Medtronic Submits Final PMA Module to FDA for In.Pact Admiral DCB to Treat Femoropopliteal Disease

June 11, 2014—Medtronic, Inc. announced that it has submitted the final module of its premarket approval (PMA) application for the In.Pact Admiral drug-coated balloon to the US Food and Drug Administration (FDA). The company projects that it will receive FDA approval of the In.Pact Admiral in early fiscal year 2016. The In.Pact Admiral drug-coated balloon received European CE Mark approval in 2009. In the United States, it remains an investigational medical device under review by the FDA.

The company advised that the application includes data demonstrating superior clinical outcomes compared with conventional angioplasty, with the lowest rates of target lesion revascularization and the highest rate of primary patency at 12 months ever reported for the interventional treatment of peripheral artery disease.

Medtronic describes the In.Pact Admiral drug-coated balloon as being designed for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA) or proximal popliteal artery. The device leaves no scaffolding behind in the SFA. The company’s FreePac coating, a formulation of paclitaxel and the natural excipient urea, facilitates rapid absorption of the drug into the vessel wall and prevents excess scar tissue from forming along the wall of the treated arterial segment.

The final PMA module includes landmark pivotal data from the IN.PACT SFA trial that were presented at the 2014 Charing Cross International Symposium in April in London, United Kingdom and the EuroPCR conference in May in Paris, France.

The IN.PACT SFA trial is investigating In.Pact Admiral for the treatment of PAD in the SFA or proximal popliteal artery compared to standard balloon angioplasty. At 12-month follow-up, both primary endpoints showed a highly statistically significant difference between treatment groups.

As detailed by Medtronic, clinically driven target lesion revascularization rates were 2.4% in the drug-coated balloon (DCB) patients and 20.6% for the percutaneous transluminal angioplasty (PTA) patients (P < .001). Primary patency rates were 82.2% for the DCB patients and 52.4% for the PTA patients (P < .001). Primary patency calculated by Kaplan-Meier survival estimates at 360 days was 89.8% for the DCB patients and 66.8% for the PTA patients.

Also included in the application are new data from the first 650 patients in the IN.PACT Global study, a real-world, 1,500-patient evaluation of the In.Pact Admiral drug-coated balloons for the treatment of femoropopliteal lesions. The IN.PACT Global study is providing important data about more complex anatomical and clinical patient characteristics.

John Laird, MD, interventional cardiologist at UC Davis Medical Center in Sacramento, California, is coprincipal investigator of the IN.PACT SFA trial. In Medtronic’s press release, Dr. Laird commented, “The introduction of drug-coated balloons in the United States for the treatment of peripheral artery disease in the SFA is highly anticipated as a new standard of care for this difficult-to-treat condition, especially due to the consistently strong clinical data we’ve witnessed with In.Pact Admiral. The In.Pact Admiral clinical program has raised the bar for the industry and may reduce the need for traditional interventions as first-line treatment, such as metal stents, which are not ideally suited for this dynamic artery.”

With a combination of physician-initiated and company-sponsored studies, the ongoing global clinical program of In.Pact drug-coated balloons for the treatment of PAD in the lower extremities involves more than 4,200 patients across 24 studies worldwide, noted Medtronic.