Global medical device maker Boston Scientific (NYSE:BSX) initiated an observational post-market study last week, called the RESPOND Registry, to assess the performance and clinical outcomes of its Lotus Transcatheter Aortic Valve (TAVR) system. The RESPOND Registry will collect performance data of the company’s Lotus TAVR system implanted in 1,000 patients across 50 centers globally.  This post-market study follows the successful completion of its REPRISE II clinical trial, which reported strong performance results for the TAVR system in terms of safety and efficacy at six months, according to data presented by the company at EuroPCR 2014 in Paris last month. 
The Lotus TAVR device is used to replace impaired heart valves (aortic stenosis) in patients who are too weak for traditional open heart surgery. Boston Scientific received CE approval – approval to be sold within the European Economic Area – for the device in Q4 2013 and it is part of the company’s Interventional Cardiology (IC) division, contributing to sales of the Structural Heart business. In the past few years, IC sales have declined rapidly owing to macroeconomic headwinds and increasing competition. However, the business is turning around on account of improving economic conditions and growing acceptance of new products. In the first quarter this year, IC sales grew by a modest 1% year-over-year on a constant currency basis, to about $500 million. 
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The Lotus TAVR system reported solid uptake in Q1 this year and positive results from the RESPOND Registry could further aid its acceptance in international markets and drive IC sales going forward. The company also expects to start IDE trials for the Lotus device in the U.S. later this year. 
We have a price estimate of $13 for Boston Scientific, which is in line with the current market price.Notes: