Tough FDA review standards and the novelty of the technology have turned the race to sell the first bioresorbable stent in the U.S. into a marathon. The first CE mark for a bioresorbable stent was granted to Japan's Kyoto Medical Planning in 2007.
As with many other devices, the U.S. lags behind Europe in adoption. Still, the next-generation stents could be marketed in the U.S. as early as 2015. Market research firm GlobalData predicted that by 2018, bioresorbable stents (also known as biodegradable or bioabsorbable stents) will achieve U.S. sales of $319 million and $383 million in 5 large European Union nations, according to a December 2012 report.
To be fair to the FDA, the 2007 CE mark was for a stent for the peripheral arteries, and companies have had plenty of setbacks in CE-mark trials for a bioresorbable stent for the coronary artery. In fact, progress has been slower than GlobalData predicted.
FierceMedicalDevices has selected four companies that are in the running for FDA approval; they have each taken their product beyond the preclinical stage. Two already market bioresorbable stents in Europe, and market leader Abbott ($ABT) is the first and only to initiate clinical trials in the U.S.
Unlike metal stents that stay in the body permanently, bioresorbable stents are designed to degrade into natural materials and be absorbed by the body within two years. They are expected to provide a trio of medical benefits over today's standard of care, drug-eluting stents: a reduction in restenosis, or renarrowing of the arteries, which results from the body's inflammation response to foreign materials; a continued increase in the size of the coronary artery in the months following the surgery (at least in the two CE-marked devices); and the return of vasomotion, or the vessel's reversion to its original, prediseased state.
"If there is a permanent stent in the vessel, the vessel is dependent on the stent to function and can become weak," GlobalData research analyst Priya Madhavan said in one of many interviews with FierceMedicalDevices.
The lack of patient-level outcomes data, concerns about relatively high levels of stent thrombosis (the formation of a blood clot that blocks the stent), and partial to nonexistent government reimbursement explain why bioresorbable stents have a market share of only 5% to 10% in Europe, according to Madhavan. Reimbursement is critical because bioresorbable stents have a list price of $3,000 to $4,000--about twice as much as conventional drug-eluting stents. But if the products deliver on their medical benefits, counterbalancing cost savings will be achieved due to a reduction in revision surgeries to fix implant failure or undesired side effects like restenosis.
France's Arterial Remodeling Technologies (ART) rounds out the companies that are in clinical testing aimed at a CE mark or FDA approval, but little is known about the company's trial other than that it is being conducted with financing from corporate strategic investor Terumo under an agreement signed in March. ART didn't respond to a request for more information.
In addition, a host of small companies have bioresorbable stents in the preclinical stage. Of note is Amaranth Medical, which announced an equity investment from Boston Scientific ($BSX) in January. -- Varun Saxena (email | Twitter)