Challenges in diabetic patients

ALVIMEDICA – “Challenges in diabetic patients: EVOlving PCI’s clinical outcome through innovative technology”
June 8th 2017 –

Diabetes Melitus is considered a pandemic issue that is going to increasingly affect the everyday PCI activity of any cath-lab around the world in the near future. Alvimedica Medical Technologies, a leading European company in interventional cardiology, has sponsored a TNT session during EuroPCR specifically focused on all the challenges that a PCI in diabetic patients has to face. This TNT session was titled “Challenges in diabetic patients: EVOlving PCI’s clinical outcome through innovative technology”, and took place on Wednesday 17th of May from 12:30 to 14:00 – Palais des Congrès – Paris.

The diabetes mellitus (DM) population is increasing exponentially and even though there is an increasing number of diabetics entering cath labs for PCIs, 2nd generation DES, as well as all the following generations, have not shown any added efficacy for compared to 1st generation stents – meaning the old Taxus DES. Furthermore there have only been 7 studies dedicated to patients with PCI in DM patients. All of them were made in a much selected population not representing the everyday life in cath-labs; and most of them were done still with 1st generation DES. These problems were all explained during the TNT session by Dr. Banai.

Due to the nature of the diabetic cell and the presence of other hormones specifically in Type2 DM patients, current 2nd generation DES cannot provide in DM patients the same efficacy they provide to NON-DM patients. Cre8™EVO is a stent which has been developed to address all of this. In fact, relying on its unique technologies (patented by Alvimedica), it can provide an added efficacy edge compared to all other DES. Dr Robert Byrne went through these unique features during this TNT session. These technologies allow for Cre8™EVO to be a polymer free stent with an abluminal slow and controlled elution (Abluminal Reservoir Technology) of Sirolimus and Fatty Acid (Amphilimus™ formulation) which helps not only the drug to better permeate the vessel wall, but also to provide higher Sirolimus bioavailability inside the diabetic cell which increases efficacy specifically for Diabetic Patients.

Cre8™EVO is the evolution of Cre8™, a stent which through its clinical program has showcased in a multitude of studies its added efficacy in the Diabetic population. Dr Romaguera presented the multitude of Amphilimus Eluting Stent (AES) studies today available, showcasing the added efficacy in the Diabetic population. Specifically:

Cre8™EVO is not just a DES that provides excellent efficacy. As was showcased in the live case during the TNT session, the stent performance is immaculate. When treating diabetic patients, you often encounter very long and diffused lesions in small and tortuous coronary arteries, and with the unique Cre8™EVO stent architecture (EvenArt), these difficult lesions become easy to cross and treat.

Alvimedica has taken the challenge to bring diabetic PCI clinical outcome to a new level. To do this Cre8™EVO is going to be compared to EES in the large scale Diab8 randomized trial (more than 3000 patients) to prove superior efficacy (TLR) at 1year.

About Alvimedica
Alvimedica is a young, innovative company devoted to developing minimally-invasive 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 invites medical professionals to join its ambitions in creating best medical devices for people around the globe.
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