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.

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.

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.

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.

Boston Scientific Corp. has announced the commencement of the use of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (TM-ICD) by European doctors. Both these cardiac rhythm management devices received the CE Mark approval in January and are awaiting approval in the US. These are among the smallest and thinnest high-energy devices in the world and offer improved battery life and self-rectifying software.