MicroMed Cardiovascular's HeartAssist 5™ Goes Wireless

June 21, 2012 - Breakthrough Technology Advances Remote Monitoring Capabilities of the HeartAssist 5® System to Wirelessly Report Data when Patients are on the Move – MicroMed Cardiovascular Inc., manufacturer of the HeartAssist 5™ Left Ventricular Assist Device (LVAD), recently integrated the capacity for continuous wireless monitoring into its Conquest Controller. The Conquest Controller release is pending approval by regulatory agencies.

This unprecedented innovation will allow continual remote monitoring of data from the Heart Assist 5 LVAD. As a result, clinicians, doctors and technicians will be informed automatically and in the background without requiring the patient to do anything or having to come in to the clinic or hospital facilities.

Prior to MicroMed’s implementation of the M2M technology, clinicians could only access device data when the patient physically plugged the HeartAssist 5 into MicroMed’s HeartAttendant™ so that data could be transmitted via a local internet connection. The internet solution provided useful data, but limited patient mobility, and meant data reporting could not be continuous... MicroMed Cardiovascular's Press Release -

Loma Vista Medical : CE mark for its TRUE Dilatation™ Balloon Valvuloplasty Catheter

May 10, 2012 - Loma Vista Medical (“LVM”) announced that it has received CE mark for its TRUE Dilatation™ Balloon Valvuloplasty Catheter. The company has seen rapid adoption at major clinical centers and will be launching its initial product at next week’s EuroPCR congress in Paris (Booth #M22, Paris Convention Center Palais des Congrès).

Fabricated from tough, high-strength materials and designed to prevent the catastrophic failures seen with other heart valve dilatation balloons, the TRUE Dilatation Balloon is highly resistant to ruptures, punctures, and tears. Studies funded by the U.S. National Heart, Lung and Blood Institute (NHBLI) and others have reported a 10% to 17% failure rate in conventional balloons used in BAV (balloon aortic valvuloplasty) and TAVI (transcatheter aortic valve implantation) procedures... [PDF] Loma Vista Medical's Press Release -

Quantum Genomics : initiation of a First-in-Human clinical study with QGC001, its lead compound for the treatment of hypertension

April 13th 2012 - Quantum Genomics (NYSE Euronext Paris : MLQGC), following the approval from the French Agency for Safety of Health Products (AFSSAPS), announces the initiation of a phase I clinical study in healthy volunteers with its product QGC001. QGC001 is the first of a new class of drugs that is able to monitor high blood pressure by inhibiting the aminopeptidase A enzyme (APA) at the brain level.

Arterial hypertension affects an estimated 1 billion people worldwide (13 million people in France). Despite the availability of many antihypertensive drugs, 30% to 60% of patients diagnosed with hypertension do not have their blood pressure properly controlled by current medications for various reasons (49% in France ([1])). Moreover, the overall incidence of resistant hypertension to at least three antihypertensive drugs (including a diuretic) is estimatedaround 8% to 12% of the hypertensive population... Quantum Genomics' Press Release -

HeartWare International Expands Intellectual Property and Technology Portfolio Through Definitive Agreement to Acquire World Heart Corporation for US$8 Million

March 29, 2012 - HeartWare International, Inc. (Nasdaq:HTWR) (ASX:HIN), which develops and manufactures miniaturized ventricular assist devices, and World Heart Corporation (Nasdaq:WHRT), which has been engaged in the development of left ventricular assist devices, announced that they have entered into a definitive merger agreement under which HeartWare will acquire WorldHeart for consideration of US$8 million, which will be paid in shares of HeartWare common stock or cash, at HeartWare's election.

"WorldHeart has been an important participant in the development of ventricular assist therapies for many years and has amassed over one hundred patents and patent applications. In line with our goal to be a leader in the VAD market for years to come, we believe that bolstering our patent portfolio and adding WorldHeart's technologies broadens our options for the future," said Doug Godshall, President and CEO of HeartWare. "While we are intensely focused on the FDA panel for our HVAD® System next month, and commencement of first-in-man studies for our MVAD® System mid-year, we look forward to integrating WorldHeart's technologies and members of its talented team into our research efforts."... HeartWare International's Press Release - WorldHeart Corporation's Press Release  -

Asahi Kasei : Agreement to Acquire ZOLL Medical

March 12, 2012 - Builds on existing relationship to drive global development of critical care businesses –

Asahi Kasei Corporation (TSE1: 3407, hereinafter: Asahi Kasei), and ZOLL Medical Corporation (NASDAQ GS: ZOLL, hereinafter: ZOLL) jointly announced that Asahi Kasei, Japan’s leading diversified chemical manufacturer with businesses in the health care, chemicals & fibers, homes & construction materials, and electronics sectors, has entered into a definitive merger agreement with ZOLL, a manufacturer of resuscitation and critical care devices and related software solutions, pursuant to which Asahi Kasei will acquire ZOLL for approximately $2.21 billion. The transaction has been approved by the Boards of Directors of both companies.

Asahi Kasei, through a U.S. subsidiary, will make a cash tender offer to purchase all of the outstanding shares of ZOLL common stock for $93 per share. The purchase price represents a premium of 29.6% over ZOLL’s volume weighted average closing stock price over the 30 trading day period ended March 9, 2012, and a 23.8% premium over the closing price on March 9, 2012. The tender offer is expected to commence within 10 business days and will remain open for a minimum of 20 business days. Closing of the tender offer is subject to customary conditions, including receipt of applicable regulatory clearances and the minimum tender of at least two-thirds of the outstanding shares of ZOLL (on a fully diluted basis). The transaction is not subject to a financing condition. The ZOLL Board of Directors has recommended that ZOLL stockholders accept the offer and tender their shares into the offer when it is made. The transaction is expected to close in the second calendar quarter of 2012... Asahi Kasei's Press Release - ZOLL Medical's Press Release -

Boston Scientific to Acquire Cameron Health

March 8, 2012 - Company gains first and only commercially available subcutaneous ICD technology to offer lifesaving therapy to patients at risk of sudden cardiac arrest - Boston Scientific Corporation (NYSE: BSX) announces the exercise of its option to acquire Cameron Health, Inc., a privately held company based in San Clemente, California. Cameron Health has developed the world's first and only commercially available subcutaneous implantable cardioverter defibrillator – the S-ICD® System. Unlike conventional implantable cardioverter defibrillators (ICDs), which require thin, insulated wires (leads) to pass through the venous system and into the heart, the entire S-ICD System sits just below the skin and leaves the heart and blood vessels untouched. This one-of-a-kind technology has the potential to expand the reach of ICD therapy, offering physicians and appropriate patients a new alternative to traditional ICDs, while strengthening Boston Scientific's arrhythmia management portfolio.

The S-ICD System has received CE Mark and has been commercially available in select geographies, including several major European countries, since 2009. The system has been clinically evaluated in a variety of studies and has been implanted in more than 1,000 patients worldwide. Cameron Health received expedited review status and submitted its PMA application to the U.S. Food and Drug Administration (FDA) in December 2011. Boston Scientific anticipates FDA approval for the S-ICD System in the first half of 2013... Boston Scientific's press Release -

LIFEBRIDGE Medizintechnik : New ACCF/AHA/SCAI Guidelines with increased recommendations for the use of extracorporeal hemodynamic support in patients with cardiac or cardio-pulmonary failure.

January 17, 2012 - LIFEBRIDGE Medizintechnik AG announces increased recommendations for hemodynamic support by guidelines for percutaneous coronary interventions (PCI). Issued by the American College of Cardiology Foundation (ACCF), the American Heart Association (AHA) and the Society for Coronary Angiography and Interventions (SCAI), guidelines provide expanded recommendations for hemodynamic support in patients with cardiogenic shock, during high-risk PCIs and to stabilize emergent patients in hospitals without on-site cardiac surgery. The portable LIFEBRIDGEâ system, with its clinically proven capability to completely substitute cardiac function and oxygenate emergency patients, is the ideal cardiopulmonary support system for PCI centers to fulfill the updated guideline recommendations... LIFEBRIDGE Medizintechnik's Press Release -

Cellartis : partner in CardioNet, an EU-project with the aim to develop novel therapeutic tools for identification of heart disease

JANUARY 23, 2012 - Cellartis is a partner in CardioNet, an EU-project with the aim to develop novel therapeutic tools for identification of heart disease -

Enabling functional recovery of the heart after myocardial infarction through cardiac regeneration and repair is a major goal of cardiovascular and regenerative medicine. The CardioNet network, coordinated by the Spanish National Centre for Cardiovascular Research (CNIC), aims at integrating knowledge from holistic molecular and cellular biology approaches in order to better understand the regulation of heart development, homeostasis, and disease. This knowledge will contribute to the identification of new targets and the development of novel therapeutic tools for heart disease. In order to achieve these aims, a diverse interdisciplinary set of partners has been assembled comprising 13 partners throughout Europe.

About Cellectis stem cells :  Cellectis stem cells speeds up the development of stem cell technology in particular to find a robust and reproducible way of controlling stem cell production and differentiation. Through the sharing of knowledge and expertise developed by the the two companies forming Cellectis stem cells - Cellartis and Ectycell – Cellectis stem cells becomes a major, long-term and stable industrial player in the global marketplace... Cellartis' Press Release -

Ikaria : Global Registration Trial for Bioabsorbable Cardiac Matrix

Jan. 3, 2012 - PRESERVATION I Investigates Novel Device for Cardiac Remodeling and Congestive Heart Failure -

Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients in the hospital and ICU settings, announced that it has commenced its global development program, the PRESERVATION I clinical trial, for its Bioabsorbable Cardiac Matrix (BCM). The CE Mark registration trial has commenced in Australia , and will be followed in Europe. The trial also is expected to commence in other countries, including Israel.

PRESERVATION stands for A Placebo Controlled, Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction.

BCM, also known as IK-5001, is being investigated to prevent ventricular remodeling and subsequent congestive heart failure (CHF) following acute myocardial infarction (AMI). Ventricular remodeling is the structural alteration of the damaged heart muscle that occurs following an acute heart attack. Once this damage occurs, the weakened heart muscle forces the rest of the heart to compensate. Under this extra workload, the heart muscle dilates, the walls of the heart thin, and the heart further remodels, thereby causing another cycle of dilation and overcompensation. The extra workload to the heart causes further structural damage and can lead to congestive heart failure... [PDF] Ikaria's Press Release -

REVA : the RESTORE Clinical Trial First Human Implants With ReZolve(TM) Scaffold

Dec. 21, 2011 - REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") is pleased to announce that it has initiated patient enrollment in a pilot clinical study designed to evaluate its ReZolve™ Bioresorbable Sirolimus-Eluting Coronary Scaffold. The RESTORE Trial (Pilot Study of the ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold) will evaluate the safety and performance of ReZolve in 50 patients at multiple leading heart centers in Brazil and Europe.

ReZolve is a fully bioresorbable polymer scaffold designed to provide all of the proven benefits of a metal drug-eluting stent, with the advantage of dissolving from the body after it is no longer needed, leaving the patient free of a permanent implant.

The first patient implant was performed by the study's principal investigator, Dr. Alexandre Abizaid, Chief of Coronary Interventions at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil. Dr. Abizaid is a renowned interventional cardiologist and the institute is one of the world's leading heart centers.

"The procedure went very smoothly in a 90% occluded coronary artery utilizing standard practices that are used to implant conventional metallic stents around the world today. The REVA fully bioresorbable polymer scaffold deployed and became well-apposed against the artery wall and we were able to visualize the entire scaffold under standard x-ray imaging, which was very helpful," commented Dr. Abizaid. "While we will need to continue to gather data over the coming year to measure the safety and efficacy of this device, I was pleased with the outcome of today's procedure; the ReZolve scaffold delivered and deployed as designed." Dr. Abizaid also added, "Bioresorbable scaffolds represent an exciting new frontier to the treatment of coronary artery disease due to their potential to return the vessel to normal function after restoring blood flow. I am excited about the potential clinical benefits ReZolve may provide our patients and my team looks forward to enrolling additional patients in the RESTORE trial."... [PDF] REVA Medical's Press Release -

AtriCure's Synergy Ablation System : FDA Approval for the Treatment of Atrial Fibrillation

Dec 16, 2011 - First and Only System in the United States Approved to Treat Patients with Persistent and Long-Standing Persistent Atrial Fibrillation -

AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, announced that the U.S. Food and Drug Administration (FDA) has approved AtriCure's Synergy Ablation System for the treatment of atrial fibrillation (AF). Specifically, the Synergy Ablation System has been approved for the treatment of patients with persistent and long-standing persistent AF during open-heart concomitant coronary artery bypass grafting and/or valve replacement or repair procedures. This is the first time a surgical ablation system has been approved for the treatment of AF and the first time any system, catheter or surgical, has been approved in the United States for the treatment of patients with persistent and long-standing persistent AF.

"This marks the achievement of a major milestone for AtriCure, the field of cardiac surgery, and the treatment of AF. The approval confirms the effectiveness of the Synergy Ablation System and recognizes the increasing need for the surgical treatment of AF," said David J. Drachman, President and Chief Executive Officer. "We look forward to educating physicians and patients on our surgical alternative for the treatment of AF, which we believe will raise awareness for a large number of AF patients that are currently being undertreated. Importantly, we would like to thank all of our partners who worked with us to achieve this approval, particularly the FDA, physicians and their patients who participated in the ABLATE trial. Additionally, I would like to recognize the efforts of the AtriCure team, who have worked tirelessly toward the successful achievement of this seminal milestone."...AtriCure's Press Release -

BioLineRx : Initiation of CE Mark Registration Trial for BCM (BL-1040), a Novel Medical Device for Prevention of Cardiac Remodeling Following Acute Myocardial Infarction

January 3, 2011 - BioLineRx(NASDAQ:BLRX; TASE:BLRX), a biopharmaceutical development company, announced the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling following an acute myocardial infarction (AMI). The trial has commenced in Australia, will be followed in Europe, and is expected to commence in additional countries, including Israel. Ikaria Inc., which acquired the license for continuation of development and commercialization of BL-1040 from BioLineRx in July 2009, is now leading BL-1040's clinical development as Bioabsorbable Cardiac Matrix (BCM), previously named IK-5001.

PRESERVATION stands for A Placebo Controlled, Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction.

PRESERVATION I aims to evaluate the safety and effectiveness of BCM (BL-1040) for prevention of ventricular remodeling and congestive heart failure when administered following AMI. The trial is a placebo-controlled, randomized, double-blind, multi-country and multi-center trial including approximately 300 patients which are expected to be recruited across 45 sites. This includes approximately 50 Australian patients at 11 clinical trial sites. The BCM device will be administered to subjects who had successful percutaneous coronary intervention with stent placement after ST-segment elevation myocardial infarction (STEMI) and they will then be monitored for six months... BioLineRx's PressRelease -