News

IABP, Datascope, Maquet, FDA recall

Datascope Corp./Maquet initiated a voluntary worldwide field correction of some of its intra-aortic balloon pumps (IABPs) due to a potential mechanical failure of the fan assembly associated with...

PVAD, percutaneous VAD, hemodynamic support, aortix

Percutaneous ventricular assist (pVAD) devices offer more hemodynamic support than the 40-year-old gold standard of intra-aortic balloon pumps (IABPs), but their cost and...

Sunshine Heart Inc. has launched a website dedicated to providing information to patients suffering from moderate to severe heart...

Since the 1970s, intra-aortic balloon pumps (IABPs) have been the gold standard of minimally invasive hemodynamic support, but more recently developed percutaneous ventricular assist devices (pVAD...

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...

Maquet Sensational Plus IABP

Maquet Cardiovascular received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE mark approval for its new Sensation Plus 7.5 French 40 cc...

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

September 10, 2012 — Maquet Cardiovascular LLC announced 30-day results from the large, randomized, multicenter intra-aortic...

May 16, 2012 — Maquet Cardiovascular LLC announced this week that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Mega 7.5 Fr. 30 cc and 40 cc...

March 26, 2012 — Maquet announced positive long-term mortality results from the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1), which evaluated the effect on major complications and...

Teleflex Inc. announced a new agreement with HealthTrust Purchasing Group L.P. (HealthTrust), for its Arrow Intra-Aortic Balloon Pump and Catheter products. The new agreement begins March 1, 2012...

November 11, 2011 — Maquet Cardiovascular announced U.S. Food and Drug Administration (FDA) 510(k) clearance and CE mark for its new Cardiosave intra-aortic balloon pump (IABP). The announcement...

October 17, 2011 — Maquet Cardiovascular announced it has signed a three-year, dual-source contract with Premier Healthcare Alliance to provide intra-aortic balloon pumps (IABP) to the Premier...

October 3, 2011 Maquet Cardiovascular has signed a definitive agreement to acquire Atrium Medical Corp. for $680 million. Atrium is a medical device technologies developer for...

September 20, 2011 — Maquet Cardiovascular announced it has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Sensation Plus 50 cc 8 French intra-aortic...

August 29, 2011 — Recent data suggest post-operative outcomes of severe heart failure patients bridged short-term ventricular assist devices (VADs) to urgent heart transplantation are...

Maquet Datascope CS300 Intra-Aortic Balloon Pump
June 15, 2011 – The U.S. Food and Drug Administration (FDA) said Maquet Datascope Corp. has issued a class I recall for its System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs)...
June 14, 2011 – An initial animal study of a next-generation transcutaneous C-Pulse Heart Assist System has been completed. The system is made by Sunshine Heart Inc., a global medical device company...
May 10, 2011 – The Impella percutaneously deployed ventricular assist device showed an overall average hospital charge savings when compared to the standard-of-care intra-aortic balloon pump (IABP)....

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.