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.

TRUMPF Medical Systems Inc. offers an in-light high definition (HD) operating room camera, the TruVidia HD, which captures and transmits razor sharp, true-to-life images. The camera offers a 1,080 line horizontal resolution and 2 million pixels. The images are said to be more than twice as clear as those available from standard definition cameras.