Medtronic (NYSE:MDT) touted 1 year data from the In.Pact SFA Japan trial of its drug-coated balloon compared to plain balloon angioplasty. The company also said today it won regulatory approval in Canada for its In.Pact Admiral DCB in patients with peripheral artery disease in the upper leg.
The Japan trial enrolled 100 patients, 68 of whom were treated with the DCB and 32 with plain balloon angioplasty. Primary patency, or restoration of adequate blood flow through the treated segment of diseased artery, was 89.2% for the DCB group and 48.4% for the control group at 12-months follow-up.
Clinically-driven target lesion revascularization was 2.9% for the DCB group, compared to 18.8% in the angioplasty group.
The data also showed significantly fewer major adverse events for the DCB group at 1 year compared to their counterparts, with no major target limb amputations.
“The MDT-2113 IN.PACT SFA Japan Trial represents our global commitment to deliver robust clinical evidence to aid in the choice of treatment options for patients with PAD,” VP & general manager of Medtronic’s peripheral business Mark Pacyna said in prepared remarks. “We are pleased to be the first to present data comparing a DCB to angioplasty in Japan.”
The Medtronic DCB is investigational in Japan and not available commercially.
“This study builds on the previous Medtronic DCB clinical studies, reinforcing the consistent clinical performance in terms of primary patency and re-intervention rates of this device across patient populations,” Dr. Osamu Iida, from the Kansai Rosai Hospital in Hyogo, Japan, added. “We are pleased to see such substantive DCB clinical data from a patient cohort in Japan.”
In January, the Fridley, Minn.-based company said that the FDA approved its investigational device exemption application for a study to evaluate its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease.
Medtronic said that its study will compare its DCB to plain balloon angioplasty as a treatment for failing arteriovenous fistulas. The primary efficacy endpoint for the 330-patient study is patency of dialysis fistulas through 6 months and the primary safety endpoint is major adverse events through 30 days. Additional endpoints include reducing access circuit related events.