Alvimedica has announced the company has received CE mark for the Cre8 EVO 2.0mm, a polymer-free Amphilimus-eluting stent.
In a press release, Alvimedica states it is now able to offer more extensive treatment coverage for all those patients with complex coronary artery disease: Cre8 EVO 2.0mm embeds the unique technologies of Cre8 and Cre8 EVO drug-eluting stents (DES), extending their clinical benefits to small vessels up to 2.0mm.
In recent decades, small vessel disease has become more frequent due to a worsening of the clinical profile of the patients undergoing percutaneous coronary intervention (PCI): the population needing DES to treat coronary artery disease is increasingly older, often with diabetes mellitus and other comorbidities. These clinical conditions increase lesion complexity and consequently also the need of implanting DES in coronary arteries smaller than 2.25mm, which is usually the smallest available diameter in a DES coronary portfolio.
The Cre8 EVO small vessel DES has a dedicated design which maximises device performance in this clinical setting. The ultra-thin total stent struts of only 70 micron minimise metal volume in small coronaries, while the dedicated design matches the specific requirements of 2.00mm vessels in terms of device deliverability, conformability to the vessel and mechanical performances. Cre8 EVO for small vessel is a “physician-friendly” device with no compromises. Its unique cell geometry allows this DES to be implanted in challenging conditions like tapered and tortuous vessels that can also involve clinically impactful side-branches.
Leyla Alaton, president and CEO of Alvimedica, comments: “We are taking the challenge to develop devices that answer the real everyday clinical un-met needs in a global scenario. The patient population suffering from coronary disease increases every year, as well as its clinical need may be different according to the clinical conditions, disease location and geographical area. Alvimedica wants to be on the edge of innovation to help providing these patients the safest and most effective solutions”.