FDA Approves Medtronic’s In.Pact Admiral DCB to Treat SFA and Popliteal Artery Disease
January 5, 2015—Medtronic, Inc. announced that the US Food and Drug Administration (FDA) has approved the company’s In.Pact Admiral drug-coated balloon (DCB) for the interventional treatment of peripheral artery disease (PAD) in the superficial femoral and popliteal arteries. The In.Pact Admiral DCB received European CE Mark approval in 2009.
The In.Pact Admiral DCB features the company’s coating of the drug paclitaxel and the excipient urea, which facilitates transfer of the drug from the balloon into the artery wall. Paclitaxel is delivered in a 3.5-µg/mm2 dose to maximize therapeutic benefit and remains at therapeutic levels for up to 180 days. The device is available in lengths of 40, 60, 80, and 120 mm and can accommodate vessels ranging from 4 to 7 mm in diameter.
In Medtronic’s announcement, Michael R. Jaff, DO, commented, “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. Data from clinical trials evaluating this new drug-coated balloon have consistently demonstrated improved patient outcomes.” As the Medical Director of VasCore, the Vascular Ultrasound Core Laboratory, Dr. Jaff participated in the studies that led to the device’s FDA approval. Dr. Jaff is the Paul and Phyllis Fireman Chair in Vascular Medicine at the Massachusetts General Hospital and Professor of Medicine at Harvard Medical School in Boston, Massachusetts.
According to the company, the DCB arm of the IN.PACT SFA trial demonstrated the lowest clinically driven target lesion revascularization rate ever reported for an interventional treatment of PAD in the superficial femoral artery. Only 2.4% of patients treated with the In.Pact Admiral DCB required a repeat procedure at 1 year compared to 20.6% of patients treated with percutaneous transluminal angioplasty (PTA).
Medtronic stated that 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 DCB group compared to 66.8% in the PTA group. Using the trial’s protocol definition, primary patency assessed at 12 months of follow-up was 82.2% for the DCB group and 52.4% for the PTA group.
Results from an interim economic analysis of the IN.PACT SFA trial revealed that by reducing the need for repeat procedures, treatment with the In.Pact Admiral DCB is cost effective compared to balloon angioplasty from discharge through 1 year of follow-up, indicating the potential to lower overall health care costs over the longer term, noted Medtronic.
On December 22, 2014, Medtronic announced that the results of IN.PACT SFA I and IN.PACT SFA II, the landmark studies of the In.Pact Admiral DCB, were published online ahead of print by Principal Investigator Gunnar Tepe, MD, et al in Circulation.