The FDA approved Medtronic’s CoreValve Evolut R device on June 23, giving physicians in the U.S. who perform transcatheter aortic valve replacement (TAVR) procedures the ability to recapture and reposition a valve during implantation.
The Evolut R is Medtronic’s new-generation device for treating patients with severe aortic stenosis. Like the other self-expanding CoreValve devices, it has been approved for use in patients at high or extreme operative risk. The approval covers the CoreValve EnVeo R Delivery Catheter System and valves in 23 mm, 26 mm and 29 mm sizes.
The CoreValve Evolut R has a lower-profile delivery system and features that are intended to reduce paravalvular leak and other complications. The 26mm and 29mm valve sizes offer an extended sealing skirt with a scalloped design that is expected to promote valve sealing.
In addition, the ability to accurately place the valve using the recapturing-repositioning option is expected to reduce the need for permanent pacemakers. In the pivotal CoreValve trials, the need for a permanent pacemaker was 21.6 percent in extreme-risk patients at 30 days and 19.8 percent in high-risk patients.
In the CoreValve Evolut R CE Mark study in Europe, the 30-day permanent pacemaker rate was 11.7 percent, with correct positioning in 59 of 60 implantations, according to conference presentations. At 30 days, almost 97 percent of patients had no or mild paravalvular leak, and no patient had severe paravalvular leak. The 14 Fr equivalent delivery system and three valve sizes received CE mark in February 2015.
The CoreValve devices and Edwards Lifesciences’ Sapien balloon-expandable TAVR systems are the only two TAVR valves to date approved by the FDA.
Several companies have launched trials to assess the safety and efficacy of other devices, many with retrievable and repositionable features. Those include Boston Scientific, with its preloaded and stent-mounted Lotus valve; Direct Flow Medical, with a double-ring design; and St. Jude Medical, which paused a trial for its self-expanding Portico system to investigate reports of leaflet motion. The FDA gave the trial the go-ahead to resume this month.