Boston Scientific bags CE mark for heart valve as market crowds

Boston Scientific won a CE mark for its Lotus valve.--Courtesy of Boston Scientific

Boston Scientific ($BSX), the latest entrant into the transcatheter valve replacement space, has won a CE mark for its Lotus implant, nudging the company into an overseas market headlined by squabbles between Edwards Lifesciences ($EW) and Medtronic ($MDT).

The company touts Lotus as easier to position than its competitors, saying it's the only TAVR device that can be assessed in its final position before it's released, allowing surgeons to resheath and retrieve the implant in the middle of a procedure. In 6-month data released last month, patients demonstrated healthy rates of mean aortic valve pressure and charted low rates of paravalvular regurgitation, in which blood leaks from between the implant and cardiac tissues.

Now, Boston Scientific faces the uphill battle of competing with Edwards and its market-leading Sapien valves, not to mention Medtronic, which is gaining steam with its CoreValve and Engager devices, and 2013 Fierce 15 winner JenaValve, which has a boatload of VC cash to expand European adoption of its novel implant.

But the Massachusetts device giant is confident Lotus can carve out a space for itself in the market, Boston Scientific Structural Heart President Tom Fleming said, thanks in part to the implant's proprietary Adaptive Seal technology, which helps minimize paravalvular leakage.

"The Lotus valve system offers patients a new, effective treatment option and provides physicians unmatched positioning and placement capabilities," Fleming said in a statement. "It's the culmination of a decade of research and development and demonstrates our commitment to innovations that make a difference in the lives of patients."

Lotus is front and center among a spate of new technologies Boston Scientific is counting on to help right the ship of revenue. Adding a TAVI implant to the clot-busting Watchman and some new electrophysiology devices hauled in through M&A, the company is looking to diversify its products as it pursues sizable cuts to tamp down costs. This month, Boston Scientific announced plans to cut as many as 1,300 more jobs around the globe to save as much as $200 million a year.

- read the statement

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