Medical device major, Medtronic, Inc. (MDT), can now sell its IN.PACT Admiral drug-coated balloon (DCB) in the U.S. market, following the receipt of the U.S. Food and Drug Administration's (FDA) approval for the same.
This IN.PACT Admiral DCB can be used for the interventional treatment of those who suffer from peripheral artery disease (PAD) in the upper leg. PAD refers to a serious yet common cardiovascular state in which narrowed arteries reduce blood flow to the limbs, thereby increasing the chance of a heart attack and a stroke.
Medtronic's IN.PACT Admiral DCB helps in reopening narrowed or blocked arteries located in the upper leg of a PAD patient by delivering an effective dose of anti-restenotic drug – paclitaxel. The drug prevents the arteries from re-narrowing by minimizing scar tissue formation.
We note that the IN.PACT Admiral DCB is already sold in Europe after it received CE mark approval in 2009. So far, 100,000 PAD patients in Europe have been treated with the device, making it the market leader in the region.
Approval of this device in the U.S. was based on positive results from the IN.PACT SFA trial. Data from the trial were published in the scientific journal, Circulation, in Dec 2014. This landmark study showed a significant reduction in the target lesion revascularization, from 20.6% in the patients who received traditional percutaneous transluminal angioplasty (PTA) treatment, to 2.4% in those who were given DCB treatment.
The trial not only demonstrated the clinical efficacy of Medtronic's DCB device in treating PAD patients, but also disclosed its economic value. Evidently, in Sep 2014, an interim economic analysis of the IN.PACT SFA Trial had revealed the cost effectiveness of IN.PACT Admiral DCB compared to standard balloon angioplasty, when a 1-year follow up was conducted on the trial patients.
We believe this FDA approval opens roads for a revolutionary therapy choice for PAD patients in the U.S. Moreover, it also ensures support in reducing the overall healthcare cost of the nation in the long run, on account of the device being a cost-efficient one.
Notably, in Oct 2014, medical equipment manufacturer CR Bard Inc.'s (BCR) Lutonix 035 DCB Catheterfor PTA won FDA approval, marking it the first ever DCB device to have been approved by FDA in the U.S. We believe this will give Medtronic a competitive leverage in the U.S. market, given that 750,000 to 800,000 people in the U.S. and Western Europe require PAD treatment each year.
During its last reported second quarter fiscal 2015 results, Medtronic's peripheral business expanded by 4% on a year-over-year basis. Management expects this FDA approval to further growth in this business in the coming quarters.
Zacks Rank
Currently, Medtronic carries a Zacks Rank #3 (Hold), while CR Bard holds a Zacks Rank #2 (Buy). Other well-ranked medical products stocks include ICU Medical, Inc. (ICUI) and Conatus Pharmaceuticals Inc. (CNAT). While ICU Medical sports a Zacks Rank #1 (Strong Buy), Conatus bears a Zacks Rank #2.
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