ES Vascular has announced that it has received a CE Marking approval for its Open Aortic Stapler (OAS) system. The OAS system is to be used for mechanical suturing technology of aortic synthetic grafts during open repair of AAA and other aortic reconstructions. The approval allows commercialization of the device in most European countries.

 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.

Abiomed Inc. has received a positive national coverage determination from the Centers for Medicare & Medicaid Services (CMS) that allows coverage of the AbioCor Total Replacement Heart. The AbioCor implantable replacement heart is designed to extend the lives of patients who would otherwise die of heart failure. AbioCor can potentially offer an improved quality of life as a patient can be mobile and a productive lifestyle.

The first CryoValve SG pulmonary human heart valve, manufactured by CryoLife, has been received by the first patient. The product was approved by the FDA in February and is used in replacing the malfunctioning native pulmonary valves in patients. Children with congenital heart defects can also receive the valve for right ventricular outflow tract reconstruction procedures.

Japan’s Ministry of Health, Labor and Welfare has granted regulatory approval to St. Jude Medical for its SJM Tailor flexible ring and band. These products are used to repair damaged mitral and tricuspid heart valves in the heart. These are the company’s first heart valve products being released in Japan and already have approval in the U.S. and Europe.