Medtronic, Inc. has submitted the final module of its pre-market approval (PMA) application for the IN.PACT Admiral drug-coated balloon to the U.S. FDA.
The Superficial Femoral Artery (SFA) runs close to the surface of the upper leg, from the groin to the knee and is subject to the most intense dynamic forces such as torsion and compression, which pose inherent challenges for permanent metallic stents. For this reason, among others, balloon dilatation is considered a viable alternative treatment for vascular lesions in this area. Aiming to be the first drug-coated balloon to gain FDA’s nod, Medtronic’s IN.PACT Admiral drug-coated balloon leaves no scaffold behind in the SFA. Its proprietary coating called FreePac, a formulation of the antiproliferative drug paclitaxel and the natural excipient urea, facilitates rapid absorption of the drug into the vessel wall and prevents excess scar tissue from forming along the wall of the treated arterial segment.
The IN.PACT Admiral drug-coated balloon received the CE mark in 2009 but remains an investigational medical device in the U.S., where it is under review by the U.S. FDA.
Medtronic’s application includes data that it says demonstrates superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularization) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease.
Now the wait begins for the company, with final approval quite likely to take up to two years from the point of submission.
“The introduction of drug-coated balloons in the U.S. for the treatment of peripheral artery disease in the SFA is highly anticipated as a new standard of care for this difficult to treat condition, especially due to the consistently strong clinical data we’ve witnessed with IN.PACT Admiral,” said John Laird, M.D., co-principal investigator of IN.PACT SFA, and interventional cardiologist, U.C. Davis Medical Center, Calif. “The IN.PACT Admiral clinical program has raised the bar for the industry, and may reduce the need for traditional interventions as first-line treatment, such as metal stents, which are not ideally suited for this dynamic artery.”
“This exciting milestone keeps us on track for FDA approval of the IN.PACT Admiral drug-coated balloon in the U.S. in early FY16,” reaffirmed Tony Semedo, president of Medtronic’s endovascular therapies business. “More than 1,000 patients have been enrolled in the studies submitted to the FDA. The breadth and depth of our clinical program is unparalleled in the treatment of femoropopliteal disease across both randomized, controlled trials and real-world studies.”
Source: Medtronic, Inc.