Medical device giant Medtronic (NYSE:MDT) released early results from the pivotal CE Mark trial of its Engager transcatheter aortic valve implantation system, touting easy deployment and fewer complications associated with the 2nd-generation device.
The new device may give Medtronic a leg up over rival TAVI-maker Edwards Lifesciences (NYSE:EW), who already won the race to the U.S. market with its Sapien valve.
The Engager system boasts some benefits over the company’s flagship CoreValve TAVI, according to researchers who presented the data during the European Assn. for Cardio-Thoracic Surgery meeting in Spain this week.
"This valve has some features that are quite different from 1st-generation devices," study presenter Dr. Hendrik Treede told Heartwire. "The most striking thing with it is the reduction in paravalvular leakage."
Valve leakage can lead to aortic regurgitation and is one of the chief challenges with TAVI technology, but one that next-generation valves are doing a better job of tackling, Treede noted.
Among the 1st 60 patients treated during Medtronic’s pivotal Engager trial, none experienced more than "trace" paravalvular leakage at 30 days, as measured by an independent echocardiography core lab, according to a press release.
Another standout result of Medtronic’s Engager trial, which launched late last year, was the flattening of the TAVI learning curve. All 60 patients received implants that were "deployed in the anatomically correct position," and there were no instances of malposition at 30 days.
There were also no procedure-related complications, no valve embolization and no coronary obstructions, Medtronic reported.
"The Engager transapical valve is designed for minimally‐invasive delivery via a catheter inserted in the apex (the lower, pointed end) of the heart," according to the company. "The valve is comprised of bovine tissue leaflets and a self‐expanding nitinol frame designed to aid in valve positioning. The valve also is designed to promote annular sealing to minimize paravalvular leak, and to provide anatomical alignment with the coronary arteries."
The news sounded similar to reports from an early feasibility study of Boston Scientific’s (NYSE:BSX) Lotus transcatheter aortic valve implantation, which also showed precise positioning on the 1st attempt and "almost compete obliteration of aortic regurgitation," according to that study’s principal investigator, Ian Meredith.
Edwards has the only TAVI approved for the U.S. market, but others are in the pipeline, including devices from St. Jude Medical (NYSE:STJ) and some from smaller, less well-known rivals
Nonetheless some analysts believe Edwards has the edge as it readies the 2nd- and 3rd-generation models of its Sapien valve and its 4th-generation Centera, which Leerink Swann healthcare investment bank analyst Danielle Antalffy sees entering clinical trials for CE Mark approval "before year-end."
St. Jude is next in line with its Portico TAVI device, with a CE Mark expected by the end of the year and a U.S. investigational device exemption trial slated to start in 2014.
Boston Scientific is developing its Lotus valve and expects to launch a CE Mark trial this week, according to Antalffy. Then there’s Direct Flow Medical and its eponymous device, expected to launch a CE Mark trial during the 1st quarter of 2013 and a U.S. IDE trial later that year.
