Medtronic has announced the US Food and Drug Administration (FDA) approval and US launch of the CoreValve Evolut R 34mm valve.
CoreValve Evolut R 34mm valve is claimed to be the largest sized transcatheter aortic valve replacement (TAVR) system available in the US.
The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at either high or extreme risk for surgery with an annulus size ranging from 26-30mm.
This valve segment is estimated to account for approximately 25-30% of the eligible global TAVR patient population.
Earlier, some of the patients were unable to receive a TAVR due to the larger size of their native diseased aortic valve.
NYU Langone Medical Center in New York City chief of adult cardiac surgery and director of Interventional Cardiology and the Heart Valve Program and co-primary investigator for the Evolut 34mm clinical study Mathew Williams said: "We're pleased to have more options to offer patients suffering from severe aortic stenosis who are at high risk or unable to have open-heart surgery.
"This new, larger valve offers patients with larger anatomical structures access to TAVR.
For physicians, the recapturable and repositionable Evolut R can lead to increased accuracy in placement and control during the procedure."
The Evolut R 34mm valve is delivered through the EnVeo R Delivery Catheter System, which comes with an InLine Sheath.
This system is claimed to deliver the lowest, true delivery profile currently on the market (16 Fr equivalent, approximately 1/5 inch), which offers a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route.
The Evolut R System, with its self-expanding nitinol frame, is intended to fit within the native aortic valve, using its supra-annular valve position to help achieve hemodynamic performance.
Medtronic cardiac and vascular group heart valve therapies business vice-president and general manager Rhonda Robb said: "Heart teams can now use the Evolut R platform to treat the broadest annulus range in the US market.
“The approval of the 34mm valve expands the patient population that can now receive this minimally invasive treatment alternative to open heart surgery.
"We look forward to working with physicians and heart teams across the US to provide this valve to the many patients who need it."