Positive Outcomes Reported for Medtronic's CoreValve Evolut R TAVR System

March 14, 2015—Medtronic plc announced that initial clinical outcomes for its next-generation CoreValve Evolut R recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system were presented at ACC.15, the 64^th annual scientific session of the American College of Cardiology in San Diego, California.

The company reported that the CoreValve Evolut R showed no incidents of all-cause mortality or stroke in a high- and extreme-risk patient population at 30 days in the Medtronic CoreValve Evolut R CE Mark Clinical Study, which enrolled 60 patients from six centers in the United Kingdom, Australia, and New Zealand.

According to the company, the device’s new EnVeo R delivery catheter system provides a new InLine sheath that significantly reduces the profile (14-F equivalent). Transfemoral access was possible in all but one patient (98.3%) in a population that included patients with vasculature as small as 5 mm in diameter. All recapture attempts were performed safely with no strokes (0%) using the device’s new recapture capability. Additionally, correct valve position with one device was achieved in 98.3% of patients, and there were no cases of valve dysfunction, procedural death, annular rupture, coronary occlusion, valve embolization, or conversion to surgery in the study. The pacemaker rate was low at 11.7%, reported Medtronic.

Additionally, the supra-annular valve design of the CoreValve Evolut R system resulted in low, single-digit mean aortic gradients at each follow-up visit: 9.2 mm Hg in early follow-up at 24 hours to 7 days postprocedure; and 8.1 mm Hg at 30 days. The recapturable Evolut R valve features a new extended sealing skirt on the 26-mm and 29-mm sizes that further promotes valve sealing at the annulus, resulting in low rates of paravalvular leak (PVL) with ≤ mild PVL in 96.6% of patients at 30 days, noted the company.

In Medtronic’s press release, Coprincipal Investigator Ian Meredith, MD, commented, “Initial clinical experience with the Evolut R system is remarkable and ushers in a new era of TAVR technology that provides increased confidence with recapturability, excellent procedural results, and impressive clinical outcomes. The 14-F–equivalent delivery system allowed transfemoral access for most patients and the recapturable technology enabled implanters to optimize valve placement for improved annular sealing and reduced conduction disturbances without compromise on mortality or stroke.” Dr. Meredith is from Monash Heart—Monash Health in Melbourne, Australia.

The 23-mm, 26-mm, and 29-mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R delivery catheter system are available in Europe and other countries that recognize the CE Mark.

The CoreValve Evolut R system is not approved for commercial use in the United States, where it is currently undergoing clinical trials, including the Medtronic CoreValve Evolut R US clinical study, advised the company.