Wednesday May 18th 2016 - Alvimedica Medical Technologies, a leading European company in interventional cardiology, sponsored a TNT session which includes a LIVE case during Euro PCR 2016 titled “PCI in diabetic patients: turning challenges into today's solution”. This session took place on Wednesday 18th of May from 12:30 to 14:00 – Palais des Congrès – Paris.
The session was designed in a way that a challenging PCI in a diabetic patient was the trigger for an exciting discussion on the best way to improve PCI clinical outcome in diabetic patients learning the added efficacy and safety value provided by the unique Amphilimus™ eluting polymer-free DES Cre8™.
Dr. Verheye and Dr. Eeckhout, chairman and co-chairman of the TNT session, have challenged Dr. Tchetche and Dr. Dumonteil, who performed the live case, to explain all the steps and decisions they have taken in best treating an old diabetic patient with multi-lesion disease involving a bifurcation (Medina 1:1:1). The choice of the right devices, the proficiency of the physicians and knowledge of all the techniques have led to an excellent result. The operator utilized POT and TAP techniques to tackle this bifurcation which coupled with the Cre8™ stent, its cell design, radiopaque markers and zero foreshortening resulted in an optimal outcome.
After the live case Dr. Byrne has discussed the efficacy of the “–olimus” drugs in diabetics and how a diabetic patient requires specific technologies in order to overcome the diabetic cell resistance to standard “-olimus” drugs which results in lower efficacy. Cre8TM is the only solution to this issue due to the AmphilimusTM formulation which is a composition of Sirolimus and a Fatty Acid in which the fatty acid acts as a carrier that drastically increases the permeation of the sirolimus drug in the vessel wall and especially in the diabetic population.
Dr. Sardella presented the latest clinical outcomes for Cre8TM in regards to efficacy in diabetic Patients. What comes out of this data is that Cre8TM has very consistent results when it comes to efficacy endpoints for diabetics that are similar to those of the general population and which are not seen in studies done with other Drug Eluting Stents.
- In-stent Late Lumen Loss in Diabetic patients at 6 to 9 months of 0.12, 0.14 and 0.16 in the NEXT, Reservoir and pARTicip8 studies respectively.
- Target Lesion Revascularization at 1 year of 1.4% in both the Investig8 and pARTicip8 studies.
Dr. Stella followed up by claiming that Cre8TM is not just an efficacy oriented stent towards Diabetics, but also a stent which is very safe. This was witnessed during the live case when the patient was administered only 3 months of DAPT following Cre8TM implantation due to a previous history of bleeding. After showing the Demonstr8 study which showed a Cre8TM DES coverage of 99.78% in just 3 months, he then shared with the audience his own experience where consecutive diabetic patients were treated with 3month DAPT with excellent efficacy results and no case of stent thrombosis! He also presented the study design of the on-going ReCre8 study which is an all comer study with 1 month DAPT in elective PCI patients and 12 month DAPT in ACS patients comparing Cre8TM with Resolute.
Dr Colombo, from San Raffaele hospital in Milan, when asked how he sees Cre8 latest clinical data in perspective answered: “If there is a DES able to bring efficacy in diabetics to a new level, this is Cre8. I foresee that this will be proven in the near future.”
Alvimedica is a young, agile company devoted to developing minimally-invasive medical technologies for medical professionals looking for the next level of innovation in the operating room. We firmly believe that working closely with physicians is the best way to improve our product solutions and services; our ‘co-creation approach’ results in an innovative endovascular product portfolio and in a range of products aimed at meeting needs so far unmet in interventional cardiology.
Alvimedica owns unique technologies applied to its products such as dedicated stent designs, pure carbon coating increasing the haemo and bio compatibility and the latest and most advance technologies in the drug eluting stents. Of course we offer world class bare metal stents, guiding, diagnostic and balloon catheters. But Alvimedica also brings you the exclusive polymer-free, balloon expandable DES stent: Cre8™!
Pioneering technology, collaboration and care in the areas of endovascular and interventional cardiology; Alvimedica invites medical professionals to join in its ambitions in creating best medical devices for people around the globe.
For more information on Alvimedica Medical Technologies: www.alvimedica.com