Medtronic Launches In.Pact Admiral DCB in United States

February 4, 2015—Medtronic plc announced the United States launch of the In.Pact Admiral drug-coated balloon (DCB). On January 5, the company announced US Food and Drug Administration (FDA) approval of the device 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.

Medtronic advised on January 26 that the company completed its acquisition of Covidien, which expands Medtronic’s peripheral vascular sales force and will facilitate access to the new device.

In December 2014, Medtronic announced that Principal Investigator Gunnar Tepe, MD, et al, published the results of the IN.PACT SFA I and IN.PACT SFA II studies online ahead of print in Circulation.

The first procedures with the In.Pact Admiral DCB after FDA approval were conducted by William A. Gray, MD, at NewYork-PresbyterianHospital/Columbia University Medical Center in New York, New York; Mahir Elder, MD, at Detroit Medical Center’s Harper Hospital in Detroit, Michigan; Joseph Cardenas, MD, of the Heart Center of Yuma at Yuma Regional Medical Center in Yuma, Arizona; and Craig M. Walker, MD, of Cardiovascular Institute of the South at Terrebonne General Medical Center in Houma, Louisiana.

In the company press release, Dr. Gray commented, “As an investigator in the clinical trial that contributed to this device’s FDA approval, I have seen firsthand how well the In.Pact Admiral drug-coated balloon works as a treatment for peripheral arterial disease in the upper leg. Based on the trial results, which were recently published in the journal Circulation, I see the In.Pact Admiral DCB fast becoming a first-line therapy option for patients with this condition.”

The company noted that at 1 year, the IN.PACT SFA Trial demonstrated a low clinically driven target lesion revascularization rate of 2.4% in patients treated with the DCB compared to 20.6% in patients treated with percutaneous transluminal angioplasty (PTA). The data also showed Kaplan-Meier survival estimates for primary patency at 360 days of 89.8% 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.