BSX Progresses on Prevail Trial - Analyst Blog

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With its core segments of stents and defibrillators struggling, leading medical devices player Boston Scientific Corporation ( BSX ) is targeting other emerging therapies with high potential to drive its top line. The company has progressed on the development of one such product, Watchman, in the US with completion of enrollment in the Prevail confirmatory study.

Watchman was incorporated in Boston Scientific's portfolio with the acquisition of Atritech in March 2011. The device is employed to close the left atrial appendage in patients with atrial fibrillation ("AF") who are at risk of ischemic stroke and are eligible for long-term oral anticoagulation therapy such as warfarin. The Watchman device was approved for marketing in Europe and some countries in Asia in 2005.

The randomized Prevail trial, enrolling 407 patients across 42 sites, is comparing the device to warfarin in high-risk patients with AF eligible for long-term warfarin therapy.  In addition, patient follow-up of six months is required before submission to the FDA. Patients were randomly selected to receive either the Watchman device or remain on long-term warfarin therapy. Even the patients receiving the device remained on warfarin for 45 days following implant.  

Two other studies were earlier conducted for the Watchman device, namely the Protect AF trial and the ASA Plavix ("ASAP") study. In the former, conducted with 707 patients, the device was found to be non-inferior to warfarin. Additionally, Watchman demonstrated a 38% relative risk reduction for events such as stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy. 

Likewise, data from the ASAP study showed a 77% reduction of ischemic stroke risk in patients with AF who were implanted with the Watchman device and were not eligible for blood-thinning medications.

We consider the successful commercialization of the Watchman device to be beneficial to a large patient population as AF affects approximately 15 million globally. It is a disorder that disrupts the heart's ability to beat regularly and pump blood efficiently. Traditional treatment for AF patients who run a higher risk of stroke was confined to the use of anticoagulants. Watchman has been developed as an alternative to anticoagulation therapy.

We are impressed with Boston Scientific's focus on portfolio expansion that should provide some cushion to the declining sales of stents and defibrillators. One such recent attempt has been the Cameron Health acquisition that has brought in a subcutaneous implantable cardioverter defibrillator. Several other players in the medical devices space such as Medtronic ( MDT ) and St Jude Medical ( STJ ) are also resorting to various alternatives to revive their flagging top line.

We have a Neutral recommendation on Boston Scientific. The stock retains a Zacks #3 Rank (Hold) in the short term.


 
BOSTON SCIENTIF (BSX): Free Stock Analysis Report
 
MEDTRONIC (MDT): Free Stock Analysis Report
 
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: BSX , MDT , STJ

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