The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Cardica, Inc. to market its PAS-Port(R) Proximal Anastomosis System for use in cardiac bypass surgery. The system creates a safe connection (anastomosis) between a vein graft and the aorta (the main artery in the human body) during coronary artery bypass grafting (CABG) procedures. The current method requires that the aorta be clamped which leads to the release of tiny blood clots or particles from it. These can reach the brain and cause stroke and other neurological complications.

The U.S. Food and Drug Administration (FDA) has approved the Carpentier-Edwards PERIMOUNT Magna mitral heart valve. This has allowed the Edwards Lifesciences Corporation, the world leader in the science of heart valves to launch the product in the United States. The valve is a pericardial tissue-based bioprosthetic device designed for the treatment of mitral valve disease. The PERIMOUNT Magna mitral valve provides patients and surgeons with an important option for mitral valve replacement with features like asymmetric shape, low profile and expansive sewing cuff.

 CorMatrix Cardiovascular Inc. has received 510(k) clearance from the FDA for its CorMatrix ECM(TM) for Cardiac Tissue Repair, which utilizes the company’s proprietary ECM Technology(TM). The company’s platform ECM Technology provides a natural bioscaffold that enables a patient’s own host cells to repopulate and repair damaged tissues. The CorMatrix ECM, which is currently cleared for the reconstruction and repair of the pericardium, can now be used for suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects.

Thoratec Corporation has received FDA approval for its PMA (PreMarket Approval) application, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure. The system supports the weakened heart of younger adults who are at risk of dying while awaiting a heart transplant.

The FDA has approved Life Recovery Systems’ Investigational Device Exemption (IDE) application to investigate rapid hypothermia treatment in combination with primary angioplasty to treat heart attacks. The patients enrolled in the study will be given hypothermia along with Life Recovery Systems ThermoSuit(R) non-invasive cooling system. The patients will undergo cooling in the emergency room within one hour of their arrival and the door-to-balloon time will not extend beyond 90 minutes.

The FDA has decided to continue to regulate Vasogen’s Celacade system as a medical device. The Celacade system is a treatment for patients with New York Heart Association (NYHA) Class II heart failure. The FDA’s Center for Biologics Evaluation and Research (CBER) is to take over as the lead reviewer of the programme. The CBER has informed Vasogen that it does not agree with the use of a Bayesian approach in the ACCLAIM II study of the system. The FDA had earlier recommended the design.