Medtronic touts low CD-TLR rates, strong durability in 3-year In.Pact Admiral DCB study | VIVA 2016 Roundup

Medtronic (NYSE:MDT) this week released data from 2 clinical studies evaluating its In.Pact Admiral drug-coated balloon for treating claudication and restenosis, touting sustained durability at 3-years.

Results were presented at the Vascular Interventional Advances 2016 conference in Las Vegas this week.

3-year outcomes from the In.Pact SFA trial showed Medtronic’s balloon had long-term clinical benefit superior to plain balloon angioplasty, reported Dr. Prakash Krishnan of New York’s Mt. Sinai Heart.

“The In.Pact Admiral is the only DCB to-date with superior performance supported by three-year data,” Dr. Krishnan said. “In line with the 1- and 2-year data, we saw a consistently low clinically-driven target lesion revascularization rate and high patency rate. These durable, long-term outcomes reinforce the shift we are seeing in adoption of In.Pact Admiral DCB as the primary treatment option for SFA treatment.”

The device giant enrolled 331 patients at 57 sites across Europe and the U.S. to evaluate the company’s DCB as treatment for claudication and restenosis for patients with superficial femoral artery (SFA) disease.

Results from the study indicated a 69.5% rate of primary patency, significantly higher than the 45.1% rate reported for patients in the plain balloon angioplasty arm.  Rates of clinically-driven target lesion revascularization were 15.2% for the In.Pact group, and higher at 31.1% for patients in the PTA arm.

Time before requiring follow-up procedures was over 200 days longer for patients treated with the In.Pact at 542.9 days compared to 302.9 for PTA.

“When evaluating quality of data, it’s important to consider the clinical rigor built into the study design,” Medtronic aortic & peripheral vascular biz medical director Dr. Mark Turco said. “This is why Medtronic has made significant investments in independent adjudication for the In.Pact clinical program to deliver unquestionable results that clinicians have come to expect in our DCB. The 3-year In.Pact SFA data and the 1-year In.Pact Global data continue to demonstrate consistency, durability, and safety of the In.Pact Admiral DCB. We look forward to sharing additional outcomes when other data sets mature.”

Dr. Michael Jaff of the Massachusetts General Hospital added that new 1-year results from the In.Pact Global study confirmed previous findings in both safety and efficacy of Medtronic’s device. The global study includes 1,500 patients across 27 countries.

Medtronic’s In.Pact Admiral is the only DCB that the FDA has approved to treat in-stent restenosis, according to Medtronic.

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