|The IN.PACT Admiral drug-coated balloon in an artery--Courtesy of Medtronic|
Medtronic ($MDT) has unveiled two-year data for a drug-coated balloon to treat peripheral artery disease (PAD) that shows it can be effective in patient populations that are typically not good responders to balloon angioplasty: women and diabetics.
The trial for the IN.PACT Admiral, which has a paclitaxel coating for a sustained anti-restenotic effect, found that women and diabetics had a higher primary patency rate and a lower rate of lesion revascularization than with traditional balloon angioplasty.
"The IN.PACT Admiral drug-coated balloon's unique coating delivers paclitaxel in a solid state which results in durable tissue levels of drug leading to prolonged anti-restenotic effect. We have first-of-its-kind data that shows it continues to do so even in the more challenging cases and patient populations," said principal investigator Dr. Peter Schneider of Kaiser Medical Center in Honolulu, HI, in a statement. "These data continue to position the IN.PACT Admiral drug-coated balloon as a durable treatment option for femoropopliteal interventions."
The IN.PACT Admiral DCB got a CE mark in 2009 to treat PAD and was approved by the FDA in December 2014 to treat superficial femoral and popliteal arteries. Earlier this year, the CE mark indication was expanded to add the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease undergoing dialysis. It's been used in more than 100,000 patients.
The 1,535-patient study found that women treated with the IN.PACT Admiral DCB had a higher primary patency rate of 76.7% as compared to 42.3% for balloon angioplasty. They also had a lower clinically driven target lesion revascularization (CD-TLR) rate of 13.2% as compared to 38.2%. Diabetics has similar results with a primary patency rate of 73.3% versus 45.8% for balloon angioplasty, and a CD-TLR rate of 10.7% as compared to 29.4% for balloon angioplasty.
"The rigor, volume and cadence of strong clinical data along with the consistency of data for the IN.PACT Admiral drug-coated balloon are among the best for any anti-restenotic therapy available for the treatment of symptomatic superficial femoral artery disease," said Dr. Mark Turco, medical director of the Aortic & Peripheral Vascular Business within Medtronic's Cardiac and Vascular Group.
In its most recent earnings, Medtronic attributed the clinical differentiation of its IN.PACT Admiral balloon as enabling it to maintain its U.S. market leadership pin the drug-coated balloon segment.
Medtronic chairman and CEO Omar Ishrak said that drug-coated balloons, as well as other new products including transcatheter aortic valve replacements, MRI-safe implantable technology, atrial fibrillation ablation and predictive diagnostics, are "helping to create important rapidly growing med tech markets."
- here is the release