Medtronic (NYSE:MDT) reported positive data from a study evaluating the safety and effectiveness of implanting its CoreValve aortic valve-replacement device via a catheter inserted through the ribs rather than into a vein in the upper leg.
The cardiac device giant is testing the procedure as an alternative for patients with severe aortic stenosis who are not suitable candidates for the leg-catheterization procedure due to conditions such as heavy vascular calcification, peripheral artery disease or small iliofemoral blood-vessel diameter.
The Advance DA study enrolled 100 patients across 9 European centers, following them for 1 year. Patients showed low rates of mortality, stroke and paravalvular leak at 30 days, Medtronic said, along with what the company said were significant improvements of heart-failure symptoms and quality of life.
Researchers presented the data at the annual meeting of European Assn. for Cardio-Thoracic Surgery in Milan.
The CoreValve system is a heart valve replacement device consisting of tissue derived from pig hearts and a flexible, self-expanding frame for support. The replacement valve is inserted in patients through a catheter. Medtronic has touted CoreValve as a less invasive alternative to traditional valve-replacement procedures that require open-heart surgery.
Since receiving CE Mark clearance in 2007, the CoreValve system has been implanted in more than 65,000 patients globally. The product is also approved by the FDA for patients at high-risk for undergoing surgery, according to the company.
In a CoreValve guide for patients, Medtronic notes that physicians can implant the device via the femoral artery in the leg, subclavian artery in the neck or the direct aortic approach through a space between the ribs, with the last option considered the most invasive.
Last May, Medtronic and rival Edwards Lifesciences (NYSE:EW) agreed to settle litigation over CoreValve. Under the agreement, Edwards dropped an injunction that prevented Medtronic from selling the product in the U.S. In return, Medtronic will make a one-time payment of $750 million, on top of royalty payments of at least $40 million a year through April 2022.
In an August conference call, a Medtronic executive said the company has seen immediate demand for CoreValve.
"It’s been challenging for our operations in the group to stay ahead of the demand, but they have been doing that," said Mike Coyle, president of Medtronic’s cardiac and vascular group, on the call. "We are essentially selling as we implant and we expected that will continue."