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 -