The submission includes data demonstrating "superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularization) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease," according to a press release.
Medtronic is on track to win FDA approval in early fiscal 2016, according to endovascular therapies president Tony Semedo.
"More than 1,000 patients have been enrolled in the studies submitted to the FDA. The breadth and depth of our clinical program is unparalleled in the treatment of femoropopliteal disease across both randomized, controlled trials and real-world studies," Semedo said in prepared remarks.
The PMA submission also encompassed data revealed in April, Medtronic said, showing TLR rates of 2.4% after 12 months, compared with 20.6% for the control arm, and primary patency rates of 82.2% for the DEB cohort and 52.4% for the control group. It also included new data from the first 650 patients in Medtronic’s global In.Pact trial, which the company claimed is a first-of-its-kind, real-world study that’s slated to enroll 1,500 patients.
Medtronic is chasing C.R. Bard (NYSE:BCR) for the DEB market; Bard filed the last module in its PMA application in November 2013 for its Lutonix DEB, and an FDA advisory panel is slated to meet tomorrow to review the device.