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Drug-Eluting Balloon One Step Closer to FDA Submission as Medtronic Completes Enrollment for IN.PACT Admiral Study
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IN.PACT Drug-Eluting Balloon |
June 3, 2013 -- Medtronic, Inc. (NYSE: MDT) announced today that its IN.PACT Admiral drug-eluting balloon clinical program had reached the enrollment needed to support submission to the FDA for approval to use this novel device in the treatment of peripheral disease, specifically blockages in the superficial femoral artery.
Although the IN.PACT family of drug-eluting balloons (DEB) have been available in Europe for over four years, no drug-eluting balloons have been approved for use in the United States. Medtronic announced that expects to submit the first part of its pre-market approval application to the FDA this summer. But the approval process is lengthy, and the company foresees a late 2015 launch, if the approvals move forward.
Angioplasty of the Leg: A Challenge
Treating peripheral artery disease has proven to be one of the biggest challenges for the interventional cardiologist and radiologist. Although, compared to the coronary arteries, the arteries in the leg tend to be long and straight, and they aren't in a constant state of motion. However, when opened, the peripheral artery has tended to reblock or restenose at a higher rate than the coronaries.
Various types of devices have been tried to alleviate this problems, from shavers (atherectomy devices) to drug-eluting stents, similar to those used in the heart. However, results from atherectomy vary, and stents can be subject to fracture, especially in parts of the leg that are subjected to compression and stress.
To date, the only drug-eluting stent approved for use in the United States has been the Zilver PTX, manufactured by Cook Medical. The Zilver showed excellent results in clinical trials and most recently was recalled for a problem in the delivery system. No announcement has yet been made when the Zilver will be back on the shelves.
The concept of a drug-eluting balloon is attractive because such a device can be used in very narrow diameter vessels, and because no metal device is left in place to fracture or become the nexus for blood clots or excess tissue growth, eventually reblocking the vessel. Whether the DEB will be the solution to the problems encountered in treating peripheral artery disease will be seen as the multi-year results are measured. The IN.PACT clinical program is currently studying over 4,600 patients worldwide, looking at treatments in a variety of vessel locations.
Most recently, Medtronic presented one-year results of its coronary DEB trial, comparing it to the Boston Scientific Taxus stent, for use in the heart. The results: no significant differences at one year between devices, with a numeric trend favoring outcomes in the IN.PACT drug-eluting balloon.
This morning's press release from Medtronic, Inc. follows:
Medtronic Reaches Major Milestone in Clinical Program for 'IN.PACT Admiral' Drug-Eluting Balloon
Company Plans to Submit First Module of U.S. Approval Application for Novel Peripheral Angioplasty Device to FDA Over Summer
June 3, 2013 -- Minneapolis -- Continuing to demonstrate its ongoing commitment to advancing interventional treatments of peripheral artery disease and the evidence to support their adoption, Medtronic, Inc. (NYSE: MDT) announced today that enough patients have been enrolled in its clinical studies of the IN.PACT Admiral drug-eluting balloon to support the company's U.S. regulatory approval submission of the novel angioplasty device, which is designed to treat atherosclerotic lesions in the superficial femoral artery.
In a related development, Medtronic also announced today that it plans to submit the first module of the pre-market approval (PMA) application for the IN.PACT Admiral drug-eluting balloon to the U.S. Food and Drug Administration (FDA) over the summer.
"The IN.PACT Admiral drug-eluting balloon represents a novel angioplasty device from Medtronic that we foresee launching in the United States in late 2015, pending FDA approval," said Tony Semedo, president of Medtronic's Endovascular Therapies business. "It targets atherosclerotic lesions in the superficial femoral artery with a treatment modality that aims to deliver an anti-restenotic drug while leaving nothing behind."
More than 1,000 patients have been enrolled in the IN.PACT SFA I, II, II pharmacokinetics (PK) and Global studies to date. Clinical data from these studies will comprise a significant portion of Medtronic's PMA application to the FDA for the IN.PACT Admiral drug-eluting balloon. IN.PACT SFA I is a European study; IN.PACT SFA II and II PK, both U.S. studies; and IN.PACT Global, an international study being conducted outside the United States.
The ongoing global IN.PACT clinical program includes 29 studies involving more than 4,600 patients at approximately 230 sites worldwide. Through these company-sponsored and physician-initiated studies, Medtronic's portfolio of IN.PACT drug-eluting balloons will be investigated thoroughly for the treatment of arterial disease in a variety of vessel beds. As part of this program, Medtronic is currently enrolling the IN.PACT Global study, a first-of-its-kind, "real-world" evaluation of the company's IN.PACT drug-eluting balloons involving 1,500 patients with femoropopliteal lesions of any length at up to 80 sites worldwide.
IN.PACT drug-eluting balloons feature a proprietary coating called FreePac that is a formulation of paclitaxel and urea, an excipient that facilitates absorption of the drug into the vessel wall. They received the CE (Conformité Européenne) mark in 2008 and 2009 and are available in many countries around the world.
In the United States, the IN.PACT Admiral drug-eluting balloon is limited to investigational use under an investigational device exemption (IDE) granted by the FDA and, like every drug-eluting balloon, is not yet commercially available.
The superficial femoral artery (SFA) runs close to the surface of the upper leg, from the groin to the knee. As a result of its location, the SFA experiences a variety of torsion and compression forces that pose inherent challenges with the use of permanent metallic stents in the treatment of atherosclerosis, which causes the body's arteries to narrow with the accumulation of fatty deposits (called plaque) inside them.
In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology-alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Reported by Burt Cohen, June 3, 2013
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