Growth in devices for lower extremity procedures will be supported by positive clinical data supporting the efficacy of stenting in these indications, the release of new devices designed specifically for peripheral vessels such as the femoral popliteal (fem-pop) and infrapopliteal (infrapop) arteries and demand for minimally invasive alternatives to treat critical limb ischemia, where there has been an increasing focus on saving limbs.
Current penetration of PV stents and PTA balloon catheters in the infrapopliteal artery procedures is fairly low, making it an attractive growth opportunity.
The success of DES in coronary indications has encouraged the development of DES products for these peripheral vessels as well, since coronary stents are often used off-label in this indication. In 2011, Abbott Vascular received CE mark approval for the use of its XIENCE PRIME DES, originally developed for coronary vessels, in infrapopliteal arteries as well. Other companies, like IDEV Technologies have been developing dedicated infrapopliteal PV stents that feature low profiles, greater durability and longer lengths compared to coronary stents. If these companies are able to prove the efficacy of these devices in the infrapop indication, they will likely be able to gain market share through 2016.
"Despite the early clinical promise of DES, adoption has been relatively slow," said MRG Analyst Louise Murphy. "As is often the case, the efficacy of the device is highly dependent on physician familiarity, and many physicians still carry reservations about stent placement in the lower extremities. As a result, drug-coated balloons are also being considered for this indication, and have generated a great deal of industry interest. MEDRAD, Invatec (recently acquired by Medtronic) and Lutonix all have DCBs with CE mark approval. Both DES and DCB products are currently undergoing a number of clinical trials, the results of which will have strong influence on adoption rates."
Millennium Research Group's European Markets for Peripheral Vascular Devices 2012 report includes procedure, unit, average selling price and revenue information, along with market drivers and limiters and competitive landscape for PV stents, PTA balloon catheters, EPDs, aortic stent grafts, synthetic surgical stent grafts and accessory devices sold in France, Germany, Italy and the United Kingdom.