Medtronic, a medical device company, has obtained the US Food and Drug Administration (FDA) approval for its CoreValve self-expanding transcatheter system.
The device is designed for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery.
Based on the clinical data from the Extreme Risk Study of the CoreValve US pivotal trial, the FDA has approved the device without an independent device advisory panel review.
The study showed that the CoreValve system is safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported.
This study met its primary endpoint of death or major stroke at one year with a rate of 25.5%, which was 40.7% lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA).
The rate of stroke at one month was 2.4% and it remained low over time with a one-year rate of 4.1%. In addition, 75.6% of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the US pivotal trial, demonstrated even better survival and stroke performance.
Medtronic senior vice president and Medtronic Structural Heart Business president Dr John Liddicoat noted the FDA approval of CoreValve system is important for US heart teams as the device will serve the broadest spectrum of aortic stenosis patients who are unable to undergo surgery.
"By leveraging Medtronic's history and expertise in bringing therapies to patients, we are supporting heart teams through training and education, imaging and patient evaluation programs that exemplify our safe and deliberate approach to patient access," Dr Liddicoat added.
The CoreValve system obtained CE Mark approval in 2007. The self-expanding aortic valve serves broad spectrum of potential transcatheter aortic valve replacement patients who are unable to undergo surgery.
The device features self-expanding nitinol frame which enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.
