Boston Scientific Corporation
) recently commenced a trial for its next-generation Ingevity
pacing leads. The first patient was implanted to evaluate the
safety, effectiveness and performance of the leads.
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Pacing leads are insulated wires to treat bradycardia by
connecting the implantable pacemaker to the patient's heart.
Bradycardia is a condition, where the heart beats too slowly and
curbs oxygen supply to the body. In order to maintain the
required heart rate for a physical activity, pacemakers and leads
work together to stimulate the heart rate, thereby avoiding
oxygen deficiency in the body.
The trial will establish whether Ingevity pacing leads are
superior to standard leads currently available. The performance
will be assessed on the basis of adjustability, reliability,
fixation and electrical performance of Ingevity.
Also worth mentioning in this context is the ability of Ingevity
leads to function in a magnetic resonance imaging (MRI)
environment. This could present an advantage over standard leads
as many patients with pacemakers are barred from undergoing an
MRI scan, as powerful magnets used in MRI scans may interfere
with pacemaker functionality.
The non-randomized study will be used by Boston Scientific to
support the regulatory filing of Ingevity in the U.S. and the EU.
Boston Scientific is also looking to study Ingevity leads with
its Ingenio pacemakers. The company plans to initiate a study in
the first half of 2013 to assess the performance of the
Ingevity-Ingenio combination in MRI scans. Results from this
study will be used to seek FDA approval for using Boston
Scientific's Ingevity and Ingenio in conjunction.
Acknowledging the challenges at play in its core segments, Boston
Scientific is focusing on strategic initiatives like portfolio
expansion, restructuring initiatives, emerging markets and share
buyback programs. With the dismal performance of the company's
Cardiac Rhythm Management (CRM) line, product approvals in latent
areas should help reduce the impact of the sluggish CRM
market. A similar strategy is also being followed by its
St. Jude Medical
We currently have a long-term 'Neutral' recommendation on Boston
Scientific, which carries a short-term Zacks #3 Rank (Hold). Its
Johnson & Johnson
) carries a Zacks #2 Rank (Buy).