The FDA has approved the use of CoreValve for aortic valve-in-valve replacement procedures, meaning that the transcatheter aortic valve implantation (TAVI) device is now the first such device to be approved for valve-in-valve procedures in the USA both for patients who are high risk and for those who are at extreme risk. The device is already approved as an alternative to surgery, for first-time procedures, for patients who are high or extreme risk.
During the valve-in-valve procedure, the CoreValve System is placed inside a failing surgical heart valve with an inner diameter from 17–29mm through a low-profile, 18Fr delivery catheter, which is approved for use with all four CoreValve sizes (23mm, 26mm, 29mm and 31mm), as well as three delivery approaches (transfemoral, subclavian and direct aortic).
A press release reports that the CoreValve system is engineered with a supra-annular valve design, which helps maximise blood flow for patients whose artificial heart valves have shown either stenosis, regurgitation, or both. Outcomes from an Expanded Use Study, an observational arm of the CoreValve US Pivotal Trial, demonstrated low rates of mortality and stroke (for a combined rate of 4.2% at 30 days and 10.7% at six months) and significant improvements in haemodynamics and quality of life in patients with failed surgical heart valves. Results from the largest global VIV registry also showed the valve-in-valve approach resulted in considerable haemodynamic improvements, including a decrease in blood flow resistance. In this registry, positive procedural outcomes were maintained at one year follow-up with 89% survival, which was comparable with other non-valve-in-valve TAVI studies.
“This first-of-its-kind FDA approval showcases Medtronic’s commitment to advancing the TAVI field so that more patients can receive access to this life-saving, minimally invasive therapy,” says Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, which is part of the Cardiac and Vascular Group at Medtronic. “The CoreValve design is uniquely suited for valve-in-valve implantation due to its supra-annular design. We are pleased to be able to provide physicians and patients with another treatment option to replace surgical heart valves when needed.”