Boston Scientific Corporation
) has received revised labeling from the US Food and Drug
Administration ("FDA") for its Incepta, Energen, Punctua, Cognis
and Teligen implantable cardioverter defibrillators (ICDs) and
cardiac resynchronization therapy defibrillators (CRT-Ds). The
revised labeling increases the longevity projection for these
devices indicating that some ICDs may last for more than ten years
and almost eight years for some CRT-Ds.
Recently, data presented at a meeting in Boston demonstrated
that treatment with defibrillator benefits patients for a median
follow-up of 11 years. Besides, it has been observed that a
defibrillator may extend a patient's life (New York Heart
Association Class II patients) for at least a decade by saving him
from sudden cardiac death. Reduced frequency to replace these
devices will help patients by reducing complications associated
with the procedures as well as involve financial benefit.
Boston Scientific had received FDA approval for Incepta, Energen
and Punctua CRT-Ds and ICDs in November 2011. CE Mark approval for
these defibrillators was received in the second quarter of 2011.
The rollout of these products is currently underway in the US
market and feedback from customers has been positive so
Boston Scientific's focus on portfolio expansion is inevitable
in the face of severe headwinds in its core segments of stents and
defibrillators. Other players in the medical devices space such as
St Jude Medical
) are also resorting to various alternatives to revive their
flagging top line.
The company's focus on portfolio expansion is yielding results
with several product approvals. Last month, the company received
FDA approval for the Epic vascular stent, which is meant to open
blocked arteries in patients with iliac artery stenosis. The FDA
approval of the Epic vascular stent comes on the heels of CE Mark
approval and subsequent launch of Innova self expanding bare metal
stent. The Innova stent is designed to treat peripheral vascular
lesions in arteries above the knee.
Some of the other significant products in the company's pipeline
include the fourth generation Synergy drug eluting stent (CE Mark
expected in late 2012 with full launch in 2013) and Vercise deep
brain stimulation program for the treatment of Parkinson's disease.
Both these technologies are expected to contribute to revenues from
2013 and incrementally in 2014.
We have a Neutral recommendation on Boston Scientific. The stock
retains a Zacks #3 Rank (hold) in the short term.
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