News

Terumo Coronary Ostia Cannula
June 15, 2011 – The U.S. Food and Drug Administration (FDA) said Terumo Cardiovascular Systems Corp. has issued a class I recall for its Coronary Ostia Cannula 10 (25 cm) long. The company said...
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...
June 6, 2011 – AngioDynamics has expanded its VenaCure EVLT System product offering with the global launch of the new VenaCure 1470nm laser to treat varicose veins with greater energy efficiency.
June 3, 2011 -- Maquet Cardiovascular announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its CardioRoot aortic graft in the United States. A...
May 23, 2011 -- Boston Scientific Corporation announced results from a clinical study evaluating the use of its Watchman Left Atrial Appendage Closure Device in patients with atrial fibrillation who...
May 18, 2011 - Jasbir Sra, M.D., and Tanvir Bajwa, M.D., are the first in Wisconsin to implant a new device in a patient’s heart that may reduce strokes in individuals suffering from atrial...
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 22, 2011 – A new study found that coronary artery bypass surgery added to medical therapy for selected chronic heart failure patients offered benefits over medical therapy alone.

April 22, 2011 – The U.S. Food and Drug Administration (FDA) has cleared the Trifecta valve, by St. Jude Medical. The valve, a clinically-proven replacement for diseased, damaged or malfunctioning...

April 8, 2011 – In the largest randomized, multicenter trial to compare drug-eluting stents (DES) and bare-metal stents (BMS) placed in saphenous vein graft lesions, researchers found that DES led...

The transcatheter MitraClip mitral valve repair system continues to compare favorably with conventional open-heart surgery for treatment of select patients with mitral regurgitation. The findings...

April 8, 2011 — A study from a South Korean research team found that angioplasty with a sirolimus-eluting stent was non-inferior to coronary artery bypass surgery (CABG) in patients with...

The U.S. Food and Drug Administration (FDA) this week released its February list of device and technology premarket approvals (PMA), product development protocols (PDP), supplement and notice...

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 31, 2011 – Accurately navigating and interpreting cardiovascular anatomy for precise device deployment is a challenge to physicians during complex interventional procedures. In order to help...

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 28, 2011 – Patients who have suffered a "mini stroke" are at twice the risk of heart attack than the general population, according to research reported in Stroke: Journal of the...

March 22, 2011 - Terumo Cardiovascular Systems (CVS) said it agreed to the terms of a consent decree with the U.S. Food and Drug Administration (FDA) regarding quality system improvements at the...