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 1month 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”.
We are a global innovator of unique interventional medical devices, committed to continuing the
development and manufacturing of globally recognized and highly innovative product portfolios in
both endovascular and interventional cardiology.
We create the highest quality devices and technologies that answer patients’ un-met needs. Our
teams are spread all around the world, with our main manufacturing plants in Italy and Turkey.
Our driving passion is to improve the quality of life through innovative technology, creating a better
future by investing in both clinical research and product development.
We firmly believe that by working with todays' leading physicians we will create highly effective
solutions that meet today’s real unresolved patient needs. This collaboration is fundamental to us as
a company, in order to present and discuss new treatment options.