Alvimedica Launches 46-mm Cre8 DES in Europe

March 20, 2015—Alvimedica recently announced European CE Mark approval for its 46-mm Cre8 polymer-free Amphilimus-eluting stent system for the treatment of very long blockages in the vessels with coronary artery disease. 

The device is an addition to Alvimedica’s product line addressing complex coronary artery disease. The 46-mm Cre8 device leverages the technology and clinical outcomes of the Cre8 drug-eluting stent with a longer-length device. The use of a single stent in long lesions, instead of multiple stents, may result in several procedural benefits, noted the company.

The company also noted that the 46-mm Cre8 device is supported by clinical evidence obtained with the Cre8 drug-eluting stents, including randomized trials and all-comers studies. The efficacy of the Cre8 polymer-free Amphilimus-eluting stent has been demonstrated in the overall population and in a prespecified diabetic subgroup. The Cre8 clinical program aims to show data consistency in diabetic patients, stated Alvimedica.

Cre8 is available in diameters ranging from 2.25 to 4.5 mm and now with lengths ranging from 8 to 46 mm.

According to Alvimedica, the Cre8 device includes abluminal reservoir technology that provides consistent drug loading onto the stent platform, thus enabling controlled and directed elution exclusively targeted to the vessel wall. The device’s Amphilimus formulation consists of sirolimus plus an organic acid, which is designed to enhance drug bioavailability and drug distribution to the entire vessel wall. The bio-inducer surface is a second-generation integral pure-carbon coating that has demonstrated excellent results in terms of stent endothelization and strut coverage, stated the company.