) focus on portfolio expansion is yielding results with several
product approvals. Recently, the company received approval from the
US Food and Drug Administration (FDA) for its Epic vascular stent,
which is meant to open blocked arteries in patients with iliac
artery stenosis. This condition is associated with severe leg pain
caused by insufficient blood flow. The Epic vascular stent is CE
Mark approved and was launched in Europe and other international
markets in 2009.
Earlier this year, Boston Scientific had announced that the
Orion trial met its primary clinical endpoint. The Epic vascular
stent recorded only 3.4% of major adverse events in the nine-month
period (in the intent-to-treat population), significantly lower
than the pre-specified performance goal of 17%.
The FDA approval of the Epic stent will strengthen the company's
Peripheral Interventions portfolio and will complement its Express
LD balloon-expandable iliac stent. This segment recorded an
8% increase in sales to $190 million during the most recent
The FDA approval of Epic vascular stent comes on the heels of CE
Mark approval and subsequent launch of Innova self expanding bare
metal stent earlier this week. The Innova stent is designed to
treat peripheral vascular lesions in arteries above the knee.
Boston Scientific is continuing with 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.
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.
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.
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.