Medtronic's CoreValve Evolut R 34 mm valve, which already has FDA approval, has secured CE Mark, enabling minimally invasive treatment for a large portion of aortic stenosis patients.

Medtronic announced another regulatory win for its largest size transcatheter aortic valve, the CoreValve Evolut R 34 mm valve, which has just received CE Mark. The 34 mm valve will be the largest transcatheter aortic valve commercially available in Europe.

The CoreValve Evolut R 34 mm valve received FDA approval for high- and extreme-risk patients in October 2016, earlier than expected. Like the U.S. approval, having CE Mark gives Medtronic the ability to commercialize a minimally invasive treatment option for a significant group of severe aortic stenosis patients who haven't had the option of a transcatheter aortic valve replacement (TAVR) before.

"It's important that patients with large aortic root anatomies can also have access to this recapturable TAVI system, which has proven to be an excellent treatment option for many patients," Darren Mylotte, MD, interventional cardiologist at the University Hospitals and National University of Ireland in Galway, Ireland, said in the release. "Consistent with the Evolut R platform, the 34 mm valve delivery system assists with accurate placement with the option to recapture and reposition if needed; this gives physicians great confidence that exceptional outcomes can be achieved for our patients."The device is intended to treat patients with severe aortic stenosis who are at extreme, high, or intermediate risk of surgery. The valve size is designed to fit patients with a valve annulus of 26-30 mm. According to the Medtronic press release, this corresponds to approximately 20-25% of the European patient population.

The FDA approval for CoreValve Evolut R 34 mm is expected to boost U.S. sales growth for Medtronic. Omar Ishrak, Medtronic chairman and CEO, said on the company's November 2016 earnings call, "For example, in the fast growing TAVR market, we lacked until recently, a large sized version of our Evolut R platform . . . However, at the end of this quarter, we did receive FDA approval for Evolut R XL, which we expect to drive U.S. growth in the back half of our fiscal year."

Rhonda Robb, vice president and general manager of the Heart Valve Therapies business at Medtronic said in the release, "We look forward to working with physicians across Europe to offer this highly anticipated valve size to the thousands of patients who were previously unable to receive TAVI due to valve size."

[Image courtesy of MEDTRONIC]