With its core segments of stents and defibrillators struggling,
leading medical devices player
Boston Scientific Corporation
) 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
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
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
St Jude Medical
) 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.
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