U.S. Peripheral Vascular Stent Market Heating Up

New participants in the peripheral vascular (PV) stent market are focusing on device innovation, transforming the competitive landscape, according to Millennium Research Group (Toronto, Canada), a provider of strategic information to the health care sector.

The PV stent market, previously dominated by only a handful of manufacturers, is quickly changing as newer competitors launch innovative products targeting high-growth segments. A key focus in innovation is strong physician interest in treating peripheral artery disease (PAD)--particularly in femoropopliteal arteries--through minimally invasive means. In the past, many physicians used biliary stents off-label in these arteries, but this practice has come under scrutiny due to insufficient results with previously available stents, resulting in the U.S. Department of Justice launching investigations into the off-label marketing of biliary stents for vascular use.

The incidence of PAD in the United Sates is expected to be driven by rising rates of obesity, diabetes, and end-stage renal disease. Among the innovations introduced to treat PAD are the heparin-coated Viabahn covered stent for use in the superficial femoral artery (SFA), developed by Gore (Newark, Dl, USA), which was approved in 2009 by the U.S. Food and Drug administration (FDA). Competition is expected to further intensify upon the release of a drug-eluting stent (DES) called Zilver PTX, a product of Cook Medical (Bloomington, IN, USA), which is expected to be the first DES approved for peripheral indications in the United States.

"Many PV firms are focusing on developing devices to treat the arteries in the lower extremities, most notably the superficial femoral artery, due to overwhelming pressure from physicians for minimally invasive treatment options that prevent lower limb amputation," said MRG senior analyst Stephanie Labelle.

PAD, also known as peripheral vascular disease (PVD), or peripheral artery occlusive disease (PAOD), includes all diseases caused by the obstruction of large arteries in the arms and legs. PAD can result from atherosclerosis, inflammatory processes leading to stenosis, an embolism or thrombus formation that causes either acute or chronic ischemia. In the United States, PAD affects 12-20% of those aged 65 and older; but despite its prevalence and cardiovascular risk implications, only 25% of PAD patients are undergoing treatment.

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