Sorin Group (MIL:SRN), the largest European cardiovascular company and world leader in medical technologies for cardiac surgery, announced today the first patient enrolment in the e–OPTIMA registry. The e–OPTIMA registry is designed to assess the clinical performance of the Sorin Group OPTIMA Drug–Eluting Stent (DES) Carbostent in the treatment of real–world patients in routine clinical practice. The OPTIMA DES features a specially designed delivery system that allows for optimal DES expansion at implant. The registry will involve 1,000 patients throughout the world (except in the U.S. and Japan).
Patients with multiple stenoses in multiple vessels will be allowed in the e–OPTIMA registry, thus making it a real–world registry.
The primary endpoint of e–OPTIMA is the incidence of adjudicated composite rate of cardiac death, myocardial infarction (MI) and clinically–driven target lesion revascularization (TLR) at 6 months (device–related endpoint). Other major secondary endpoints are duration of dual antiplatelet therapy and thrombosis rate up to 2 years, measurement of late lumen loss at 8 months (in a sub–group population). Data consistency and reliability will be obtained through 100% on–line and 10% (randomly performed) on–site monitoring together with an independent adjudication of any adverse events.
"The e–OPTIMA registry will allow us to further confirm the unmatched safety profile provided by the Sorin Group DES technology with a reduced dual antiplatelet therapy as well as assess the OPTIMA DES long term efficacy", said Dr. J. Koolen (Catharina Hospital, Eindhoven, The Netherlands), the Principal Investigator of e–OPTIMA. "It has been demonstrated that when increased attention is paid in optimizing DES implantation, its clinical safety and efficacy are enhanced thanks to improved stent strut wall apposition. The OPTIMA innovative delivery system was specifically designed to address this need," he added.
About the OPTIMA stent
The Sorin Group´s OPTIMA new–generation DES system offers the unique combination of patented polymer–free drug reservoir and the proven anti–thrombotic and potentially pro–healing integral CarbofilmTM coating. The innovative delivery system has been designed to improve device deliverability and optimize DES expansion.
OPTIMA provides the following key benefits:
- OPTIMA has no polymer to carry the drug (Tacrolimus, a cytostatic drug produced by Astellas), thus eliminating the shortcomings often associated with polymers;
- OPTIMA utilizes a proprietary drug–release system with reservoirs on the stent´s outer surface, ensuring targeted release only towards the vessel wall;
- OPTIMA virtually eliminates the risk of thrombosis with its CarbofilmTM coating technology;
- OPTIMA allows for a limited period of dual antiplatelet therapy duration, thus reducing the life–threatening bleeding risks a forced prolonged dual antiplatelet therapy may induce in some patients;
- OPTIMA allows for a precise DES positioning due to the two highly visible markers at both DES ends and non–foreshortening design;
About Sorin Group
The Sorin Group (www.sorin.com), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology, and the treatment of chronic kidney diseases. At the Sorin Group, more than 4,000 employees work to serve over 5,000 public and private treatment centers. Every year, over 1 million patients are treated with the devices of Sorin Group in more than 80 countries.
For more information, please visit: www.sorin.com
