACSI) announced results from a large, NIH-funded clinical trial comparing standard cardiopulmonary resuscitation (CPR) to a new method of CPR that provides greater protection to the heart and brain when the heart stops beating (cardiac arrest).

Their new device combination, called the ResQCPR™ System, combines an active compression decompression CPR (ACD-CPR) device, called the ResQPump™, and an impedance threshold device (ITD), called the ResQPOD®.

Additional results from the ResQTrial study have now demonstrated that when the ResQCPR System was used together with therapeutic hypothermia, there was a six-fold increase in the percentage of patients who improved from poor neurologic function at hospital discharge to good neurologic function at 90 days, when compared to standard CPR with hypothermia.

"The striking improvement in patients treated with the ResQCPR System and hypothermia demonstrates the important synergy between the two technologies. These findings provide a new way to significantly decrease the number of patients with poor long-term neurological function, especially when the ResQCPR System is applied early during cardiac arrest," ... [PDF] Advanced Circulatory Systems' Press Release -

nContact : CE Mark Approval of its Generation 4 "EPi-Sense(TM)" Epicardial Ablation System

August 18, 2011 - First Multi-disciplinary, All-in-One Tool that Enables Epicardial Ablation, Mapping and Navigation for the Treatment of Cardiac Arrhythmias - nContact, Inc. (nContact), the leading innovator in epicardial ablation devices and techniques, announces it has received CE Mark approval for the "EPi-Sense(TM) Guided Coagulation Device with VisiTrax®" for the treatment of cardiac arrhythmias, including atrial fibrillation. The EPi-Sense features first-of-its kind epicardial sensing electrodes designed to allow both electrophysiologists (EP) and cardiothoracic surgeons to map and navigate the epicardium and locate areas for linear epicardial ablation. John Funkhouser, CEO, nContact, Inc., said, "The CE Mark approval of the EPi-Sense System, our 4th generation of coagulation devices, marks yet another milestone in our commitment to improve and evolve epicardial ablation tools and techniques for better access to the heart. Our goal is to create a new standard of care for treating cardiac arrhythmias. We believe epicardial ablation is critical to better clinical outcomes, and the new 'hybrid' device is designed for use by both EPs and surgeons." EPi-Sense further enhances the advantages of the Convergent Procedure, a closed chest, endoscopic technique enabled by nContact's Numeris® Coagulation System with Visitrax®. The primary procedure advantages include visible access to the posterior of the atrium through a trans-diaphragmatic pericardial window (eliminating the need for chest incisions, ports, lung deflation or heart dissections), and the ability to create visible, non-conductive, linear lesions on a beating heart. With the new EPi-Sense device, EP mapping systems can locate the EPi-Sense ablation device in real time... [PDF] nContact's Press Release -

ZOLL Medical : Dutch Kijlstra Ambulance BV Equips Entire Fleet With Autopulse Non-invasive Cardiac Support Pump

August 17, 2011 ─ ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced that Kijlstra Ambulance BV, the largest emergency service in the Friesland province of the Netherlands, has purchased 22 AutoPulse® Non-invasive Cardiac Support Pumps to equip its entire fleet of emergency vehicles with the automated chest compression device. Kijlstra is already using the AutoPulse on its two rapid responder vehicles for cardiac arrest and resuscitation.

Erwin de Vos, Kijlstra Project Coordinator, recommended the purchase to senior management after observing that the uninterrupted, high-quality chest compressions provided by the AutoPulse could not be delivered consistently by manual compressions alone. “In our experience, the force and complete thorax compression the AutoPulse administers is superior to manual CPR. The AutoPulse moves more blood more effectively than manual chest compressions, thereby providing the best possible patient care.”

Prior to selecting the AutoPulse, a market research team lead by Edward Jona, MD, Medical Manager of Kijlstra, evaluated the AutoPulse against another automated CPR compression device. The team determined that, in addition to the AutoPulse’s ability to maintain myocardial and cerebral perfusion, it offered a high level of safety for both the patient and paramedic, indicating the device’s effectiveness in keeping both patients and rescuers safe in the back of a moving ambulance... ZOLL Medical's Press Release -

Thoratec: Acquisition of Medical Business of Levitronix

Aug. 3, 2011 - Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, announced that it has acquired the medical business of Levitronix LLC ("Levitronix Medical") for an upfront cash payment of $110 million, as well as potential future cash earnout payments of up to $40 million. This transaction solidifies Thoratec's position as the leading, full-line provider of mechanical circulatory support products for both acute and chronic needs, advancing the company's mission of delivering superior therapies to a broad population of heart failure patients.

The acquisition of Levitronix Medical follows a successful strategic partnership between the two companies. Since 2006, Thoratec has provided distribution and clinical support in the U.S. for the CentriMag® Acute Circulatory Support System, Levitronix Medical's flagship product, under an agreement that was scheduled to expire at the end of 2011. Levitronix Medical and Thoratec have also collaborated on the development of the fully magnetically levitated motor technology employed in the HeartMate® III left ventricular assist system, which is currently in preclinical testing... Thoratec's Press Release -

Rosetta Genomics : Preliminary Data on Discovery of Blood-Based microRNA Signature for Identification and Stratification of Heart Failure Patients

07/26/11 - Rosetta Genomics (NASDAQ: ROSGD), a leading developer and provider of microRNA-based molecular diagnostic tests, announced preliminary data from a study it conducted in order to identify a microRNA signature in blood for congestive heart failure (HF) syndrome and to assess the feasibility to develop a minimally-invasive, microRNA-based stratification test for HF.

Demographic and clinical status of HF patients in combination with indices of cardiac and renal function can identify a large proportion of high risk patients, however, risk stratification based on these factors alone remains imprecise, with some high risk patients not recognized and others inappropriately marked as high risk. Early identification of patients at higher risk for adverse events could lead to earlier intervention that could potentially improve outcomes... Rosetta Genomics' Press Release -

Berlin Heart : FDA Advisory Panel Unanimously Recommends Approval of EXCOR® Pediatric Ventricular Assist Device For Use In The United States

Tuesday July 26, 2011 - At the request of Dr. Bram Zuckerman, Director, Division of Cardiovascular Devices, Center for Devices and Radiologic Health of the United States Food and Drug Administration, a special panel was convened on Thursday July 21 in Gaithersburg, Maryland to review the results of the EXCOR® IDE clinical trial.
The specific charge of the panel was to review the clinical data from the trial and to make recommendations to the FDA concerning the safety and probable benefit of the EXCOR® VAD as it pertains to an application for Humanitarian Device Exemption (HDE) approval. This 22 member panel was comprised of a group of experts in pediatric and adult cardiology, pediatric and adult cardiac surgery, neurology, biostatistics, and other areas of expertise. It also included patient, consumer, and industry representatives. The panel was chaired by Dr. Clyde Yancy, Chief of the Division of Cardiology at Northwestern University School of Medicine in Chicago, Illinois.

In preparation for presenting the study results to the panel, a team representing Berlin Heart and the investigation was assembled. Working together over several months, including several face to face meetings, this group, now affectionately termed the Berlin Heart “Dream Team”, worked very hard to be well prepared... [PDF] Berlin Heart's Press Release -

Biosense Webster : First Patient In Groundbreaking SMART-AF Trial And Completes First Atrial Fibrillation Ablation Case In The United States

July 14th, 2011 – Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the enrollment of the first patient in their latest groundbreaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study, and the treatment of the first patient with the new ThermoCool® SmartTouch™ Contact Force Sensing Catheter and Software Module in the United States.

The SMART-AF study is designed to demonstrate the safety and effectiveness of ThermoCool® SmartTouch™, the latest addition to the market-leading and FDA approved NaviStar® ThermoCool® Catheter family, in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation. SMART-AF expects to enroll up to 164 patients in leading centers across the United States.

The ThermoCool® SmartTouch™ Catheter is one of the most advanced catheters developed by Biosense Webster to date. During cardiac ablation procedures, the ThermoCool® SmartTouch™ Catheter enables the measurement of catheter tip contact force and direction inside the heart. This information is graphically displayed on the CARTO® 3 Mapping and Navigation System, the most advanced 3D Mapping System available on the market today, via the novel Carto® 3 Smarttouch™ Module, to create a fully integrated solution combining contact force and 3D mapping and navigation capabilities... Johnson and Johnson's Press Release -

Pegasus : U.S. PATENT FOR ITS HEARTVUE 6S SCREENING DEVICE; TWO EUROPEAN DISTRIBUTORS.

April 19th, 2011 - Pegasus/HeartView LLC, (Symbol: PGUZ-OTC), announced that they have acquired a U.S. Patent Number #US 7,519,416, titled "Diagnostic Method Utilizing Standard Lead ECG Signals" for its HeartVue 6S Screening Device.

This development will now initiate procedures to acquire FDA approval prior to marketing efforts of the system in the United States. The HeartVue 6S System is an advanced technology that analyzes low amplitude ECG oscillations (ECG dispersion mapping) and reports them as myocardial micro-alternation indexes (MMI). The HeartVue 6S System provides a non-invasive assessment of heart disease in 30 seconds, utilizing only 4 limb electrodes. The results are then presented as a color-coded, three dimensional digital heart map, which reflects electrical dispersions.

After acquiring a CE Mark Approval for the marketing of the 6S Screening Device in Europe, the Company has now subsequently appointed two distributors to roll out marketing/sales efforts in their respective territories... [PDF] Pegasus' Press Release -

Sahajanand Medical Technologies : CE mark on Two Sirolimus Eluting Coronary Stents

June 26, 2011. Surat, India - Sahajanand Medical Technologies (SMT) announced that it has received European CE marking for two Sirolimus eluting coronary stent systems; Supralimus® (Sirolimus eluting stents on stainless steel platform) & Supralimus-Core® (Sirolimus eluting stent on chromium cobalt platform).
The CE approval for Supralimus® and Supralimus-Core® brings the company the distinction of being the first in the world to have CE approval for both Sirolimus and Paclitaxel -eluting coronary stents and in total three CE approved drug eluting stents.

“The CE mark for Supralimus® and Supralimus-Core® is a significant accomplishment that substantiates our product’s excellent clinical outcomes. This further confirms our commitment to providing patients and clinicians new treatment options for coronary artery disease.” shared Dhirajlal Kotadia-CEO of Sahajanand, “The excellent flexibility, highly deliverable system and proven safety and efficacy of Sirolimus with the biodegradable polymers make our stents an excellent choice for a variety of patients” he added... [PDF] Sahajanand Medical Technologies -

BIOTRONIK launches Lumax 540 VR-T DX, the world’s only singlechamber ICD with complete atrial diagnostics

June 24, 2011 - A novel solution for optimizing sensor-based diagnostics for patients with cardiac disease - BIOTRONIK SE & Co. KG, a worldwide leader in manufacturing cardiac medical devices, announced that the innovative new Lumax 540 VR-T DX single-chamber implantable cardiac defibrillator (ICD) and Linoxsmart S DX cardiac lead system will be launched this coming week at the EHRA EUROPACE electrophysiology congress in Madrid, Spain. The Lumax DX system uniquely expands the diagnostic capabilities of the standard single-chamber ICD by integrating special atrial sensors and advanced discrimination algorithms.

The Lumax DX serves a previously unmet need for cardiac device patients who are candidates for a single-chamber ICD. Standard single-chamber ICDs are designed only to sense changes in ventricular rhythm and are unable to correctly sense atrial arrhythmias such as atrial fibrillation (AF) correctly, which increases the risk of inappropriate shock or could potentially result in the patient having a stroke.

“Studies have demonstrated that the lifetime risk of developing AF is 25% in people who have reached the age of 40. Furthermore, out of all ICD and pacemaker patients, it has been shown that more than 13% have a previously unknown AF... [PDF] BIOTRONIK 's Press Release -

GE Healthcare and ImaginAb : Master Research Agreement for Imaging with Antibody Fragments

June 5, 2011 — GE Healthcare Ltd. and ImaginAb, Inc. have executed a master research agreement around the development of new PET (Positron Emission Tomography) diagnostic imaging agents based on ImaginAb’s antibody fragment technology. The agreement is launched with an initial exclusive collaboration around a novel cardiovascular target*.

“We are very pleased to have established this collaboration with GE and particularly delighted that our first project extends ImaginAb’s reach into the rapidly growing market for new PET tracers to image high-risk cardiovascular disease,” said Dr. Christian Behrenbruch, CEO of ImaginAb. “As a development partner, GE Healthcare brings tremendous and much-valued expertise in radiochemistry process development and clinical translation.”


“With the growing importance of biologics-based therapeutics in treating cancer and inflammation and our evolving understanding that cancer and cardiovascular disease are modulated by fundamental immune processes, we view this collaboration with ImaginAb as timely”, said Marivi Mendizabal, Head of Research, GE Healthcare, Medical Diagnostics. “Our vision is that technologies, such as the ImaginAb antibody fragment platform, will enable us to rapidly develop new targeted molecular diagnostics – not just for our own clinical portfolio, but as a ‘companion’ diagnostic offering to antibody/drug conjugat pipelines for our strategic biopharma partnerships”... ImaginAb's Press Release -

NeuroVive Pharmaceutical : First Heart Attack Patient Treated in European Cardioprotection Phase III trial with NeuroVive’s CicloMulsion

April 19, 2011 - Investigator-initiated European multicenter trial of 1,000 acute heart attack patients will examine the ability of cyclosporine to protect cardiac tissue — NeuroVive Pharmaceutical and Hospices Civils de Lyon (HCL) announced the enrollment and treatment of the first patient in the European multicenter trial of myocardial infarction (the CIRCUS study). NeuroVive’s advanced CicloMulsion™ cremophor-free IV cyclosporine formulation is used in this study of 1,000 patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction to examine cyclosporine’s ability to protect cardiac tissue. The double-blind, placebo-controlled, investigator-initiated study is being led by trial sponsor Professor Michel Ovize, MD, PhD, of HCL. NeuroVive is supporting the study by providing active drug, placebo and drug logistics. The study will enroll patients at 40 centers in France and additional European sites.

Professor Michel Ovize comments:
"Patients with myocardial infarction often undergo emergency percutaneous coronary intervention in which a catheter passed through the major blood vessels restores blood flow to blocked coronary arteries. Even after blood flow is restored, damage to the heart muscle continues to progress through what is known as reperfusion injury. Small-size proof-of-concept studies have shown that reperfusion injury may account for as much as 30-40% of total infarction-related myocardial damage and that timely therapeutic interventions can prevent this damage (Staat et al. Circulation 2005; Thibault et al. Circulation 2008). From a clinical point of view, it is critical to develop a drug to protect cardiac tissue during PCI and hopefully improve clinical outcome.”... NeuroVive Pharmaceutical's Press Release -

Cytori Therapeutics : Sustained Benefits at 18 Months in Cardiac Cell Therapy Heart Attack Trial

06/08/11 -- Cytori Therapeutics (NASDAQ: CYTX) is reporting 18 month outcomes from its APOLLO trial for Acute Myocardial Infarction (AMI). The results from the 14 patient, randomized, placebo-controlled, double-blind safety and feasibility trial in patients with ST-elevation AMI demonstrated the following:

• Mean reduction in infarct size at 6 months was preserved at 18 months for the cell treated group (standard-of-care plus cells), at 11.7% and 11.2%, respectively. In contrast, patients receiving control (standard-of-care plus placebo), exhibited diminished treatment effect from 6 months (6.1%) to 18 months (4.4%) (see Fig. 1);

• The mean reduction in left ventricular infarct size (reduction in the portion of the heart damaged by the heart attack) was statistically significant (p < 0.05) from baseline to 18 months in the cell-treated group. In patients receiving control, there was less improvement which was not statistically significant;

• Statistically significant (p < 0.05) improvement in perfusion of the left ventricle (blood flow through the tissue of the heart) from baseline to 18 months was observed in the cell-treated group. In patients receiving control treatment, there was less improvement which was not statistically significant; and

• There were substantially fewer premature ventricular beats (PVBs) per holter recording in patients who had received cells compared to those who had received control (mean of 24 and 146 PVBs per recording, respectively)... Cytori Therapeutics' Press Release -

Terumo launches its drug-eluting stent, "Nobori," in Japan

May 16, 2011 - Terumo Corporation (Head Office: Shibuya-ku Tokyo; President: Yutaro Shintaku) announced the start of sale of its "Nobori" Drug-Eluting Coronary Stent (DES) in Japan from May.

The product is the first made-in-Japan DES which received approval for its manufacture and sale, based on the clinical trials conducted in Japan.

"Nobori" is the only product in Japan that employs bioresorbable polymer as its drug coating material. In addition, polymer and drug are applied only to the surface to contact vessel tissues.

Terumo Corporation received CE certificate*1 for the commercial sale of the "Nobori" in Europe, in January 2008. It is currently sold in more than 20 countries in Europe, Asia (excluding Japan) and Latin America... Terumo's Press Release -

Physio-Control : New Hospital Solutions for the LIFEPAK 15 Monitor/Defibrillator

May 3, 2011 - New Feature Set Includes External AC/DC Power and Temperature Monitoring for Therapeutic Hypothermia Patients – Physio-Control, Inc., a global leader in emergency medical solutions and wholly‐owned subsidiary of Medtronic, Inc. (NYSE: MDT), announced availability of new solutions for the LIFEPAK® 15 monitor/defibrillator designed to help hospital, as well as pre-hospital, teams provide more effective patient care. The 15, when used together with CODE-STAT™ data review software and the LIFENET® System data network, empowers hospital and pre-hospital care teams with a powerful new suite of tools that utilize patient, performance and device data to improve care, trim operational costs and streamline equipment management.

The new solutions strengthen the 15’s position as the most clinically- and operationally-advanced monitor/defibrillator available for emergency medical teams, and include :

• External AC/DC power – Ideal for hospital use or in emergency medical services (EMS) vehicles with AC power. The external power adapter charges the batteries while connected to AC or DC power, providing up to 6 hours of battery run time, and features a break-away connector allowing for immediate portability. New on-screen indicators display external power status and battery charging state.
• Continuous temperature monitoring – Allows clinicians to continuously monitor temperature for therapeutic hypothermia and other critical patients. Patient temperature data can be displayed, saved and transmitted with other monitoring parameters and trended during post-event review with CODE-STAT.
• Continuous waveform capture and storage – Saves waveform data from all three channels (ECG, SpO2, CO2), allowing for more complete post-event review in CODE-STAT. Clinicians can now correlate capnography waveforms with changes in a patient’s status. Additionally, STJ values are now included on the 12-lead ECG printout to help clinicians identify critical changes.
• Automated self-reporting capabilities – Important device information such as device readiness, usage data and battery information can be combined with LIFENET® Asset to provide customers with a new level of insight into their device readiness, simplifying management of setup options and allowing customers to perform their own device software updates.

“The LIFEPAK 15 monitor was designed as a platform that allows for continuous innovation. These hospital solutions for the 15 add new clinical capabilities, providing clinicians with the broadest selection of monitoring options available,” said Brian Webster, president, Physio-Control, Inc. “With therapeutic hypothermia treatment for cardiac arrest patients already commonplace in hospitals and increasing in EMS use, we expect the new continuous temperature monitoring to be adopted rapidly by customers.”... Physio-Control's Press Release -

CardioDx : Ability of Corus CAD to Identify Obstructive Coronary Artery Disease and Add Independent Information to Coronary Calcium Scoring by CT...

April 5, 2011 - New Multi-center Trial Results Demonstrate Ability of Corus CAD to Identify Obstructive Coronary Artery Disease and Add Independent Information to Coronary Calcium Scoring by CT Angiography - Results Presented at American College of Cardiology’s Scientific Sessions – CardioDx, a pioneer in the field of cardiovascular genomic diagnostics, announced that data presented at the American College of Cardiology’s 60th Annual Scientific Sessions demonstrate the ability of Corus™ CAD, a blood-based gene expression test, to identify obstructive coronary stenosis while adding independent information to coronary calcium scoring in patients undergoing CT angiography. In this study, the negative predictive value of Corus CAD for identifying obstructive coronary artery disease as assessed by CT angiography exceeded 95%.

“The results of this independent cohort provide new support for the high negative predictive value of the Corus CAD test in the identification of obstructive coronary artery disease in stable patients being noninvasively assessed,” said Szilard Voros, M.D., of The Piedmont Heart Institute Physicians group in Atlanta, the investigator who presented the results. “The ability of gene expression testing to provide independent information to a noninvasive imaging modality like coronary calcium scoring can empower more comprehensive decision-making about patient management.”... CardioDx's Press Release -

Nile Therapeutics : Fast Track Designation for Cenderitide for Post-Acute Indication

March 31, 2011 -- Nile Therapeutics, Inc. (NASDAQ: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Nile's post-acute development program for cenderitide, which has the goal of reducing cardiovascular mortality and cardiovascular re-hospitalization in the post-acute period in patients with acute decompensated heart failure.

As previously announced, Nile plans to develop cenderitide as an outpatient therapy to be delivered to acutely decompensated heart failure (ADHF) patients continuously for up to 90 days after discharge from the hospital. This is a novel therapeutic indication that is being referred to as "post-acute."

"We are very pleased that the FDA has recognized cenderitide's potential to address an important unmet medical need for heart failure patients," said Joshua Kazam, Nile's Chief Executive Officer. "If our post-acute cenderitide program is successful, then we may be able to reduce the annual number of hospital visits for ADHF, potentially saving the health care system billions of dollars."... Nile Therapeutics' Press Release -

Stealth Peptides : Results from Healthy Volunteers Phase I Clinical Study with Bendavia™

April 4, 2011 – Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative therapies, announced the results of a healthy volunteers Phase I clinical study of Bendavia™, a novel compound that targets the mitochondrion to treat ischemia reperfusion injury. This study evaluated healthy male and female volunteers representing a broad range of adult ages. During the study, volunteers received a single dose of Bendavia administered as an intravenous infusion over an extended period. Safety data from the clinical trial and preliminary results demonstrate that Bendavia appears to be safe and well–tolerated at the dose evaluated, with no serious adverse events reported. Pharmacokinetic analysis from related clinical studies also showed highly predictable dose–proportional exposure of Bendavia among volunteers.

The initial clinical program for Bendavia is the treatment of ischemia reperfusion injury, a common complication of interventional procedures for acute myocardial infarction (AMI) and coronary bypass surgery. Standard animal models for AMI demonstrate Bendavia’s beneficial myocardial effects and confirm the significance of its novel mechanism of action, which preserves mitochondrial function under pathological conditions, for ischemia reperfusion injury.

Contrary to prior therapeutic strategies for ischemia reperfusion injury and AMI that focused on uni–targeted pathways, Bendavia and its mitochondrial directed actions address the more complicated, multifactorial nature of diseases. Specifically, Bendavia has been shown to improve electron transport efficiency, maintain mitochondrial respiration and adenosine triphosphate levels and prevent mitochondrial swelling and depolarization. Bendavia also appears to be a strong neurologic protectant, which holds promise as a treatment for cardiac arrest and stroke patients... Stealth Peptides' Press Release -

Critical Diagnostics : ST2 Predicts Outcomes and Cardiac Function After Chest Pain and Myocardial Infarction and in Advanced Heart Failure

April 1, 2011 - Three Clinical Studies at the American College of Cardiology Examine the Presage® ST2 Assay Across Clinical Presentations and Progression to Advanced Cardiovascular Disease - A novel cardiac biomarker, ST2, will be highlighted in three presentations at the American College of Cardiology (ACC) in New Orleans this week. These studies and others have demonstrated that a patient's ST2 level can help a physician better predict prognosis, change in cardiac status, and development of cardiovascular complications such as heart failure, at critical clinical decision points, including at initial presentation with chest pain, after recovery from myocardial infarction, and in the cardiac intensive care unit.

"We continue to find that ST2 is a valuable prognostic tool in assessing patients across various stages of cardiovascular disease," said Dr. James L. Januzzi, the Director of the Cardiac Intensive Care Unit at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School. "In our recent study in Advanced Stage Heart Failure Patients, we concluded that measurement of ST2 may help us determine appropriate courses of action in these late-stage patients."...

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..."We are pleased to see the research community continue to generate strong evidence that ST2 predicts outcomes for cardiovascular patients," said James Snider, President of Critical Diagnostics. "The studies presented here show that ST2 can be a valuable tool for clinicians across the spectrum of heart failure: from predicting onset to predicting outcomes in late-stage patients. These clinical data continue to build evidence that ST2 may help aid physicians in clinical decision-making."... Critical Diagnostics' Press Release -

Lilly : Effient® Added to Updated ACCF/AHA Clinical Guidelines for ACS-PCI Patients with Unstable Angina and Non-ST Segment Myocardial Infarction

March 29, 2011 - Lilly - Oral antiplatelet therapy Effient® (prasugrel) has been added to the updated clinical practice guidelines as a Class I recommended treatment option for patients undergoing percutaneous coronary intervention (PCI) after experiencing heart-related chest pain at rest (unstable angina) or non-ST segment elevation myocardial infarction (NSTEMI). NSTEMI is a type of heart attack that that does not need to be treated with emergent opening of a blocked coronary artery. The update to the clinical guidelines, jointly developed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA), was published online on March 28, 2011, in the Journal of the American College of Cardiology and Circulation.

"Class I" means that a given "procedure/treatment should be performed/administered" to patients, given it was found to be "useful/effective/beneficial." Class I is the highest recommendation provided by the guidelines committee.

Effient tablets are approved by the U.S. Food and Drug Administration to reduce the risk of future heart-related events, such as heart attack or stent thrombosis, in patients with acute coronary syndromes (ACS) who are treated with PCI. ACS includes heart attack and unstable angina (UA)... Eli Lilly and Company's Press Release -

Cerenis : Phase 2 Study of Lead Product Candidate, CER-001, in Patients with Acute Coronary Syndrome »

March 15, 2011 - Cerenis Therapeutics, a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and metabolic diseases, announced the start of the Phase 2 CHI-SQUARE (Can HDL Infusions Significantly Quicken Atherosclerosis Regression?) study of CER-001 in patients with acute coronary syndrome (ACS).

CER-001 is an innovative complex of recombinant human ApoA-I, the major structural protein of HDL, and phospholipids. It has been designed to mimic the structure and function of natural, nascent HDL, also known as pre-beta HDL, which is believed to be protective against atherosclerosis. It is hoped that CER-001 will further reduce cardiovascular events in high-risk patients by promoting removal of cholesterol from the vessel wall.

The double-blind, randomized, placebo-controlled, safety and efficacy study will assess the ability of CER-001 to regress coronary atherosclerotic plaque as measured by intravascular ultrasound (IVUS). The study will include over 500 patients at 50 centers in the US, Canada and Europe, and will evaluate three different dose levels given in six weekly intravenous infusions... Cerenis Therapeutics' Press Release -

AtCor Medical : US$0.6 million new pharmaceutical contract

8 March 2011 - AtCor Medical (ASX: ACG), the developer and marketer of the SphygmoCor® system, which measures central blood pressures and arterial stiffness noninvasively, announced that it has signed a new US$0.6 million agreement to supply SphygmoCor systems and clinical trial support services to a major international pharmaceutical company.

Duncan Ross, CEO of AtCor Medical said, “AtCor has converted another contract due to the strength of both SphygmoCor technology and our clinical trial applications and data management services in pharmaceutical trials. We are especially pleased that the assessment of central pressures and arterial stiffness continues to grow beyond hypertension therapies, such as this study, and across disease states as drug companies endeavor to fully characterize the clinical benefits of new and existing drug therapies”. Mr Ross continued “over the past five years there has been mounting evidence of both positive and detrimental effects on central pressures and arterial stiffness in a number of drug classes which has captured the attention of both regulators and the pharmaceutical industry.”... [PDF] AtCor Medical's Press Release -

Novartis : positive CHMP opinion for Rasilamlo(TM), a single-pill combination of aliskiren and amlodipine to treat high blood pressure

February 18, 2011 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Rasilamlo(TM) (aliskiren and amlodipine) to treat high blood pressure patients not adequately controlled by either aliskiren or amlodipine alone. Rasilamlo combines in a single pill the only approved direct renin inhibitor worldwide, Rasilez®, with the widely used calcium channel blocker amlodipine.

The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in approximately three months.

"We are delighted with the CHMP opinion because it means that Rasilamlo could soon be made available to patients in the EU in need of effective combination treatments to help control their high blood pressure," said David Epstein, Division Head of Novartis Pharmaceuticals. "Novartis understands the complex needs of high blood pressure patients and is committed to furthering cardiovascular research and to developing innovative and effective treatments."... Novartis' Press Release -

Viron : Phase 2a Data Published in Leading Cardiovascular Journal

December 16, 2010 - Viron Therapeutics Inc. announced that the results of Viron's Phase 2a trial for VT-111 were published in Circulation: Cardiovascular Interventions. In the study led by Dr. Jean-Claude Tardif, Director of the Research Centre at the Montreal Heart Institute, VT-111, also known as Serp-1, met both its primary and secondary endpoints of safety and biological activity in Acute Coronary Syndrome (ACS) patients receiving coronary stents. VT-111 is a protein produced by the myxoma virus that allows the virus to lower its host's inflammatory response to infection.


"Although the use of cardiovascular stents have dramatically improved the outcomes for patients with occlusive coronary artery disease, numerous studies have shown that the procedure itself can cause what is termed peri-procedural myocardial injury (PMI)," said James Rae, CEO of Viron. "A recent review in the European Heart Journal shows that 30% of patients receiving coronary stents sustain an injury to the heart tissue arising from the procedure itself and the biomarkers most useful in measuring this cardiac injury are CK-MB and Troponin I. Viron's Phase 2a trial showed a statistically significant, dose-dependent reduction in these two key biomarkers of cardiac damage, at multiple timepoints, with a particularly potent effect in the first 24 hours after the placement of the stent. If the incidence of PMI was reduced, clinical outcomes would improve for many of the almost 3 million patients each year that receive cardiac stents in North America and Europe." ... Viron Therapeutics' Press Release -