Real-World Data Presented for Medtronic's Next-Generation CoreValve Evolut R TAVR Device

October 31, 2016—Medtronic plc announced the presentation of new data from two large registries that are evaluating 30-day clinical performance outcomes for the company’s self-expanding, recapturable, and repositionable CoreValve Evolut R transcatheter aortic valve replacement system in real-world severe aortic stenosis patient populations.

Data from the Evolut R FORWARD study and the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) registry data were presented at TCT 2016, the 28^th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

According to Medtronic, the first 300 patients enrolled in the FORWARD study marks the first evaluation of the Evolut R system in routine clinical practice on a global scale.

The single-arm, prospective study is being conducted at 60 centers across Europe, Australia, the Middle East, Africa, Latin America, and Canada. The FORWARD study is designed to confirm the results achieved in the Evolut R CE study for patients with severe aortic stenosis.

The Evolut R FORWARD study demonstrated a 98% survival rate and a 3% rate of all stroke at 30-days after implantation. The study also showed improved hemodynamic performance (by mean aortic valve gradient) from 42.5 ± 17.7 mm Hg at baseline to 8.7 ± 6.9 mm Hg at discharge. Additionally, there was a 2.7% rate of major vascular complications and no reports of valve thrombosis at 30 days.

In Medtronic’s announcement, Prof. Eberhard Grube, MD, coprincipal investigator of the FORWARD study, commented, “We’re encouraged by the initial 30-day outcomes of the FORWARD study, which further showcase the advantages of the recapturable and repositionable capabilities of the Evolut R system. As patient follow-up continues at 1, 2, and 3-years postimplant, we look forward to seeing how the features of the Evolut R system can address everyday clinical needs in various severe aortic stenosis patient scenarios worldwide.”

In the analysis of 9,616 patients in the STS/ACC TVT registry, the Evolut R demonstrated 96.3% survival rate and a 3.1% rate of all stroke at 30 days with a 99% rate of successful valve implantation. Patients in this analysis also experienced improved hemodynamic performance (mean gradient: 43.7 ± 15.4 mm Hg at baseline to 8.6 ± 5.5 mm Hg at discharge) and low rates of major vascular complications (1.5%). Additionally, postprocedure hospital stays were a median of 4 days for Evolut R and 75.7% of patients treated with Evolut R returned home following discharge, as opposed to a nursing home or other rehabilitation facility, reported Medtronic.

The CoreValve Evolut R system is available in Europe and other countries that recognize the CE Mark. It was approved for commercial use in the United States in 2015.