FDA Approval for BSX Epic Stent - Analyst Blog


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Boston Scientific 's ( BSX ) 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 quarter.

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 Medtronic ( MDT ) and St Jude Medical ( STJ ) 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 Report
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