Medtronic today presented findings from a European trial testing the effectiveness of the CoreValve ReValving system, a percutaneous aortic stenosis repair device, in a subclavian approach for people who were at risk if the femoral approach would have been used. Medtronic has acquired the Irvine, California based CoreValve, Inc. in March of this year, and is now moving full steam ahead to implement this nitinol-based stent device for clinical settings.
The data reported procedural success of 100 percent; 24-hour survival of 100 percent; and 30-day survival of 89 percent. The available 30-day analysis also demonstrated clinical improvement in heart failure symptoms with 76 percent of the patients gaining at least a one-stage NYHA class and one-third improving by at least two stages.
Medtronic’s market-leading CoreValve system was designed to allow the implant of a replacement heart valve in patients with aortic stenosis who are at high or prohibitive surgical risk. The system enables a catheter-based implant via a peripheral blood vessel, traditionally the femoral artery. A significant subset of patients, however, have compromised peripheral arteries, which prevents the use of the femoral approach. Uniquely, the delivery system of the CoreValve device is small enough to allow an alternative approach via the subclavian artery beneath the collar bone.
The data presented today at the PCR interventional cardiology meeting in Barcelona reported on data from 74 patients for whom subclavian access was used within the CoreValve Extended Evaluation Registry, an observational study which closed in January 2009. The average age of the patients was 81.4. Moreover, the average Logistic EuroSCORE (a measure which predicts risk of procedural mortality based upon patient status) was notably high at 28.4%.
Press release: Medtronic’s CoreValve Shows Subclavian Access Success in Patients Contraindicated for Femoral Approach
Product page: CoreValve ReValving…
Animation below the fold demonstrating the implantation of the CoreValve: