Alvimedica announces the approval for its Cre8™ & Cre8™ EVO DES to be implanted with just 1month DAPT duration when clinically indicated.
July 30, 2019 – ALVIMEDICA announces to have received the CE regulatory approval for its Cre8™ & Cre8™ EVO Drug-Eluting Stents (DES) to be implanted with just 1 month of Dual AntiPlatelet Therapy (DAPT) duration when clinically indicated.
While physicians should adhere to DAPT duration defined into the current ESC (2017 and subsequent updating) or ACC/AHA/SCAI Guidelines for PCI, the decision to interrupt or discontinue DAPT is the responsibility of the treating physician, taking into consideration the individual patient’s condition (e.g. non-deferrable surgery). Guidelines details on indications and modalities for DAPT interruption are available in the ESC or ACC/AHA/SCAI organizations’ websites (https://www.escardio.org/; https://www.acc.org/; https://www.heart.org/; http://www.scai.org).
In case unanticipated interruption or discontinuation of DAPT is required any time after one month following Cre8™ products family implantation, one-year clinical data of Cre8™ products family indicate low stent thrombosis rates and no observed increased risk for stent thrombosis.
It is well known that despite DAPT guidelines for patients who receive DES generally recommend daily compliance for up to 6 or 12 months, some of them interrupt or discontinue their DAPT earlier for a variety of reasons. These patients are often the most complex, and DAPT interruption exposes them to possible severe adverse events which are minimized thanks to the unique and innovative technologies embedded into Alvimedica Cre8™ product family.
The CE approval for just 1month of DAPT duration with Cre8™ & Cre8™ EVO applies to those products distributed in all the countries that accept CE mark. This is further strengthening the solid clinical track record of the entire Cre8™ product portfolio. Alvimedica, today, can offer physicians a more extensive treatment coverage for all those patients with coronary artery disease that are at high risk of bleeding and, as a consequence, need particular care.
Leyla Alaton, president of Alvimedica, commented: “In Alvimedica we continue taking the challenge to develop devices that answer the real everyday clinical un-met needs. The CE approval for a short DAPT duration following PCI with Cre8™ witnesses how beneficial our exclusive technology is for all those patients looking for the next level of innovation in DES”.