Recently, medical device major – Boston Scientific (BSX - Free Report) released the preliminary study result of the PREVAIL clinical trial, which successfully met 2 out of 3 co-primary endpoints. The analysis is currently available on TCTMD (For more visit- www.tctmd.com/show.aspx?id=118115).
Notably, the preliminary results of the PREVAIL Trial was supposed to be disclosed on Mar 9 at the American College of Cardiology (ACC) in California. However, the company inadvertently broke the ACC policy regarding the PREVAIL clinical trial data.
Earlier, Boston Scientific decided for a partial release of the results of PREVAIL clinical trial. However, this news of limited release acted unfavorably for the company indicating the probability of failure of some of the results to meet the suitable outcome. Consequently, BSX made another announcement stating that the PREVAIL clinical trial results presentation will include all three co-primary endpoints, showing safety and efficacy of Watchman.
The PREVAIL trial is a study on the Watchman Left Atrial Appendage Closure device, which is used to reduce chances of stroke. Apart from the earlier stated endpoint of acute occurrence of death, ischemic stroke, systemic embolism and procedure or device related complications requiring major cardiovascular or endovascular intervention, the other two endpoints are comparison of composite of stroke, systemic embolism, cardiovascular or unexplained death (at 18 months follow-up) and comparison of ischemic stroke or systemic embolism (occurring from greater than 7 days post randomization to 18 months follow-up).
The company plans to submit the results from the PREVAIL confirmatory study to the U.S. Food and Drug Administration (FDA) for approval.
However, we are concerned about several headwinds troubling Boston Scientific’s core segments. The US defibrillator market remains an overhang for the company and its peers, St Jude Medical (STJ - Free Report) and Medtronic (MDT - Free Report) . The DES business in the U.S. has been witnessing challenges due to pricing pressure, lower procedural volume, lower penetration rates and share losses from the launch of Medtronic's Resolute Integrity stent.
Nonetheless, to revive its top line, Boston Scientific is focusing on strategic initiatives to drive growth and profitability. These include restructuring initiatives, strengthening its portfolio, targeting suitable acquisitions in areas of unmet medical needs and focusing on emerging markets.
The stock currently carries a Zacks Rank #3 (Hold). Its peer Edwards (EW - Free Report) carries a Zacks Rank #2 (Buy).