Stentys announced that it is discontinuing enrollment in its Apposition V trial for its bare metal stent and focusing its resources and money on its next-generation sirolimus-eluting stent featuring a new delivery catheter.
The company said it made the decision because of recently published articles that have accelerated the trend toward treating patients with a type of severe heart attack (referred to as STEMI) with drug-eluting stents. Stentys said the trend is especially strong in the U.S. and resulted in slow enrollment in the Apposition V trial in the country, which could have endangered its PMA application.
"This decision to terminate enrollment in the study was made in close collaboration with the study's Steering Committee. We are affirming our plan to invest the Company's financial resources where we can make the greatest positive impact on a patient's health in the future and be best positioned to take a leading share of this dynamic market," said CEO and co-founder Gonzague Issenmann in a statement.
In June the French company acquired assets relating to a new catheter delivery technology with the acquisition of Delaware's Cappella Peel Away. Stentys touts its self-expanding stents' vessel conformability, which it says minimizes malapposition, or the separation of the stent from the vessel wall. It sells paclitaxel-eluting and bare metal stents in Europe, but only the bare metal version has FDA approval for sale in the U.S.
Now it aims to add a drug-eluting product to its U.S. stable. The choice of sirolimus to replace paclitaxel reflects growing evidence that limus-based drugs are superior at preventing heart complications. In 2013, Biotronik also shifted its clinical-stage bioresorbable (and drug-eluting) stent from paclitaxel to a limus-based drug.
While drug-eluting stents replaced bare metal stents as the standard treatment around 2006, the market for simpler stents still has a pulse, and not just in cost-conscious emerging markets. Boston Scientific ($BSX) received a PMA approval for its Rebel bare metal stents last month. Boston says some patients are not eligible to receive drug-eluting stents.
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