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Boston Scientific’s Lotus Edge Valve System Gets Approval in Europe

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Overview

Boston Scientific (BSX) is consistently working towards gaining higher market share in the attractive TAVR (transcatheter aortic valve replacement) market in Europe and is set to enter the US TAVR market in 2017. On September 19, 2016, Boston Scientific received CE marking for its Lotus Edge valve system. The predecessor Lotus Valve System product got CE marking in 2013 and is one of the leading TAVR systems in Europe.

TAVR is used for the treatment of patients suffering from advanced cardiovascular diseases. It’s a minimally invasive surgical procedure that doesn’t require an open heart surgery and replaces the aortic valve with an artificial valve using catheters in blood vessels.

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TAVR systems form part of Boston Scientific’s structural heart therapies, which are offered by the company’s interventional cardiology segment. Boston Scientific’s interventional cardiology business grew approximately 12% in 2Q16, led by its structural heart and DES (drug-eluting stents) sales. For more detail on Boston Scientific’s fiscal 2Q16 earnings, check out Boston Scientific Beats Earnings Estimates, Ups Guidance.

Lotus Edge valve system’s features and benefits

The Lotus Edge valve system consists of a more flexible and lower profile catheter as compared to Lotus valve systems, which makes it easier to use. The device also includes Depth Guard technology, which helps reduce the requirement of a permanent pacemaker.

According to Boston Scientific, “Leveraging the current Lotus platform, the LOTUS Edge valve system integrates the Adaptive Seal technology which minimizes paravalvular regurgitation (leaking) or PVL, as demonstrated in the 1,000 patient RESPOND Post-Market Registry. This study found that 91.9% of patients had core-lab adjudicated trace or no PVL pre-discharge, and 7.7% had mild PVL. No patients had severe PVL and only 0.3% of patients had moderate PVL.”

Medtronic (MDT), Edwards Lifesciences (EW), and St. Jude Medical (STJ) are Boston Scientific’s major competitors in the TAVR market. The iShares Russell 1000 ETF (IWB) has ~0.15% of its total holdings in Boston Scientific.

Next, we’ll discuss the FDA approval of Boston Scientific’s Emblem MRI S-ICD System.

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