Boston Scientific Corporation (BSX) presented results from its Orion trial at a conference in Miami. The study, which enrolled 125 patients, demonstrated positive outcome for its Epic self-expanding nitinol stent system in patients with iliac artery disease. This is a form of peripheral artery disease associated with severe leg pain caused by insufficient blood flow.
The company announced that the trial met its primary endpoint. Besides, patients experienced significant clinical improvement over the nine month period with respect to walking distance, speed and stair climbing.
The Epic stent was launched in Europe and other international markets in 2009. However, the device has yet to receive approval in the US. Boston Scientific expects to use the clinical data from the Orion trial to support the US approval, application of which was submitted to the Food and Drug Administration in September 2011.
Growth in the Peripheral Interventions (“PI”) stent systems during the most recent quarter was driven by the Epic self-expanding nitinol stent system in certain international markets and the Carotid Wallstent stent system in Japan. Products slated to be launched in 2012 would drive the top line further. The company expects to launch the Epic stent system in the US in late 2012 or early 2013.
Last month, Boston Scientific strengthened its PI business with the launch of Charger percutaneous transluminal angioplasty balloon catheter, which is indicated for a wide range of peripheral angioplasty procedures including post-stent dilatation. This was the third new peripheral balloon catheter launched in 2011, which was preceded by Mustang percutaneous transluminal angioplasty balloon (June 2011) and the Coyote balloon catheter (September 2011). Both Mustang and Coyote resulted in increased market share for the company.
Boston Scientific’s acquisition of S.I. Therapies and ReVascular Therapeutics in February 2011 further expanded the PI portfolio with a re-entry catheter and intraluminal chronic total occlusion (“CTO”) crossing device, enabling endovascular treatment in cases that typically cannot be treated with standard endovascular devices.
Despite a steady stream of product launches, times are trying for MedTech companies. The core segments of stents and defibrillators are struggling for growth due to pricing pressure and a loss of market share. Boston Scientific is not alone in this struggle and its peers Medtronic (MDT) and St Jude Medical (STJ) are also witnessing similar challenges. In this scenario, the company is working on reviving its top line by expanding its product portfolio, either through pipeline development or strategic acquisitions.
Boston Scientific currently retains a Zacks #3 Rank (short-term Hold rating). We also maintain our long-term Neutral recommendation on the stock.
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