FDA clears CoreValve for valve-in-valve treatment

Medtronic snagged another victory for its CoreValve device with expanded FDA approval of its use in valve-in-valve procedures in inoperable and high-risk patients.

The approval applies to patients with failing surgical aortic valves that can be replaced using the transcatheter aortic valve replacement (TAVR) device. The agency approved Medtronic’s self-expanding TAVR valve in 2014 for patients with severe aortic stenosis who are at extreme and high surgical risk. In the case of the most recent approval, patients who previously were healthy enough to undergo a surgical procedure are now less robust, with valves that have deteriorated and need replacement.

“The CoreValve System offers a less invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” William Maisel, MD, deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a statement. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”

Physicians can implant CoreValve systems sized at 23mm, 26mm, 29mm and 31mm using transfemoral, subclavian and direct aortic delivery with 18Fr delivery catheter.

Medtronic has been on a roll with CoreValve. Two-year results presented March 15 at the American College of Cardiology scientific session in San Diego showed CoreValve in high-risk patients pulling ahead of standard therapy over time. At one year, the all-cause mortality rate for the TAVR group was 14.2 percent vs. 19.1 percent for the surgical group. By two years, the rate was 22.2 percent vs. 28.6 percent. TAVR achieved a 6.5 percent relative benefit over surgical aortic valve replacement.

Stroke data also showed superiority. At year one, 12.5 percent of the surgical group experienced stroke compared with 8.7 percent of the TAVR group. One year later, that gap widened to 16.6 percent vs. 10.9 percent.

The FDA determined that CoreValve valve-in-valve procedure was safe and effective based on a review of clinical data of 143 patients. The rate of survival without major stroke was 95.8 percent at 30 days and 89.3 percent at six months. According to Medtronic, results from a global valve-in-valve registry also have been favorable, with one-year survival at 89 percent.

Medtronic will assess long-term outcomes by following patients implanted with the CoreValve for valve-in-valve procedures up to five years as part of a postmarket study.