Successful trial for IN.PACT Admiral drug-coated balloon in PAD published in Circulation- Medtronic

The results of a landmark study ( IN.PACT SFA Trial ) were published this month in Circulation, indicate that a novel medical device from Medtronic, Inc. called the IN.PACT Admiral drug-coated balloon (DCB) significantly outperformed standard balloon angioplasty in the treatment of symptomatic Peripheral Artery Disease in the upper leg -- specifically, the superficial femoral and proximal popliteal arteries. To put the results in context, patients in the study's DCB group experienced the highest rate of primary patency and the lowest rate of clinically-driven target lesion revascularization at 12 months ever reported from a study of interventional treatments for this common form of Peripheral Artery Disease.

1.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<0.001), a highly statistically significant difference. cd-tlr accounts for repeat procedures, or reinterventions, due to recurrent symptoms related to the treated lesion. 2.primary patency rates were assessed at 12 months of follow-up and showed a highly statistically significant difference: 82.2 percent for the dcb group and 52.4 percent for the pta group (p><0.001).>

The IN.PACT Admiral DCB received the CE (Conformit� Europ�ene) mark in 2009 but remains an investigational medical device in the United States, where it is under review by the FDA.

See- "Drug-Coated Balloon versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and/or Popliteal Peripheral Artery Disease: 12-Month Results from the IN.PACT SFA Randomized Trial Gunnar Tepe, et.al., published online before print December 3 2014, doi:10.1161/CIRCULATIONAHA.114.011004