Boston Scientific’s (NYSE:BSX) Lotus transcatheter aortic valve implantation system fared well in an early feasibility study in patients with severe symptomatic aortic stenosis who were to sick to undergo open-heart surgery.
The Lotus system, designed to minimize valve leakage post-implant, was implanted in 11 patients at 3 Australian sites, with 1 incident of major in-hospital adverse cardiovascular or cerebrovascular event, 1 stroke and no deaths in the Reprise 1 trial. No moderate or severe leakage was seen after the valve placement or at patient discharge from the hospital.
The Lotus device, which Boston Scientific acquired in the 2011 with the $450 million buyout of Sadra Medical, is designed to minimize valve leakage post-implantation, according to a press release.
"Perhaps the most impressive feature of the Lotus Valve System in this study was the ability to precisely position the valve on the first attempt, eliminating the need for repositioning, although this capability was available if needed," principal investigator Ian Meredith said in prepared remarks. "Another striking feature was that the valve operated early in the deployment process, providing us some comfort and time to consider the valve position, as well as the immediate and almost complete obliteration of aortic regurgitation even in patients who had moderately severe aortic regurgitation after balloon valvuloplasty. In this regard, I think the Lotus valve technology is somewhat unique."
The Reprise II trial, which will be used to support a bid for CE Mark, will include about 120 patients at 15 sites. Enrollment is expected to close in the 1st half of 2013, according to the release.
Sapien landed FDA clearance in November 2011 for treatments of patients too sick to undergo open-heart surgery. Medtronic’s CoreValve TAVI system won CE Mark approval in the European Union in March 2007, and is expected to hit the U.S. market in 2014.