MDT Cease IN.PACT Admiral Enrollment

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Medical devices major Medtronic (MDT) recently stated that it has enrolled a significant number of patients for the IN.PACT Admiral drug-eluting balloon studies. As a part of the company’s strategy to advance interventional treatments of peripheral artery disease, this enrollment is to support the company`s US regulatory approval submission for IN.PACT Admiral drug-eluting balloon. This angioplasty device is designed to treat atherosclerotic lesions in the superficial femoral artery.

Simultaneously, Medtronic is also planning to submit the first module of the pre-market approval (PMA) application for the above-mentioned device to the US Food and Drug Administration (:FDA). Currently, the IN.PACT Admiral drug-eluting balloon is limited to investigational use under an FDA approved investigational device exemption (IDE). However, the company expects the U.S. commercial launch of this angioplasty device in late 2015.

Medtronic’s Peripheral Vascular Intervention (PVI) business remains under the broader range of CardioVascular  division. This comprises procedures to treat patients with peripheral vascular disease, a narrowing or blockage of vessels outside the heart, legs and other vital organs. Similar to coronary artery disease, this peripheral vascular disease is generally treated with balloon angioplasty followed by a peripheral stent.

Apart from the percutaneous angioplasty balloons and drug-eluting balloons, the PVI products include the Complete SE stent, Assurant Cobalt Iliac Stent, Pioneer Plus lumen re-entry device as well as embolic protection devices and stents for the treatment of carotid artery disease.

We are impressed with Medtronic’s efforts to diversify its product range. We are optimistic that over the long term, stability in the U.S. core market along with a deep pipeline/portfolio that includes – CoreValve, Resolute Integrity, Atrial Fibrillation (AF), renal denervation and peripheral businesses – will be the driving factors for the company going ahead.

However, looming headwinds such as a soft economic condition, tough competition, segment pressure and currency headwinds keep us on the sidelines. Medtronic currently carries a Zacks Rank #3 (Hold). Other medical sector stocks that warrant a look are Conceptus Inc. (:CPTS), Haemonetics Inc. (HAE) and Cyberonics Inc. (CYBX). All these stocks carry a Zacks Rank #1 (Strong Buy).

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