Medtronic announced today (5 January 2015) that the FDA has approved the company’s IN.PACT Admiral drug-eluting balloon for the treatment of superficial femoral artery and popliteal artery lesions.
The drug-eluting balloon arm of the IN.PACT SFA trial demonstrated the lowest clinically-driven target lesion revascularisation rate ever reported for an interventional treatment of peripheral arterial disease in the superficial femoral artery, with 2.4% of patients treated with the IN.PACT Admiral device requiring a repeat procedure at one year, compared to one in five patients (20.6%) treated with percutaneous transluminal angioplasty.
The data also revealed the highest reported rates of primary patency. Based on Kaplan-Meier survival estimates for primary patency at 360 days, the data showed an 89.8% sustained restoration of blood flow in the drug-eluting balloon group compared to 66.8% for the angioplasty group. Using the trial’s protocol definition, primary patency assessed at 12 months of follow up was 82.2% for the drug-eluting balloon group and 52.4% for the angioplasty group.
According to Medtronic, the exceptionally positive clinical data from the pivotal IN.PACT SFA trial have been approved by the FDA without the use of an independent advisory panel.
The company also states that by reducing the need for repeat procedures, the new device is also proving to be economically attractive. Results from an interim economic analysis of the IN.PACT SFA trial revealed that treatment with the IN.PACT Admiral drug-eluting balloon is cost-effective compared to balloon angioplasty from discharge through one-year of follow-up, indicating the potential to lower overall healthcare costs over the longer term.
“The introduction of drug-coated balloons represents a significant breakthrough that might establish a new standard of care with its potential to change the way we treat peripheral artery disease in the leg,” says Michael R Jaff, Massachusetts General Hospital and Harvard Medical School in Boston, USA, who participated in the studies that led to the new device’s FDA approval as the medical director of VasCore, the Vascular Ultrasound Core Laboratory. “Data from clinical trials evaluating this new drug-coated balloon have consistently demonstrated improved patient outcomes.”
“Having shown success in Europe for several years, we are excited to bring the IN.PACT Admiral drug-eluting balloon to patients and physicians in the USA,” says Tony Semedo, senior vice president and president of Medtronic’s Aortic and Peripheral Vascular business. “In addition to being a key growth driver, the IN.PACT Admiral drug-eluting balloon delivers on our commitment to providing innovative technologies that not only provide clinical benefit, but also economic value.”
The IN.PACT Admiral device received the CE mark in 2009. The device features a proprietary coating of the drug paclitaxel and a naturally occurring excipient called urea, which facilitates transfer of the drug from the balloon into the artery wall. Paclitaxel is delivered in a 3.5µg/mm2 dose to maximise therapeutic benefit and remains at therapeutic levels for up to 180 days. The device is available in 40, 60, 80, and 120mm lengths and can accommodate vessels ranging from 4–7mm in diameter.
The IN.PACT Admiral device is the second drug-eluting balloon approved in the USA. In October, the FDA approved the Lutonix device from Bard.