News

July 19, 2011 — An article published in the July issue of the Journal of Heart and Lung Transplantation reports the first use of the Freedom portable driver with a Total Artificial Heart...

July 13, 2011 – The TandemHeart circulatory support system has been granted expanded reimbursement coverage by NHIC Corp., the medicare administrative contractor (MAC) serving over 1.3 million...
June 30, 2011 — Results of a clinical research study at Sharp Memorial Hospital indicate that patients 70 years of age or older have good functional recovery, survival and quality of life at two...
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)....
May 3, 2011 – The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Maquet Cardiovascular’s Cardiohelp system as a cardiac and/or respiratory assist device for up to six hours....

April 19, 2011 – Promising new devices for mechanical circulatory support of children with heart defects or heart failure, and related research, will be revealed this week at the International...

April 13, 2011 – The American College of Cardiology Foundation (ACCF), American Heart Association (AHA) and the Heart Failure Society of America (HFSA) have released results of a recent survey to...

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.

March 28, 2011 – The Therapeutic Goods Administration (TGA) of Australia has approved the HeartWare Ventricular Assist System for listing on the Australian Register of Therapeutic Goods (ARTG).

March 11, 2011 – Texas Children's has become the world's first pediatric hospital to complete the first phase of certification to implant the SynCardia temporary Total Artificial Heart. The...

February 17, 2011 – On Jan. 15, after 864 days of life with an artificial heart, Charles Okeke received a dual heart and kidney transplant at the Mayo Clinic Hospital in Phoenix. Okeke had been...

January 27, 2011 – The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) Supplement allowing more patients to participate in the ADVANCE trial. The...

January 26, 2011 - The University of Michigan Cardiovascular Center and the University of Pittsburgh have been awarded $13.3 million to explore the potential benefits of heart devices for the...

January 13, 2011 – HeartWare International has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for its ventricular assist system. The system acts as a...

January 3, 2011 – Arrow International, a division of Teleflex Medical, issued a class I recall, advising customers to immediately discontinue use of its Ultra 8 French intra-aortic balloon pump (...

December 7, 2010 – A study comparing a transcatheter ventricular assist device (VAD) to intra-aortic balloon pumps (IABP) has been completed after interim analysis determined the primary endpoint...

December 6, 2010 – The U.S. Food and Drug Administration (FDA) has given conditional approval for a trial that will investigate the role of a device in reducing infarct size in patients with ST-...

November 17, 2010 – Data from the ADVANCE bridge-to-heart-transplant study showed that 92 percent of patients were either alive on the implanted device, had a heart transplant or explanted for...