Back in June we reported that Medtronic had compiled enough clinical data to support the first stage of its foray into the US regulatory process for its IN.PACT Admiral drug-eluting balloon. Now the company has clearly dotted the “i”s and submitted its first module to the U.S. FDA. The novel angioplasty device for treating superior femoral artery(SFA) lesions remains investigational in the United States, despite having been approved and used in Europe since 2008.
Drug-eluting balloons represent a relatively recent addition to the procedural approaches for treating Peripheral Artery Diseases (PAD), which also include atherectomy, balloon angioplasty and stenting. Evidence is mounting that these devices work pretty well and have the added bonus of not leaving a chunk of metal behind.
The IN.PACT drug eluting balloons for peripheral vascular use, were first CE marked as long ago as 2008, and just over a year later the company that developed it, Invatec, was acquired by Medtronic. The devices feature a proprietary coating called FreePac that is a formulation of the antiproliferative drug paclitaxel and the biocompatible excipient urea, which facilitates rapid absorption of the drug into the vessel wall. The concept is based on the premise that the act of opening the vessel is accompanied by deposition of this anti-proliferative coating onto the luminal surface, thereby optimising the outcome of balloon angioplasty.
The ongoing global clinical program of IN.PACT drug-eluting balloons for the treatment of peripheral artery disease in the lower extremities includes 24 studies involving more than 4,200 patients at approximately 230 sites worldwide. A combination of physician-initiated and company-sponsored studies, the program will fully characterize the safety and efficacy of these combination devices in a variety of peripheral vascular beds, including below-the-knee arteries.
Medtronic’s PMA application for the IN.PACT Admiral drug-eluting balloon will include clinical data from the IN.PACT SFA I and SFA II pivotal studies, the IN.PACT SFA II pharmacokinetics (PK) study, and the IN.PACT Global study, which have enrolled a total of more than 1,000 patients to date. Search IN.PACT in the box to the right and you will see the coverage this has received previously, emphasising the importance the company is placing on its device family.
“Pending FDA approval, we remain on track to launch the IN.PACT Admiral drug-eluting balloon in the United States during the second half of calendar year 2015,” said Tony Semedo, president of Medtronic’s Endovascular Therapies business. “In the meantime, we will continue working with leading healthcare providers and researchers around the world to amass clinical and economic evidence to support the global adoption of this innovative medical technology as an important addition to the treatment options for peripheral artery disease in the lower extremities.”
On the face of it this is a good example of the weird and wonderful world of two disparate regulatory regimes. EU vascular specialists are presumably popping these things in daily with alacrity, while in the United States they remain investigational and only now beginning to see over the horizon to full approval. While it’s entirely possible that developer Invatec chose not to resource a foray into the US, what still beggars belief is that the burden of clinical data required to support new owner Medtronic’s submission is so much more onerous than that which supported the CE mark approval. Little wonder US specialists get frustrated when they look over the pond and see devices that they could usefully employ, but which remain out of reach for reasons of regulatory stringency with the monetary consequences that accompanies them.
Source: Medtronic, Inc.