Stentys has announced it received CE marking for its sirolimus-eluting stent. The CE marking will allow the company to market its sirolimus-eluting stent in Europe immediately and, starting in 2015, in the other countries where the company has commercial activity.
The CE marking approval was based on the excellent outcomes of the APPOSITION IV clinical study, in which the Stentys sirolimus-eluting stent demonstrated best-in-class efficacy and faster healing compared to balloon-expandable stents in patients treated for a severe heart attack.
Gonzague Issenmann, chief executive officer and co-founder of Stentys, states: “Stentys finally has a drug-eluting stent from the ’limus’ family of compounds as requested by the interventional cardiology community.”
“In a global coronary stent market that has seen renewed growth and will reach $7bn by the end of the decade, unmet patient needs are driving the market towards specialty stent solutions. Stentys sirolimus-eluting self-apposing stent is the only product that can guarantee complete and continuous apposition in patients with varying vessel anatomy, including in the acute setting, for a safer and more efficacious treatment,” adds Issenmann.