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Boston Scientific's MAJESTIC Trial Results to Aid PAD Cure

Medical device major Boston Scientific CorporationBSX recently revealed favorable 12-month clinical results of its MAJESTIC trial, which validated the clinical efficacy of the company's Eluvia Drug-Eluting Vascular Stent System in treating patients suffering from peripheral artery disease (PAD). According to the company, an impressive patency rate of over 96% was observed at one year among the patients enrolled in this study, accompanied by low major advance events.

The study results also demonstrated a low target lesion revascularization (TLR) rate of 3.8% at 12 months, with no observed stent fractures and zero amputations. Moreover, 94% of the patients exhibited no or minimal claudication (pain caused by insufficient blood flow).

Boston Scientific had originally initiated the multicenter MAJESTIC trial in July 2013 to determine whether its Eluvia Drug-Eluting Stent (DES) System shows acceptable performance in treating Superficial Femoral (SFA) or Proximal Popliteal Artery (PPA) lesions in PAD patients.

Currently, the Eluvia System is awaiting CE Mark approval in Europe, while in the U.S., it is under investigation and is not available for sale as yet. Management believes the study data from the MAJESTIC trial, which came in favor of Eluvia, will support the system's global regulatory submissions.

Notably, PAD is a circulatory disorder resulting from a build-up of plaque in one or more arteries, most often in the legs. With the aggravation of PAD in a patient, plaque accumulation may reduce blood flow through the arteries significantly. This may result in pain and increasing disability with severe cases even leading to amputation of the affected limb.

In recent times, PAD has become a major cause of worry all over the world. As per latest data released by Centers for Disease Control and Prevention (CDC), approximately 8 million people in the U.S suffer from PAD. However, general population awareness of the same is only 25% indicating huge untapped potential.

Against such a backdrop, Boston Scientific's Eluvia Stent System is the first stent specifically designed to treat SFA lesions, utilizing an anti-restenotic drug which prevents tissue growth that might otherwise block the stented artery. Management believes the MAJESTIC trial outcome is reflective of the company's strong efforts to promote revolutionary therapy solutions that will transform the lives of PAD patients who face the risk of serious complications including infections and amputations.

We expect the aforementioned study results to expedite the approval process of the device across the global market and allow Boston Scientific to expand its foothold in the global peripheral vascular devices market, which is expected to grow at a CAGR of 7.3% during 2014-19.

Further, Boston Scientific has received an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA) to begin a global, pivotal study called IMPERIAL trial, to further evaluate the Eluvia Stent System. The study is designed to support future regulatory submissions and patient enrollment is expected to begin in the coming months.

The cited developments indicate the steady progress Boston Scientific is making in its Peripheral Intervention (PI) business. We believe once the Eluvia Stent system receives sales approval in the market, it will bring in higher profits for the company's PI business, in the near future.

Currently, Boston Scientific has a Zacks Rank #2 (Buy). Some other top-ranked medical product stocks are ICU Medical, Inc. ICUI , OraSure Technologies, Inc. OSUR and Enzymotec Ltd. ENZY . All the three stocks sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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