Boston Scientific Corporation
) has strengthened its stent portfolio in Europe with the CE Mark
approval and subsequent launch of Innova self expanding bare metal
stent. The stent is designed to treat peripheral vascular lesions
in arteries above the knee. Mauro Gargiulo, physician at
Sant'Orsola-Malpighi in Bologna, Italy considers treatment of
arteries above the knee to be difficult. This is because the
anatomy of this region can lead to stent fractures and higher
The launch of the Innova stent will be of immense benefit to
several patients as, according to estimates in Europe, Peripheral
vascular disease ("PVD") affects 13 million people or one in 20
people over 40 years old. PVD results from a build-up of plaque in
one or more of the arteries of the legs. As the disease progresses,
plaque accumulation may significantly reduce blood flow through the
arteries, resulting in pain and increasing disability.
Boston Scientific is continuing patient enrollment in the
SuperNOVA clinical trial to support its application for US approval
of the Innova stent. The trial expects to enroll up to 300
patients at 50 sites in the US, Canada and Europe, and is expected
to be completed in the first half of 2013.
Although Boston Scientific continues to witness various
headwinds in its core segments of stents and defibrillators, the
company is working on portfolio expansion. The launch of Innova in
Europe is one such step of the company. Other players in the
medical devices space such as
St Jude Medical
) are also resorting to various alternatives to revive their top
The earlier-than-expected approval of Promus Element in the US
(in November 2011) followed by its approval in Japan and Canada,
both in March 2012, should boost drug eluting stent ("DES") sales.
We are also encouraged by the launch of Ingenio and Advantio
pacemakers and Invive cardiac resynchronization therapy pacemakers
in Europe in April 2012, followed by FDA approval in May 2012.
Some of the other significant products in the pipeline include
the fourth generation Synergy DES (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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