WASHINGTON, March 29 (Reuters) - Medtronic Inc’s minimally invasive CoreValve system for replacing diseased aortic heart valves led to a significantly higher survival rate after one year than traditional open heart surgery in patients deemed at high risk of death during surgery, according to data from a study presented on Saturday.
One year after receiving the CoreValve in the 795-patient Phase III trial, the rate of death was 14.2 percent compared with a 19.1 percent death rate in the surgery group, researchers said. The result, presented at the American College of Cardiology scientific meeting in Washington, was deemed to be statistically significant.
There was also no increased risk of stroke seen with CoreValve compared with surgery, which had been one of the main concerns of transcatheter aortic valve replacement (TAVR) early on in clinical testing.
“I think the results were outstanding,” said Dr. David Adams, a co-principal investigator of the CoreValve trial.
TAVR systems use a catheter threaded through an artery to the heart to put the new valve in place, sparing patients chest cracking open heart surgery and typically longer hospital stays associated with the invasive surgical procedure. (Reporting by Bill Berkrot and Ransdell Pierson; Editing by Elaine Hardcastle)