Medtronic (NYSE:MDT) presented new data from a clinical trial of its CoreValve heart implant at the PCR London Valves 2012 meeting, showing that the direct aortic approach is feasible, and launched another trial of the transcatheter aortic valve implant.
The Fridley, Minn.-based medical device company said the 151-patient study showed 97% procedural success with no procedural deaths, a 30-day mortality rate of 8.6% and a 3.9% incidence of stroke.
Medtronic also said it’s launched the CoreValve Advance direct aortic study to examine the safety and effectiveness of the procedure.
"The growing base of evidence for direct aortic implantation with the CoreValve System shows it is a highly successful and reliable approach for many patients who have a challenging peripheral vascular system and are at high risk for open-heart surgery," Dr. Giuseppe Bruschi of the Niguarda Ca’ Granda Hospital in Milan said in prepared remarks. "These studies are enabling heart teams to collect important information about direct aortic access for the benefit of patients who need aortic valve replacement and are best suited for this increasingly common delivery option."
About 62% of patients in the feasibility study received the CoreValve implant via minithoracotomy (an opening between 2 ribs). Others received the device via ministernotomy (an opening through the sternum).
The studies are the latest in a series of trials of the CoreValve device, which won expanded CE Mark approval in the European Union last year. Medtronic is running trials to examine its use in “extreme risk” patients; lower-risk patients; and compare it with open heart surgery, among others.
And earlier this week, the smallest-size CoreValve device won CE Mark approval. Medtronic acquired CoreValve for more than $1 billion in 2009.