Medtronic has announced that it recently submitted the final module of its pre-market approval application for the In.pact Admiral drug-coated balloon to the US Food and Drug Administration (FDA). The application includes data that demonstrates superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularisation) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease.
“This exciting milestone keeps us on track for FDA approval of the In.Pact Admiral drug-coated balloon in the US in early FY16,” reaffirms Tony Semedo, president of Medtronic’s endovascular therapies business. “More than 1,000 patients have been enrolled in the studies submitted to the FDA. The breadth and depth of our clinical programme is unparalleled in the treatment of femoropopliteal disease across both randomised, controlled trials and real-world studies.”
The final pre-market approval module includes landmark pivotal data recently presented at the Charing Cross Symposium and EuroPCR annual meetings from the IN.PACT SFA trial, investigating In.Pact Admiral for the treatment of peripheral artery disease in the superficial femoral artery or proximal popliteal artery (both located in the leg above the knee), compared to standard balloon angioplasty. At 12 months follow-up, both primary endpoints showed a highly statistically significant difference between treatment groups:
- Clinically driven target lesion revascularisation (CD-TLR) rates were 2.4% in the drug-coated balloon patients and 20.6% for the percutaneous transluminal angioplasty patients (p<0.001).
- Primary patency rates were 82.2% for the drug-coated balloon patients and 52.4% for the percutaneous transluminal angioplasty patients (p<0.001). Primary patency calculated by Kaplan-Meier survival estimates at 360 days was 89.8% for the drug-coated balloon patients and 66.8% for the percutaneous transluminal angioplasty patients.
Also included in the application is new data from the first 650 patients in the IN.PACT Global study, a first-of-its-kind, “real-world” 1,500-patient evaluation of the In.Pact Admiral drug-coated balloons for the treatment of femoropopliteal lesions providing important data about more complex anatomical and clinical patient characteristics.
“The introduction of drug-coated balloons in the USA for the treatment of peripheral artery disease in the superficial femoral artery 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,” says John Laird, co-principal investigator of IN.PACT SFA, and interventional cardiologist, UC Davis Medical Center, California, USA. “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.”
The In.Pact Admiral drug-coated balloon received the CE mark in 2009 but remains an investigational medical device in the USA, where it is under review by the US Food and Drug Administration. No drug-coated balloon has yet received FDA approval.