Medtronic Reports on Studies of Direct Aortic Implantation of CoreValve System

October 2, 2012—Medtronic, Inc. (Minneapolis, MN) reported two clinical research updates related to the Medtronic CoreValve system used with a direct aortic implantation approach. The company received CE Mark approval in November 2011 for the CoreValve system to be delivered by direct aortic access in patients with severe aortic stenosis.

According to the company, data presented at the PCR London Valves 2012 meeting confirm that direct aortic implantation of the CoreValve system is a feasible option for patients. The data from 151 patients showed a 97% procedural success rate at 15 centers across Europe and Israel. There were no procedural deaths, the overall 30-day mortality rate was 8.6%, and the incidence of stroke was 3.9%.

Medtronic noted in its press release that in the multicenter experience reported at the PCR London Valves meeting, approximately 62% of the patients received the replacement valve through a minithoracotomy, and other patients received the valve through a ministernotomy; both procedures are minimally invasive and are performed without stopping the heart or penetrating the heart's ventricular wall. Most patients (86%) in the study had peripheral vascular disease, and the mean logistic EuroSCORE was 26.6 ± 16.

Medtronic also announced the start of the international CoreValve ADVANCE Direct Aortic study. The direct aortic approach also is being evaluated in the Medtronic CoreValve United States Pivotal Trial. The CoreValve system is currently limited to investigational use in the United States, advised the company.

“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,” commented Giuseppe Bruschi, MD, who serves as Coprimary Investigator in the ADVANCE Direct Aortic study. “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.”