With the CE Mark approval based on the results from the ASAP
(ASA Plavix) study, Boston Scientific 's (
Watchman Left Atrial Appendage ("LAA") Closure Device can now be
used to treat an expanded patient population. Subsequently,
patients with atrial fibrillation ("AF") who are at high risk of
stroke and cannot take anticoagulant therapy would benefit from
this recent approval.
AF, affecting approximately 15 million people globally, disrupts
the ability of the heart to beat regularly and pump blood
efficiently. Watchman is introduced into the heart via a flexible
catheter to close off the LAA and capture any clots formed in the
appendage. This reduces the risk of stroke and thereby eliminates
the need for long-term use of blood thinning medications.
In another development, the European Society of Cardiology
included LAA closure devices in the revised Guidelines for
Management of Patients with Atrial Fibrillation . This
was based on favorable data from the PROTECT AF trial, which
demonstrated that the Watchman device was non-inferior to warfarin
and resulted in a 38% relative risk reduction for stroke,
cardiovascular death and systemic embolism compared to long-term
warfarin therapy. Besides, the ASAP Registry demonstrated a 77%
reduction for ischemic stroke in patients contraindicated to
The Watchman device was inducted in Boston Scientific's
portfolio following the acquisition of Atritech in March 2011.
While the device is approved in Europe since 2005 and in some Asian
countries since 2009, the company is yet to receive approval in the
US. Boston Scientific has completed enrollment in the PREVAIL
study, a confirmatory study to gain approval from the US Food and
Drug Administration. The company is looking at receiving approval
in fiscal 2013.
The challenges rife in the core segment of stents and
defibrillators do not show any sign of abatement . This is
also reflected in the lowering of the outlook for 2012 .
As a result , Boston Scientific is looking at other new
therapies to drive its top line. To achieve this objective, the
company has been active on the acquisition front. The latest is the
acquisition of Cameron Health, with which Boston Scientific will
have access to the S-ICD system, a subcutaneous implantable
cardioverter defibrillator ("ICD"). However, the competitive
landscape remains tough with the presence of
Medtronic ( MDT )
and St Jude Medical ( STJ
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
MEDTRONIC (MDT): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis
To read this article on Zacks.com click here.