Medtronic, Inc.: Medtronic Drug-Coated Balloon for Peripheral Artery Disease Tops Standard Balloon Angioplasty in Landmark

The results of a landmark study published thismonth in Circulation, the world's leading cardiovascular journal, indicatethat a novel medical device from Medtronic, Inc. (NYSE: MDT) called theIN.PACT Admiral drug-coated balloon (DCB) significantly outperformed standardballoon angioplasty in the treatment of symptomatic peripheral artery diseasein the upper leg -- specifically, the superficial femoral and proximalpopliteal arteries.To put the results in context, patients in the study's DCB group experiencedthe highest rate of primary patency and the lowest rate of clinically-driventarget lesion revascularization at 12 months ever reported from a study ofinterventional treatments for this common form of peripheral artery disease. In their conclusion, the authors of the article state that the IN.PACT AdmiralDCB "stands to become an important treatment option for patients withsuperficial femoral and popliteal artery disease," which affects millions ofpeople worldwide.The IN.PACT Admiral DCB received the CE (Conformité Européene) mark in 2009but remains an investigational medical device in the United States, where itis under review by the U.S. Food and Drug Administration (FDA). Outside theUnited States, the device has been used to treat peripheral artery disease innearly 100,000 patients -- more than any other DCB.The IN.PACT SFA Trial enrolled 331 subjects at 57 sites across Europe and theUnited States. All study subjects were randomized to treatment with the DCB orstandard balloon angioplasty. On the key endpoints: o The clinically driven target lesion revascularization (CD-TLR) rates at 12 months were 2.4 percent for the DCB group and 20.6 percent for the PTA group (p