Stentys, a developer of stents to treat acute myocardial infarction (AMI), has completed the enrollment of the final patient in the Apposition II clinical study, a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in patients with AMI.
According to the study, the Stentys stent is advanced when compared to conventional stents in its self-expanding feature being flexible when implanted and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase.
Stentys claimed that its stent avoids malapposition observed with conventional stents, by being in permanent contact with the vessel wall, which put the patient at risk of potential fatal complications such as implant blockage (in-stent thrombosis).
Corrado Tamburino, study investigator and chair of the cardiology department at Ferrarotto Hospital in Italy, said: “The Stentys stent, once implanted, continues expanding and, in our experience, has provided very good apposition to the wall of the vessel compared to conventional stents. This is important because malapposition is one of the factors causing stent thrombosis.”
Jacques Seguin, professor, chairman and co-founder of Stentys, said: “If the Apposition II study results are positive in September, we will have the indisputable proof of the superiority of the Stentys stent over conventional stents. This will be a significant advance for cardiology because all AMI patients could benefit from it.”
Gonzague Issenmann, CEO and co-founder of Stentys, said: “After receiving European market approval for our two flagship products in the first half of the year, this clinical study will confirm scientifically the efficacy of our solution.
“Since the technological and regulatory risks are behind us, Stentys will now begin a pre-release phase in Europe, giving cardiologists the possibility to use the Stentys stent immediately. Each year, more than 3 million stents are implanted worldwide. This annual market is estimated at $5bn.”