US hospitals this week began using the IN.PACT Admiral drug-coated balloon (Medtronic plc) to treat patients with peripheral arterial disease in the superficial femoral and popliteal arteries.
Recently approved by the US FDA, the IN.PACT Admiral drug-coated balloon offers patients a new therapy option that has demonstrated the best clinical outcomes ever reported for this disease state and has been proven to reduce the need for costly repeat procedures that are commonly associated with other available interventional therapies.
The first uses of the new medical device following US FDA approval took place at New York-Presbyterian Hospital/Columbia University Medical Center by William Gray; Detroit Medical Center’s Harper Hospital by Mahir Elder; Yuma Regional Medical Center by Joseph Cardenas of the Heart Center of Yuma; and Terrebonne General Medical Center in Houma, by Craig Walker of Cardiovascular Institute of the South.
“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,” said Gray.
“Based on the trial results, which were recently published in the journal Circulation, I see the IN.PACT Admiral drug-coated balloon fast becoming a first-line therapy option for patients with this condition.”
The US launch of the IN.PACT Admiral begins about a week after Medtronic completed its acquisition of Covidien. This acquisition significantly expands Medtronic’s peripheral vascular sales force, which will facilitate access to the new device.
The IN.PACT Admiral DCB received the CE mark in 2009 and has been widely adopted by European physicians, leading the market with nearly 100,000 patients treated.