Serodus licenses compound from Roche for potential treatment of heart failure

9 December 2010 - Serodus has entered into a license agreement with Roche for a selective serotonin-4 (5-HT4) antagonist for the potential treatment of heart failure (RO1160367). Under the Agreement, Serodus will receive the full preclinical and clinical documentation for RO1160637. In return, Roche will receive an upfront payment as well as be entitled to receive development, regulatory and commercial milestone payments. Roche is also eligible to receive royalties on sales of products commercialized under the license. Serodus has been granted the exclusive development, manufacturing and worldwide marketing and sale rights with the rights to sub-license.


In certain cases, Roche has a right to negotiate to regain the product rights... Serodus' Press Release -

Micell Technologies : First Patient in DESSOLVE I First-In-Human Study of MiStent DES

November 29, 2010- MiStent DES Delivers Sirolimus via Bioabsorbable Polymer; Drug and Polymer are Designed to be Eliminated within 90 days with Optimized Dissolution Kinetics - Micell Technologies,™ Inc. announced it has enrolled at Mercy Hospital in Auckland, New Zealand, the first patient in DESSOLVE I (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lEsions in the native coronary arteries), a first-in-human clinical trial of the company’s investigational MiStent™ Drug Eluting Coronary Stent System (MiStent DES).

DESSOLVE I is a prospective, open-label, non-randomized, single-arm study that is expected to enroll 30 patients at five clinical sites in Belgium, Australia and New Zealand. Candidates for the trial are patients with documented stable or unstable angina pectoris or ischemia. The primary endpoint is in-stent late lumen loss, as measured with angiography in treated de novo lesions ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm long stent.

Along with secondary clinical endpoints such as major adverse cardiac events and revascularization rates, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) will also be employed at multiple timepoints. The DESSOLVE I study uses multiple imaging modalities to better understand the time to complete tissue coverage of the stent struts relative to polymer absorption... [PDF] Micell Technologies' Press Release -

Schiller AG and BSP : agreement for the development of a new product line based on BSP's HyperQ™ technology

November 8, 2010 - SCHILLER AG, a leading international manufacturer and supplier of cardiopulmonary diagnostics and BSP Biological Signal Processing Ltd., a medical device company that develops and markets innovative solutions for noninvasive cardiac diagnosis and monitoring , announced on November 8th, 2010 the signing of an agreement to jointly develop a new product line based on BSP’s HyperQ™ technology. The project will be performed in collaboration with the University Hospital of Basel, one of the premier medical centers in Europe. The project is planned for 3 years with an overall estimated budget of 1.7 Million Euro and will be partly funded by the Swiss and Israeli governments within the prestigious EUROSTARS framework.

The new product line is intended for the lucrative market of resting electrocardiogram (ECG) applications for the early diagnosis and monitoring of myocardial ischemia in patients with suspected acute coronary syndrome, including myocardial infarction (MI). This collaboration comes in continuation to the successful implementation of BSP’s HyperQ™ Analyzer in Schiller's state of the art CS-200 Excellence machine, a system intended for the stress ECG market, which was launched in Medica 2009.

The HyperQ™ technology utilizes advanced signal processing to extract and analyze valuable clinical information from high-resolution ECG signals. Based on solid scientific foundations, and validated in numerous pre-clinical and clinical studies, HyperQ™ provides a novel diagnostic tool for the non-invasive diagnosis of ischemic heart disease, with superior accuracy, compared to conventional ECG... BSP's Press Release -

BLUE MEDICAL : EUROPEAN CE MARK APPROVALS FOR DRUG ELUTING BALLOON AND STENT ON DRUG ELUTING BALLOON COMBINATION DEVICE

Nov. 15, 2010 - BLUE MEDICAL RECEIVES EUROPEAN CE MARK APPROVALS FOR DRUG ELUTING BALLOON AND STENT ON DRUG ELUTING BALLOON COMBINATION DEVICE - First ever CE approved combination device is an attractive treatment for coronary artery diseases - Blue Medical announced that the company received CE Mark approval for Blue Medical science based Drug Eluting Balloon (DEB) and simultaneously for Blue Medical's coronary CoCr stent mounted on a Drug Eluting Balloon (CoCr Stent on DEB) in Europe for treatment of coronary diseases. DEB therapy delivers a controlled dose of Paclitaxel to the coronary artery during balloon angioplasty. A unique combination of a one-time short and precise drug delivery with DEB during placement of a coronary stent is now for the first time approved and available in Europe.

"Increased late stent thrombosis risk and the long term dual anti-platelet medication which are associated with the majority of current drug eluting stents is a concern in treating our patients today," said Primary Investigator of the PIONEER Study Peter Smits, M.D., head of Intervention Cardiology at the Maasstad Hospital, Rotterdam, The Netherlands. "DEB therapy in combination with bare metal coronary stents offers a potential solution for reducing late lumen loss without the need for long term dual-anti-platelet medication, improving patent comfort and reducing risks for bleeding and stent thrombosis."... Blue Medical's Press Release -

BioInvent : approval to start Phase II trial for its novel cardiovascular drug BI-204

10 November 2010 – BioInvent International AB (OMXS: BINV) announces IND clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase II study for BI-204. BI-204 is a human monoclonal antibody that specifically targets oxidized forms of a low-density lipoprotein (LDL) which has been linked to increased inflammatory processes leading to plaque formation in the blood vessel walls. BI-204 is being co-developed with Genentech for secondary prevention of cardiovascular events in patients with acute coronary syndrome (ACS).


The Phase II study is a multicenter, randomized, double-blind, placebo-controlled study of intravenous BI-204 in patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. Inflammation plays a critical role in the pathogenesis of atherosclerosis. The trial is designed to demonstrate a significant reduction in plaque inflammation following treatment with BI-204 as quantified by FDG-PET (18F 2‑deoxyglucose positron emission tomography). The trial will enrol 120 patients with stable coronary vascular disease in centers in the United States and Canada. The topline results of the study are expected to be reported in the first half of 2012. Additional trials are being contemplated in patients with ACS prior to commencing Phase III....BioInvent's Press Release -

Tryton Medical : First Patient Enrollment in E-Tryton Italy Registry of the Tryton Side Branch Stent System

Oct. 12, 2010 - Study To Assess Real-Life Clinical Results in 300 Patients With Bifurcation Disease in Italy - Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, announced that the first patient has been enrolled in E-Tryton Italy, a registry study of the company’s Tryton Side Branch Stent™ System. E-Tryton Italy is one of four registries in Europe evaluating the Tryton Side Branch Stent System in real-world clinical settings.
The Tryton Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. Tryton’s highly deliverable cobalt chromium stent is deployed in the side branch artery using standard single-wire balloon expandable stent delivery system. A conventional drugeluting stent is then placed in the main vessel... [PDF] Tryton Medical's Press Release -

Otsuka Pharmaceutical / SAMSCA™ Tablets 15mg (tolvaptan), Vasopressin V2-Receptor Antagonist, Receive Regulatory Approval in Japan

October 27, 2010 – Otsuka Pharmaceutical Co., Ltd. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved SAMSCA™ (nonproprietary name: tolvaptan), a vasopressin V2-receptor antagonist, for the treatment of excess water retention in patients with cardiac failure when the treatment by other diuretics including loop diuretics is ineffective.

SAMSCA is a nonpeptide vasopressin V2-receptor antagonist discovered by Otsuka Pharmaceutical in 1991 with a unique mechanism of action that selectively blocks the binding of vasopressin to the V2-receptors in the collecting duct of the kidney. The binding of vasopressin with V2-receptors can cause water retention. By inhibiting the effects of vasopressin at the V2-receptor, SAMSCA increases the excretion of free water and reduces the re-absorption of water from urine into the blood without directly affecting the excretion of sodium and other electrolytes.

"Our research and development on vasopressin V2-receptor antagonists, that began in the early 1980s, was in response to requests from the medical profession for a diuretic that excretes only water," said Taro Iwamoto, Ph.D., President and Representative Director, Otsuka Pharmaceutical... Otsuka Pharmaceutical's Press Release -

Takeda: European Marketing Authorisation Application for Azilsartan Medoxomil, an Investigational Compound for the Treatment of Essential Hypertension

October 20, 2010 – Takeda Pharmaceutical Company Limited (Takeda) announced that Takeda Global Research & Development Centre (Europe), Ltd. submitted a Marketing Authorisation Application (MAA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB), to the European Medicines Agency (EMA) for the treatment of essential hypertension. The EMA has confirmed that the submission has been validated for assessment.

High blood pressure, or hypertension, was responsible for 7.6 million preventable deaths worldwide in 2001. Almost half (44 percent) of the adult population in Europe is affected by hypertension - much (approximately 60 percent) higher than in the United States and Canada. Discovered by Takeda, azilsartan medoxomil is a prodrug of the active moiety azilsartan, which lowers blood pressure by blocking the action of a vasopressor hormone, angiotensin II. The discovery and development of azilsartan medoxomil continues Takeda’s commitment to the treatment of hypertension, and builds upon the company’s long-standing clinical experience with its previously discovered antihypertensive agent candesartan.

The MAA submission for azilsartan medoxomil monotherapy was supported by positive results from a clinical development program which included nine phase 3 clinical trials in which approximately 7000 subjects with essential hypertension were enrolled of whom 4814 unique subjects received at least 1 dose of azilsartan medoxomil. The safety and efficacy of azilsartan medoxomil was studied for initial therapy as a once-daily oral monotherapy or for co-administration with other antihypertensive medications, including the diuretics chlorthalidone and hydrochlorothiazide, and the calcium channel blocker, amlodipine. It was also studied in comparison with olmesartan medoxomil, valsartan6 and ramipril... Takeda' Press Release -

SynCardia Systems : UCSD Medical Center to Begin Certification for Total Artificial Heart

Oct. 14, 2010 - World Renowned Heart Surgeon Dr. Jack Copeland Brings World's Only Approved Total Artificial Heart to La Jolla – SynCardia Systems, Inc. announced that the University of California, San Diego (UCSD), led by Stuart W. Jamieson, M.B., F.R.C.S., Head of Cardiothoracic Surgery, will begin certification to implant the SynCardia temporary Total Artificial Heart. Efforts to bring the Total Artificial Heart to UCSD were led by world renowned heart surgeon, Dr. Jack Copeland, who joined the faculty in July.
"One of my main goals is to help support the heart transplant and ventricular assist device program at UCSD," said Dr. Copeland. "Many patients who need a heart transplant won't live long enough to receive one. The Total Artificial Heart is the only device capable of saving even the sickest patients and bridging them to transplant. At UCSD, I hope to achieve, if not surpass, the level of success we experienced with the Total Artificial Heart at University Medical Center in Tucson."
In 1990, UCSD performed its first heart transplant and has performed 180 overall with excellent results. In 2011, construction is expected to be completed for UCSD's new $227 million Sulpizio Family Cardiovascular Center, a 128,000-square-foot facility which will house heart and stroke care in one location... SynCardia Systems' Press Release -

Welch Allyn : Connex® ProBP™ 3400 to Markets Outside the US and Canada

2010-10-04 - Welch Allyn Introduces Handheld Digital Blood Pressure Device to Markets Outside the United States and Canada - Connex® ProBP™ 3400 delivers fast, reliable, EMR-ready blood pressure readings using company’s patented SureBP™ technology and Bluetooth® wireless technology
Welch Allyn, a leading global provider of frontline medical products and solutions, today introduced the Connex® ProBP™ 3400, an automated digital blood pressure device designed to fit in the palm of the hand. Borrowing Welch Allyn SureBP™ technology from the company’s multiparameter vital signs devices, the Connex ProBP delivers fast, accurate blood pressure readings with the durability of Welch Allyn’s popular hospital-grade vital signs devices. Now available in markets outside the United States and Canada, the Welch Allyn Connex ProBP is easy to use and provides a portable option for capturing reliable blood pressure readings in virtually any hospital or primary care environment.
“In today’s demanding healthcare environment, providers sometimes need a single, simple and easy-to-use blood pressure device that can capture readings quickly, easily and accurately... Welch Allyn's Press Release -

Cardiac Science : MTWA Module for Stress Testing

Sept 21, 2010 - Company Extends Leadership in Stress Category - Cardiac Science Corporation (Nasdaq: CSCX), a global leader in automated external defibrillator (AED) and diagnostic cardiac monitoring devices, announced the launch of a Microvolt T-Wave Alternans (MTWA) module that integrates with its industry-leading Quinton Q-Stress cardiac stress systems.

"Physicians that have Q-Stress systems can add the MTWA module to their existing Q-Stress systems, or order it as an option with new systems," said Tony Titus, Cardiac Science vice president of marketing. "The MTWA test is a clinically proven test for assessing the risk of sudden cardiac arrest and it can be performed during a standard stress test session. It is the only test of its kind that Medicare will reimburse... Cardiac Science's Press Release -

Edwards Lifesciences : Approval to Begin U.S. Clinical Trial of Next-Generation Transcatheter Valve

September 23, 2010 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that the U.S. Food and Drug Administration (FDA) conditionally approved the first of two planned cohorts of the randomized, controlled The PARTNER II Trial. Building upon the learnings of the world's first randomized transcatheter heart valve trial -- Edwards' The PARTNER Trial -- the first cohort of The PARTNER II Trial will study the next-generation Edwards SAPIEN XT transcatheter heart valve. This trial includes the low-profile NovaFlex transfemoral delivery system, which broadens the number of eligible patients... Edwards Lifesciences' Press Release -

Sanofi-aventis : Largest Atrial Fibrillation Registry Reveals Poor AF Control and High Rates of Cardiovascular Hospitalization

September 1, 2010 - Over 10,000 Patients Included in RealiseAF – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that results from the RealiseAF (Real-life global survey evaluating patients with Atrial Fibrillation) registry show that control of atrial fibrillation (AF) (defined by the 2006 ACC/AHA/ESC AF guidelines as either sinus rhythm or AF with heart rate at rest ≤ 80 bpm) was not achieved in more than 40 percent of the AF patients included in this 10,000 patient cross-sectional registry, as presented during the European Society of Cardiology Congress in Stockholm, Sweden. In addition, the registry revealed that a majority of patients complain of symptoms, even when AF is controlled (55.7 percent).
Importantly, cardiovascular (CV) events were very frequent in this population, with a high rate of concomitant CV risk factors (72.2% of patients were hypertensive and 46.3% of patients had dyslipidemia) 28.7 percent of AF patients suffered from CV events such as acute coronary syndrome (ACS) acute heart failure or stroke, leading to an unplanned hospitalisation during the last 12 months and 12.4 percent of patients requiring major CV interventions such as Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG) or valvular surgery... [PDF] Sanofi-aventis' Press Release -

Cardica : Multi-Vessel Minimally-Invasive Cardiac Bypass Surgery Using Automated Stapling Devices

Sept 14, 2010 - Nationally-renowned cardiovascular and thoracic surgeon Mahesh Ramchandani, M.D. of the Methodist DeBakey Heart & Vascular Center in Houston is innovating minimally-invasive cardiac surgery using Cardica, Inc.'s (Nasdaq: CRDC) C-Port(R) Distal Anastomosis and PAS-Port(R) Proximal Anastomosis Systems. Dr. Ramchandani offers patients an alternative to traditional "open chest" bypass procedures without cutting the sternum using the minimally-invasive cardiac surgery/coronary artery bypass graft (MICS CABG).

"MICS is not just a surgical procedure, it is an attitude towards minimally-invasive cardiac surgery, taking a logical, structured, step-wise approach with patient safety as its paramount concern... Cardica's Press Release -

Cardiovascular Systems : First Patient in ORBIT II Coronary Clinical Trial

May 26, 2010 - Pivotal Study Evaluating the Clinical Benefits of Treating Calcified Coronary Lesions with the Diamondback 360° System – Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announces the first patient enrollment in its ORBIT II Investigational Device Exemption (IDE) clinical trial to evaluate the safety and effectiveness of its Diamondback 360® System in treating coronary arteries. The patient was treated by Dr. P.K. Khanna, an interventional cardiologist with Eisenhower Medical Center in Palm Springs, Calif. Dr. Khanna also treated patients in the 2008 ORBIT I coronary study of 50 patients in India. ORBIT I showed that the Diamondback 360° was successful in 98 percent of patients with calcified lesions, with an acute procedural success rate of 94 percent.

“Severely calcified coronary lesions have frequently been excluded from other clinical studies over the past decade because they are a clinical challenge for coronary interventions,” Dr. Khanna said. “I believe that the Diamondback 360° is an essential advancement in treating patients with this type of disease. This easy-to-use tool should prove — through the ORBIT II trial — to be safe and effective in treating calcified lesions in order to facilitate stent placement.”

The ORBIT II study advances CSI’s progress toward U.S. regulatory approval for a coronary application and a significant market expansion. CSI received unconditional FDA IDE approval for the ORBIT II study in April 2010. The pivotal trial will initially enroll up to 100 patients, with the potential to enroll up to 429 patients... Cardiovascular Systems' Press Release -

Cardioxyl Pharmaceuticals : Dose-Defining Phase IIA Study of Its Lead Candidate, CXL-1020, in Heart Failure Patients

August 26, 2010 - Following Positive Results in Phase I/IIa Dose Escalation Trial, Cardioxyl Continues to Evaluate Clinical Safety and Tolerability of CXL-1020 – Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutic agents for the treatment of cardiovascular disease, announced that it has initiated a dose-defining Phase IIa trial of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure (ADHF). ADHF is the leading diagnosis for patients at the time of discharge from U.S. hospitals and the most common cause of hospitalization for patients over 65 years of age.
"Following the significant clinical results from our recently completed Phase I/IIa dose escalation study demonstrating CXL-1020's attractive hemodynamic and safety profile, we are excited to continue to evaluate this important new therapy for patients with ADHF,"... Cardioxyl Pharmaceuticals' Press Release -

Boston Scientific : First Patient Enrollment in MultiSENSE Clinical Trial

July 8, 2010 - Boston Scientific Corporation (NYSE: BSX) announced enrollment of the first patient in its MultiSENSE clinical trial. The trial is designed to evaluate multiple physiologic sensors in the Company's COGNIS™ cardiac resynchronization therapy defibrillators (CRT-Ds). Boston Scientific plans to use the trial data to help develop a clinical alert that identifies the early onset of worsening heart failure. The first patient was enrolled by Paul Coffeen, M.D., Austin Heart, Austin, Texas, where Jeffrey Whitehill, M.D., Medical Chair, Electrophysiology Department, is the site's Principal Investigator.
When combined with the Company's LATITUDE® Patient Management System, CRT-D sensors would be able to monitor a patient outside of a clinical setting and permit the LATITUDE system to deliver early notification to the physician when the patient's heart failure worsens.
"Heart failure is a complex disease and physicians use a number of diagnostics to assess a patient's condition and disease progression,"... Boston Scientific's Press Release -

BSP granted CE mark for its HyperQ AD-100 product enabling improved diagnostic performance of Stress ECG

June 27, 2010- BSP announced that the CE mark was granted to its HyperQ AD-100 and HyperQ-AN products.

BSP, which develops and commercializes advanced products for the non invasive, accurate diagnosis of heart diseases, announced that its Add-On product, the HyperQ AD-100, intended for improved diagnostic performance of Stress ECG, has been granted the European CE conformance mark. The HyperQ AD-100 product is an add-on system with the HyperQ technology which is incorporated in parallel to existing standard stress ECG systems. The integration of the HyperQ AD-100 into Stress ECG systems enables accurate and sensitive diagnosis of Ischemic Heart Disease, a leading cause of death in the world.

The unique technology developed by BSP is implemented in a non invasive manner and does not involve exposure to radiation or other hazards to patients. It is highly effective in diagnosing sick people and in ruling out disease in healthy individuals. The HyperQ AD-100 enables physicians to benefit from the clinical advantages of the technology without the need to replace their existing installed Stress ECG system... BSP 's Press Release -

Acorda Therapeutics : Receipt of NIH Grant for Development of GGF2 in Heart Failure

Jul 20, 2010 -- Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced the National Heart, Lung, and Blood Institute (NHLBI) has awarded a $1 million Cardiac Translational Research Implementation Program (C-TRIP) grant to support research on Glial Growth Factor 2 (GGF2), a novel investigational agent for the treatment of patients with heart failure under development at Acorda. The grant, supporting both clinical and laboratory studies, was awarded jointly to Acorda and Vanderbilt University Heart and Vascular Institute, which are collaborating on research of GGF2 in heart failure. The first clinical study for GGF2 in patients with heart failure is expected to begin in mid-2010.

"Collaboration is often critical to important scientific advances, and we are excited to be working with Vanderbilt University Heart and Vascular Institute, a leading cardiac treatment and research center, to explore the use of GGF2 in heart failure,"... Acorda Therapeutics' Press Release -

Cardiome : Investigational BRINAVESS™ (vernakalant) for Infusion Recommended for Approval by the CHMP in the European Union (EU) for ...

June 25, 2010 - Investigational BRINAVESS™ (vernakalant) for Infusion Recommended for Approval by the CHMP in the European Union (EU) for the Rapid Conversion of Recent Onset Atrial Fibrillation — Merck (known as MSD outside the United States and Canada) (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS™ (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

The CHMP issued the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of vernakalant. The proposed indication for vernakalant is for the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.



Granting of marketing authorization by the European Commission is expected later this year and will apply to the 27 countries that are members of the EU plus Norway and Iceland. If approved by the European Commission, vernakalant would be the first product in a new class of pharmacologic agents for cardioversion of atrial fibrillation to launch in the EU... Cardiome Pharma's Press Release -

Pfizer : Caduet Reduces 10-Year Calculated Risk Of Coronary Heart Disease, Fatal Cardiovascular Disease

June 21, 2010 – Caduet® (amlodipine besylate/atorvastatin calcium) was associated with a significantly reduced calculated 10-year risk of coronary heart disease (CHD) based on a Framingham risk assessment model. In addition, Caduet was shown to reduce calculated fatal cardiovascular disease (CVD) risk, as a secondary trial endpoint based on the SCORE risk assessment model. The Framingham and SCORE risk assessment models are widely used in the U.S. and EU, respectively. These data from the CRUCIAL (Cluster Randomized Usual Care vs. Caduet Investigation Assessing Long-term Risk) trial were presented yesterday at the 20th Scientific Meeting of the European Society of Hypertension (ESH) in Oslo, Norway.

“The data presented at ESH are important because they show the potential benefit of Caduet, which combines blood pressure and cholesterol-lowering medications in a single pill, over usual care in a real-life clinical setting... Pfizer's Press Release -

St Jude Medical : Acquisition of LightLab Imaging

Jul 06, 2010 - St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, completed the previously announced acquisition of LightLab Imaging, Inc. for approximately $90 million in cash.
LightLab is the pioneer and leader in the development of Optical Coherence Tomography (OCT), a high resolution diagnostic coronary imaging technology which aids physicians in the treatment of cardiovascular disease.

The acquisition of OCT technology accelerates the expansion of St. Jude Medical's cardiovascular growth platform by providing the company with a comprehensive product offering that will allow the Company to compete in, and potentially expand, the intravascular imaging market. The IVUS market is estimated to be $500 million for 2010 and to grow 10 to 15 percent annually.

During the second half of 2010, St. Jude Medical expects the OCT platform to contribute an additional $20 million in revenue to its cardiovascular business. The OCT market is expected to grow at a double-digit compounded annual rate over the next five years and is expected to capture IVUS market share... St. Jude Medical's Press Release - [PDF] LightLab Imaging's Press Release -

Cardio3 BioSciences : Positive Three‐Month Data from its Clinical Trial of C‐Cure® in Heart Failure

June 29, 2010 - Cardio3 BioSciences, a leading Belgian biotechnology company specialising in regenerative therapies for the treatment of cardiovascular diseases, announces positive safety data and preliminary efficacy results from its clinical trial of C‐Cure®, a breakthrough stem cell therapy for heart failure.
Results showed C‐Cure to have a very good safety profile with no adverse events related to C‐Cure, as assessed by an independent board. The study is also examining a number of measures of efficacy. With three month follow up data in‐hand, Cardio3 BioSciences has observed positive and encouraging trends in a number of physiological and clinical parameters. Meaningful differences were seen in ventricular size, ejection fraction and other measures of heart muscle activity in C‐Cure treated patients when compared to control and to baseline. Partial data from a paired analysis of patients at six‐months follow‐up is suggestive of these beneficial trends being reinforced over time. Cardio3 Biosciences intends to publish the study results once the full six month dataset is available and has been analysed... [PDF] Cardio3 BioSciences' Press Release -

Anthera Pharmaceuticals : First Patients in Pivotal Varespladib Phase 3 Clinical Study

June 23, 2010 - Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, announced patient enrollment has commenced in the Company's pivotal VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome for 16 Weeks) Phase 3 clinical study of varespladib (A-002). High-risk patients are defined as those who have additional disease characteristics that increase their likelihood of experiencing another coronary event; these characteristics include a history of previous cardiovascular disease, age, diabetes, or metabolic syndrome.
"Current best practice to slow coronary artery disease (CAD) progression and reduce the risk of a subsequent cardiovascular event is directed at the treatment of individual cardiovascular risk factors such as high cholesterol or clotting. The VISTA-16 study with varespladib is designed to validate the hypothesis that reduction of inflammation, particularly following an ACS, leads to improved outcomes in patients with cardiovascular disease. The enrollment of patients in VISTA-16 is an important milestone for the development of varespladib,"... Anthera Pharmaceuticals' Press Release -

Santaris Pharma and miRagen Therapeutics : Strategic Alliance to Develop microRNA-targeted Medicines for the Treatment of Cardiovascular Disease

June 23, 2010 — Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies and miRagen Therapeutics, Inc., a biopharmaceutical company focused on developing innovative microRNA-based therapeutics for cardiovascular and muscle disease, announced today that they have formed a strategic alliance to develop microRNA-targeted medicines for the treatment of cardiovascular disease.

Cardiovascular disease is the number one cause of death worldwide, claiming 17.1 million lives a year, or 29 percent of all deaths globally1. An estimated 81 million American adults – more than one in three – have one or more types of cardiovascular disease, which include high blood pressure, coronary heart disease, congenital cardiovascular defects, heart attack, chest pain, heart failure and stroke2.


miRagen is planning to develop and commercialize single-stranded LNA-based product candidates intended for the treatment of cardiovascular disease by utilizing Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform. Under the terms of the agreement, Santaris Pharma A/S received a minority equity interest in miRagen, and is eligible to receive milestone payments and royalties upon achievement of certain development and regulatory milestones. Financial terms of the collaboration were not disclosed... Santaris Pharma's Press Release - miRagen Therapeutics' Press Release -

NormOxys : Phase 1 Clinical Trial of Allosteric Effector of Hemoglobin, OXY111A

May 24, 2010 - NormOxys Inc., a biotechnology company developing a novel class of small molecule drugs which enhance the body’s ability to deliver oxygen to diseased tissues, announced that it has initiated a Phase 1 clinical trial of OXY111A, a novel allosteric modulator of affinity of oxygen to hemoglobin. NormOxys plans to initially develop this compound as a treatment for chronic heart failure and cancer indications. The Phase 1 trial will evaluate OXY111A in healthy volunteers at escalating dose levels.
The randomized, single-blind, ascending dose design will assess the safety, tolerability and pharmacokinetics of single intravenous doses of OXY111A in healthy volunteers. Biomarkers in this study include the measurement of P50, which evaluates the proof of pharmacology by quantifying changes in oxygen affinity produced by OXY111A as well as cardiopulmonary exercise testing to assess clinical improvements in oxygen delivery. Following this study will be safety and efficacy studies in chronic heart failure and oncology indications... [PDF] NormOxys' Press Release -

SORIN GROUP ACQUIRES GISH BIOMEDICAL

June 8, 2010 – Sorin Group, (Reuters Code: SORN.MI), a global company and a leader in the treatment of cardiovascular diseases, announced that it has acquired Gish Biomedical from Ventizz Capital Partners, a private equity group focused on technology-oriented companies.

Based in California, Gish Biomedical designs and manufactures disposable medical devices for cardiovascular surgery, with a focus on the Perfusionist. Gish products have been marketed both in the United States and worldwide for over 25 years... Sorin Group's Press Release - [PDF] GISH Biomedical's Press Release -

Medtronic's CoreValve® System : Long-Term Efficacy and Durability in Pivotal Trial

May 26, 2010 - Market-Leading Transcatheter Aortic Valve Delivers Positive Clinical Outcomes Through Two Years in Major International Study; Achieves 10,000-patient Milestone – New clinical data presented at EuroPCR demonstrate positive long-term performance and durability for the CoreValve transcatheter aortic valve replacement system from Medtronic, Inc. (NYSE: MDT). Two-year results from the pivotal 18-French CoreValve multicenter prospective study provide important additional evidence supporting wider use of the world’s market-leading transcatheter aortic valve.

The CoreValve system received CE (Conformité Européenne) Mark in March 2007. It is not yet available in the United States for clinical trial or commercial sale or use.

The CoreValve system, designed to replace a diseased aortic valve without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 32 countries outside the United States. Typically delivered through the femoral artery, CoreValve is used in 75 percent of transarterial transcatheter valve replacement procedures... Medtronic's Press Release -

AstraZeneca : Marketing Authorisation Application To European Union For Cardiovascular Drug Axanum

04 June 2010 - AstraZeneca announced that it has submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for a product combining low-dose ASA (acetylsalicylic acid) and the active ingredient of Nexium (esomeprazole) for the prevention of cardio- and cerebrovascular (CV) events in patients requiring continuous low-dose ASA treatment who are at risk of developing ASA-associated gastric and/or duodenal ulcers. Pending approval, the proposed trade name for the product is Axanum.

Low-dose ASA, commonly known as aspirin, is a mainstay of therapy for patients at high risk of a CV event such as myocardial infarction or stroke. However, upper GI problems (including symptoms, ulcers and ulcer-related complications) are common reasons for discontinuing low-dose ASA therapy. Up to 30% of patients with upper GI problems discontinue or take deliberate breaks from their low-dose ASA treatment, which can place them at risk of a potentially life-threatening CV event as early as 8-10 days after discontinuation... AstraZeneca's Press Release -

CardioMEMS : CHAMPION Clinical Trial Study

June 1, 2010 - Study results indicate that the CardioMEMS implantable hemodynamic monitoring system significantly reduces the leading cause of hospitalizations in the U.S. - The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial met its primary efficacy endpoint with a 30% reduction in heart failure hospitalization rates at 6 months in heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, permanent wireless implant.

The results were presented this week at the European Society of Cardiology Heart Failure Congress 2010 in Berlin, Germany, by the principal investigators of the trial: William Abraham, M.D., Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center, and Philip Adamson, M.D., Director of the Heart Failure Institute at the Oklahoma Heart Hospital. The study was sponsored by CardioMEMS, Inc., a medical technology company that has developed a novel wireless sensing and communication technology for the human body... CardioMEMS' Press Release -

Trevena : Clinical Development of TRV120027, a First-in-Class Biased Ligand

April 14, 2010 - Trevena Inc., a leader in the discovery of G-protein coupled receptor (GPCR) biased ligands, announced the initiation of a Phase I clinical trial of TRV120027, a titratable i.v. agent designed for the treatment of acute decompensated heart failure. TRV120027 is a biased ligand that targets the angiotensin II type 1 receptor (AT1R) and induces a unique mode of signaling. It simultaneously blocks angiotensin-mediated G-protein signaling while stimulating AT1R-specific β-arrestin signaling. In preclinical studies, this biased signaling has demonstrated a unique range of biological effects that are highly advantageous to patients with acute heart failure... Trevena's Press Release -

Vicor Technologies : Results of PD2i® Analysis of MUSIC Trial Data

May 19, 2010 — David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), announced the initial results of a study designed to analyze data from the Merte Subita en Insufficiencia Cardiaca (MUSIC) Trial using its PD2i® algorithm and software. Vicor Technologies is a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i® nonlinear algorithm and software. Vicor develops diagnostics that accurately risk stratify specific target populations for future pathological events including cardiac death and autonomic nervous system dysfunction, and trauma victims in need of lifesaving intervention.

The study, titled "Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure," was conducted under a collaborative agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona... Vicor Technologies' Press Release -

InVasc Therapeutics : Awarded Two Phase 1 SBIR Grants

May 19, 2010 – InVasc Therapeutics, Inc. announced that it has been awarded two Small Business Innovations Research (SBIR) Phase 1 grants by the National Institutes of Health. One grant is to continue research and development of small molecule drugs for the prevention and treatment of hypertension and stroke based on derivatives of alpha lipoic acid. The second grant is to advance the discovery and development of inhibitors of myeloperoxidase for use in treating or preventing acute vascular or inflammatory events. The aggregate funding from these two Phase 1 grants is nearly $400,000... [PDF] InVasc Therapeutics' Press Release -

Cardiola : m.pulse® system “immediately improves cardiac output under acute non-invasive Muscular CounterPulsation (MCP) treatment in patients with...

April 23, 2010 - Clinical study demonstrates that Cardiola’s m.pulse® system “immediately improves cardiac output under acute non-invasive Muscular CounterPulsation (MCP) treatment in patients with patients with stable CHF” (chronic heart failure) - Data presented at annual congress of the German Society of Cardiology — Cardiola AG announced that the Company’s CE-Marked m.pulse® Muscular CounterPulsation (“MCP”)-based system demonstrated “an immediate improvement of cardiac output with non-invasive means” in a patient population of advanced yet stable chronic heart failure. The effects could be shown in 22 patients over three consecutive days.... [PDF] Cardiola's Press Release -

Cordis : First Patients Enrolled In Trial of New Stent Graft System To Treat Abdominal Aortic Aneurysm

April 9, 2010 - Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technologies, announced that the first patients have been enrolled in the INNOVATION trial, which will assess the safety of a new stent graft system, called INCRAFT™, to treat abdominal aortic aneurysm (AAA). An estimated 27 million people worldwide have abdominal aortic aneurysms. Left untreated, all aneurysms will eventually rupture, and more than 80% of aneurysms that rupture result in death. In the U.S. alone, approximately 15,000 people die every year due to an AAA rupture... Cordis' Press Release (JNJ) -

HeartWare : Data From First 100 Patients in International Clinical and Commercial Experience Shows 90% Survival at 180 Days

April 23, 2010 -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, announced that data from its international clinical trial and commercial experience of the HeartWare® Ventricular Assist System showed a survival rate of 90 percent at six months and an actuarial survival rate of 86 percent at 12 months post implant. The results were presented by Martin Strueber, M.D., cardiothoracic surgeon at Hannover Medical School, at the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) held in Chicago this week... HeartWare International's Press Release -

Juventas Therapeutics : Phase I Clinical Trial of JVS-100 for Patients with Heart Failure

April 5 2010 - Juventas Therapeutics, Inc. is formerly known as AcelleRX Therapeutics, Inc. - Juventas Therapeutics, a privately held, clinical-stage regenerative medicine company announced it has started enrolling patients in a Phase I clinical trial for JVS-100 to evaluate safety and efficacy in the treatment of patients with Class III heart failure. JVS-100 encodes Stromal Cell-derived Factor-1 (SDF-1) and has been shown in pre-clinical studies to significantly increase cardiac function by promoting cell survival and increasing new blood vessel formation in the damaged organ. Specifically, the company completed studies in heart failure pig models demonstrating that JVS-100 treated pigs showed statistically significant improvements in key indicators of cardiac function and remodeling including reductions in left ventricular end systolic volume. Douglas Losordo, M.D., the Director of the Feinberg Cardiovascular Research Institute at Northwestern University serves as the Principal Investigator for the 16 person first-in-man, open-label, dose-escalation study. Also serving as Investigators are Drs. Farrell Mendelsohn, Director, Center for Therapeutic Angiogenesis Interventional & Regenerative Cardiovascular Medicine and Warren Sherman, the Director, Stem Cell Research and Regenerative Medicine for the Center for Interventional Vascular Therapies at Columbia University Medical Center... Juventas Therapeutics' Press Release -

Cardima : Surgical Ablation Probe Receives CE Mark Approval for the Surgical Treatment of Atrial Fibrillation

March 29, 2010 - Surgical Ablation System Capable of Closed-chest and Open-chest Ablation of Left and Right Atria to Mimic the MAZE Procedure - Cardima, Inc. (OTC/BB: CADM), a medical device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System, announced that it has received CE Mark approval with an Indication for the Surgical Treatment of Atrial Fibrillation for its Surgical Ablation Probe. All components of the Cardima Surgical Ablation System are now approved for marketing for the treatment of AF in European countries recognizing CE Mark approval.

The Cardima Surgical Ablation System can be used in open-chest surgery in conjunction with other procedures, or as a thoracoscopic stand-alone, closed-chest procedure. The closed-chest procedure is significantly less invasive than current prevailing surgical treatments for AF. The Cardima Surgical Ablation System allows a trained cardiac surgeon to gain access to the heart through two or three small ports in the chest, making a large incision or sternotomy unnecessary... Cardima's Press Release -

ARCA biopharma : Special Protocol Assessment Agreement with FDA for Bucindolol Development in Genotype-Defined Heart Failure Population

May 17, 2010 - ARCA biopharma, Inc. (Nasdaq: ABIO) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. Bucindolol is the Company's investigational, pharmacologically unique, beta-blocker and mild vasodilator. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. In November 2009, the Company announced that the FDA has designated as a Fast Track development program the investigation of bucindolol for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. In March 2010, ARCA was awarded a patent from the U.S. Patent and Trademark Office (USPTO) on methods of treating heart failure patients with bucindolol based on genetic testing.... ARCA biopharma's Press Release -

Phase 2 Clinical Trial Data Show Significant Improvements in Outcomes and Symptoms in Advanced Heart Failure Patients Treated with Celladon’s...

May 30, 2010 - Phase 2 Clinical Trial Data Show Significant Improvements in Outcomes and Symptoms in Advanced Heart Failure Patients Treated with Celladon’s Genetically Targeted Enzyme Replacement Therapy MYDICAR® - CUPID Trial Data Presented Today as Late-Breaker at Heart Failure 2010, the Annual Meeting of the Heart Failure Association of the European Society of Cardiology – Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that six-month data from its Phase 2 clinical trial of MYDICAR® show improvements in clinical outcomes and disease markers in advanced heart failure patients treated with the genetically targeted enzyme replacement therapy.

The study met its primary safety and efficacy endpoints for high dose MYDICAR® versus placebo. The primary efficacy endpoint is a composite endpoint that encompasses the simultaneous assessment of patients’ clinical outcomes, exercise tolerance, heart failure symptoms, biomarkers, and cardiac function. Barry Greenberg, M.D., Professor of Medicine at the University of California, San Diego, presented the data in advanced heart failure patients as a late-breaking trial presentation at Heart Failure Congress 2010, the annual meeting of the Heart Failure Association of the European Society of Cardiology... Celladon's Press Release -

Aastrom Biosciences : First Patient Treated in Aastrom's U.S. Phase 2 Catheter Clinical Trial in Dilated Cardiomyopathy

May 17, 2010 - Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, announced that the first patient has been treated in the company's U.S. Phase 2 catheter-based clinical trial to treat dilated cardiomyopathy (DCM). Treatment was performed by interventional cardiologist Timothy D. Henry, M.D., FACC, at the Minneapolis Heart Institute® at Abbott Northwestern Hospital in Minneapolis, MN.

This prospective, randomized, controlled, multi-center clinical trial is designed to determine the safety and tolerability of Aastrom's tissue repair cells (TRCs), administered via catheter, in the treatment of patients with heart failure due to DCM. The trial seeks to enroll 12 ischemic DCM and 12 non-ischemic DCM patients. Within each group patients are randomized to receive either TRC treatment along with standard-of-care, or control treatment (standard-of-care only) in a 2:1 ratio. While the primary objective of the trial is to assess safety in patients with DCM, efficacy measures including cardiac dimensions, heart failure stage and other measures of cardiac function will be monitored... Aastrom Biosciences' Press Release -

Cardium : Agreement With bioRASI to Advance and Broaden Clinical Development of Generx Product Candidate

Feb 16, 2010 - Cardium Therapeutics (NYSE Amex: CXM) announced that it has entered into an agreement with bioRASI, an international contract research organization, to assist Cardium in the evaluation of Generx clinical development opportunities within major newly-industrializing markets in Eastern Europe, Asia and Latin America, for patients with chronic coronary artery disease who are either not optimal candidates for or do not have access to costly angioplasty/stenting or cardiac bypass surgery procedures.


Despite progress in the care and treatment of patients with cardiovascular disease in the industrialized world, heart disease remains a very serious problem in the U.S. and Europe, and advanced surgical procedures have been associated with considerable and increasing expense within already-burdened healthcare systems. The situation is even worse in other parts of the world. In many industrializing countries such as China, India and Russia, as well as in Latin America and the Middle East, the incidence of heart disease is rapidly increasing, and healthcare systems in many of these countries are unable to provide wide access to relatively expensive procedures such as coronary angioplasty and stenting, or cardiac bypass surgery (which in the U.S. can cost $50,000 to $100,000 over a five-year period following initial treatment)... Cardium Therapeutics' Press Release -