Alvimedica has announced CE mark in Europe for the Cre8 46mm polymer-free Amphilimus eluting stent system, dedicated to very long blockages in the vessels that supply blood to the heart due to coronary artery disease. Alvimedica now offers physicians additional options for the treatment of patients with complex coronary artery disease. Cre8 46mm leverages the unique technology and clinical outcomes of the Cre8 drug eluting stent in 46mm length.
Physicians use multiple shorter length stents to meet the challenges of treating long blockages in patients with coronary artery disease as conventional stent sizes may not always fully cover the lesion. It has been shown, however, that the use of a single stent instead of multiple stents may result in several procedural benefits.
“The now available Cre8 46mm allows physicians and especially their diabetic patients to benefit from the high efficacy shown in the NEXT randomised trial” said Cem Bozkurt, chief executive officer of Alvimedica. “We believe Cre8 46mm will provide a step forward in making polymer-free drug eluting stent technology available for the widest range of patients”.
Cre8 46mm is supported by clinical evidence obtained with Cre8 drug eluting stents, including randomised trials and all comers studies. The efficacy of the Cre8 polymer- free drug eluting stent releasing Amphilimus has been demonstrated in the overall population and in pre-specified diabetic sub-group. The Cre8 clinical program aims to show data consistency in diabetic patients, result so far not met by any other drug eluting stent.
Cre8 is available in one of the broadest size matrices on the European market, with diameters ranging from 2.25mm to 4.5mm, and now with lengths ranging from 8mm to 46mm.