|Boston Scientific has recruited Sorin to manufacture components of the Lotus valve.--Courtesy of Boston Scientific|
Boston Scientific ($BSX) is working to join rivals Medtronic ($MDT) and Edwards Lifesciences ($EW) on the European aortic valve market, and the company has reached out to another competitor to speed its way, signing a manufacturing agreement with Sorin for the Lotus valve.
Under the deal, Sorin will manufacture components of the Lotus Aortic Valve System at its Vancouver facility, lining up support for Boston Scientific as it nears a CE mark for the device. The company hopes to win overseas approval in the fourth quarter of this year and launch Lotus in Europe shortly thereafter, a spokesman said.
While Medtronic and Edwards are reaping the spoils of increasing demand for heart valves in Europe--and repeatedly suing one another in the process--Boston Scientific believes Lotus can carve out a space of its own. In data presented at EuroPCR in May, the valve beat its performance endpoint for aortic valve pressure and met its safety goal in a study of 60 patients, posting an all-cause mortality rate of 1.7% after 30 days.
Boston Scientific plans to expand that study to 250 patients, adding those data to results from an earlier pilot trial when it applies for a CE mark.
The company acquired Lotus in its $225 million buyout of Sadra Medical back in 2010, and, under the terms of that deal, Boston Scientific owes up to $225 million if the valve meets certain regulatory and revenue milestones through 2016.
A slice of the transcatheter aortic valve boom could go a long way in helping Boston Scientific reverse its middling cardiac sales. Last quarter, the company took a $354 million loss as bearish markets for its mainstay rhythm devices outweighed growth in smaller units like neuromodulation. Interventional cardiology, which includes heart valves, took the hardest hit on the quarter, dropping 16% to $505 million in revenue.
- read Sorin's announcement
Editor's note: This story was updated to include comments from Boston Scientific.