Thoratec Corp. received FDA approval of 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.

Vascular Insights received 510(k) clearance from the FDA to market its ClariVein infusion catheter for infusion of physician-specified agents in the peripheral vasculature. ClariVein is a percutaneous, 2 2/3 Fr (0.035-inch) catheter, containing a rotating wire driven by a motor, that enhances fluid dispersion in the treatment area.

The Abiomed Inc. Impella 2.5 cardiac assist device was FDA cleared in 2008 for use for partial circulatory support for periods up to six hours. The intra-aortic balloon pump (IABP) also has 510(k) clearance and approximately 110,000 are used each year in the U.S.

The Sorin Group said the FDA approved to market the CRT model of its OVATIO family, reportedly the smallest CRT defibrillator (CRT-D) available. The OVATIO CRT 6750 is shaped to offer ease of implantation and long-term patient comfort, and is designed to allow more flexibility in the management of cardiac resynchronization and antitachyarrhythmia therapy due to its Brady-Tachy Overlap (BTO).