Articles

 The U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the HeartWare Ventricular Assist System (VAS) designed as a bridge to cardiac transplantation.

FDA Intra-Aortic Balloon Pumps

November 8, 2012 — A U.S. Food and Drug Administration (FDA) advisory committee is meeting Dec. 5 to discuss how to classify and regulate...

Abiomed Impella CP VAD

Abiomed Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella ventricular assist device (VAD) providing...

September 11, 2012 — Primary results from an ongoing trial by Maquet Cardiovascular using intra-aortic balloon pumps (IABP...

Jarvik Heart Inc. announced conditional U.S. Food and Drug Administration (FDA) approval of its pivotal trial for evaluation of the Jarvik 2000 heart for destination therapy (DT). Use of the...

SynCardia Total Artificial Heart patient Jack Miller was able to enjoy Christmas

Jack Miller, 62, is probably the only politician in America who smiles when people call him “heartless.” Four months ago, doctors at Virginia Commonwealth University (VCU) Medical Center in...

September 1, 2011 – Mechanical pumps to give failing hearts a boost were originally developed as temporary measures for patients awaiting a heart transplant. But as the technology has improved,...

August 3, 2011 — Texas Children's Hospital (TCH) is the nation's first pediatric hospital to both surgically implant and later explant a mechanical ventricular assist device (VAD) inside the chest...

A transcatheter ventricular assist device performed better than intra-aortic balloon pumps (IABP), with a 21 percent reduction in major adverse events at 90 days.

The femoral artery approach for cardiac catheterizations has been used as the gold-standard in the United States, but there is growing interest in the transradial approach. One of the main...