ART: Bucking the Trend in Bioabsorbable Stents
Bioabsorbable stents arouse great enthusiasm among both interventionalists and industry executives, because they have one major advantage over current stents, both bare metal and drug-eluting: they obviate the need for a permanent implant when only a temporary scaffolding effect is needed. Many stent companies are hedging their bets, working on stents that incorporate both drug elution and bioabsorbability--but not Paris-based Arterial Remodeling Technologies, which is arguing that natural healing, not drug therapy, is the best approach to therapeutically active stents.
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REVA Medical started almost 14 years ago as a bare metal stent company, only to run into the drug-eluting stent (DES) revolution. In response to the DES boom, the company reinvented itself as a bioresorbable stent company and then added a drug-eluting capability. However, until the late-stent thrombosis risk of DES emerged in 2006, bioresorbable stents were largely irrelevant. REVA has survived the ups and downs of the device financing environment by adopting creative solutions, including an evolving relationship with a strategic partner and ultimately an Australian IPO. The company is just now reentering the clinic with its pivotal trial, which is both a testament to its perseverance and a sign of the many challenges still ahead, not the least of which being whether REVA’s innovation will ultimately be rewarded.
The safety profile of drug eluting stents appears to be improving with second and third-generation designs that utilize thinner struts (which are believed to reduce vessel injury and turbulent blood flow) and minimize or eliminate the polymer coating. However, many researchers in this field believe the future of stenting will be defined by completely biodegradable stents that do their job of propping open the vessel until healing occurs, and gradually degrade over a period of months or years, leaving nothing permanently behind in the vessel.
Growth by innovation is almost considered a birthright in interventional cardiology, and based on presentations at this year's Transcatheter Cardiovascular Therapeutics meeting, held this September in San Francisco, it seems clear that innovation still reigns supreme in this specialty. However, as in other medical device markets, ongoing economic and regulatory pressures are taking their toll, particularly in the drug-eluting stent market, as the field adjusts to a new era of cost control and economic uncertainty.