It's a crowded market for transcatheter aortic devices, and Boston Scientific ($BSX) is trying to get a leg up on the competition. The company is celebrating positive study results for its transcatheter aortic valve replacement, touting data it hopes will set it apart from its market rivals.
The Natick, MA-based company presented favorable clinical trial results for its Lotus transcatheter aortic valve replacement (TAVR) system over the weekend at the American College of Cardiology's annual scientific meeting in Washington, DC. Data was collected from an ongoing, single-arm study of the device, Reprise II, which found that 85% of patients had no paravalvular aortic regurgitation after being outfitted with the valve.
The study includes 120 patients at 14 sites in Australia, France, Germany and the U.K., and an additional 130 patients will be enrolled in an extension study at 16 sites in Australia and Europe. Enrollment in the extension study is slated for completion in April 2014, the company said in a statement.
Competitors Medtronic ($MDT) and Edwards Lifesciences ($EW) are developing their own transcatheter valve systems. In a recent head-to-head study of the two firms' competing TAVR devices, Edwards' Sapien XT valve replacement demonstrated a 95.9% success rate, compared with a 77.5% success rate for Medtronic's CoreValve product. Both devices were developed to treat aortic stenosis--a $3 billion market with 300,000 patients worldwide, according to Bloomberg and analyst estimates.
Positive numbers move Boston Scientific one step closer to obtaining coveted U.S. regulatory clearance for its transcatheter implant. In October 2013, Boston Scientific won a CE mark for its Lotus device, moving the company into a saturated European market. Medtronic's CoreValve won FDA approval in January in patients for whom surgery present an extreme risk, while Edwards' Sapien XT device awaits U.S. approval, Bloomberg reported.
A transcatheter valve is not the only product Boston Scientific has in its arsenal: The company also presented favorable study results for its cardiac resynchronization therapy (CRT) and platinum bare metal stents at last weekend's cardiology conference. In a long-term follow-up study of its CRT defibrillator for patients with mild heart failure, results demonstrated a 41% decrease in the risk of death in patients who received the CRT product, compared to those who received the defibrillator alone.
Another trial compared the company's Platinum coronary stent system with Abbott Laboratories' ($ABT) drug-eluting stent. Results showed the long-term efficacy of Boston Scientific's stent system, with clear advantages over Abbott's product, the company said in a statement.
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