Both major percutaneous-valve makers announced regulatory progress for their respective technology platforms.

Irvine, CA and Minneapolis, MN --The Food and Drug Administration conditionally approved Edwards's plan to add a second treatment group to its PARTNER II trial, of the Sapien XT transcatheter aortic heart valve. The new wing of the study, called cohort A, will be a noninferiority comparison in up to 2000 patients with severe, symptomatic aortic-valve stenosis and an "elevated" risk for traditional open-heart surgery, defined as a Society of Thoracic Surgeons score greater than 4. These patients are lower risk than those who were enrolled in the PARTNER trial.

The patients will be randomized 1:1 to either transcatheter valve or surgical valve replacement. The transcatheter patients will undergo either a transfemoral procedure or a transapical valve implant. The primary end point of the study is a composite of death and major stroke at two years. The company hopes to finish enrollment of the first cohort in PARTNER II, cohort B, by the end of the year.

On the same day, Medtronic announced it received CE Mark approval to market its CoreValve percutaneous aortic valve to be delivered through direct aortic access in patients unsuitable for other approaches because they have small vessels. Direct aortic access can be created either with a minithoracotomy in the second intercostal space or an upper hemisternotomy, the company said.

Medtronic boasts that CoreValve is the only transcatheter aortic-valve implantation system approved for direct aortic or subclavian implantation as well as the more common transfemoral approach. The direct aortic approach requires a minimally invasive procedure on a beating heart and does not require any cut through the ventricular wall or pericardium, and early tests suggest the direct aortic approach is as safe and effective as the transfemoral and subclavian approaches. The company believes the direct aortic approach may allow the surgeon to handle and position the valve more easily than with the other approaches.

The direct aortic procedures are also being tested in the CoreValve US pivotal trial, the company says.

Source: Heartwire, theheart.org