First Uses of New Medical Device Following FDA Approval Take Place at Hospitals Nationwide
DUBLIN - U.S. hospitals this week began using a new medical device from Medtronic plc (NYSE: MDT) called the IN.PACT Admiral drug-coated balloon (DCB) to treat patients with peripheral arterial disease (PAD) in the upper leg, a common cardiovascular condition that causes leg pain and increases the risk of heart attack and stroke.
Recently approved by the U.S. Food and Drug Administration, the IN.PACT Admiral DCB 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.
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The first uses of the new medical device following FDA approval took place at NewYork-Presbyterian Hospital/Columbia University Medical Center by William Gray; Detroit Medical Center's Harper Hospital in Michigan by Mahir Elder; Yuma Regional Medical Center in Arizona by Joseph Cardenas of the Heart Center of Yuma; and Terrebonne General Medical Center in Houma, Louisiana 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 Dr. Gray. "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 U.S. launch of the IN.PACT Admiral DCB 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 is designed to reopen arteries located in the upper leg, specifically the superficial femoral and popliteal arteries, when they have been narrowed or blocked by plaque. Once deployed in the artery, the balloon delivers a proven, safe and effective dose of the anti-restenotic drug paclitaxel to the artery walls. The drug aims to prevent the artery from narrowing again by minimizing scar tissue formation.
The DCB arm of the IN.PACT SFA Trial demonstrated the lowest clinically-driven target lesion revascularization (CD-TLR) rate ever reported for an interventional treatment of PAD in the superficial femoral artery (SFA), with only 2.4 percent of patients treated with the IN.PACT Admiral DCB requiring a repeat procedure at one year, compared to one in five patients (20.6%) treated with percutaneous transluminal angioplasty (PTA).
