Promising results with the CORACTO stent
|
The European Association of Percutaneous Cardiovascular Interventions held from May 19th to 22nd in Barcelona, Spain was a great success for all of us. The Euro PCR09 congress was attended by over 10.000 visitors from all over the world.
At the beginning of 2009, Alvimedica decided to conduct a research with CVPath and its head officer Prof. Virmani. On May 16th, we received an email including the draft results of the research and Prof. Virmani was kind enough to present the results of her study at our booth and share her knowledge with us. Here is an overview of her study:
|
Prof. Renu Virmani Prof. Renu Virmani is the Medical Director of CVPath Institute, International Registry of Pathology located in Gaithersburg, MD, USA. Virmani is recognized as one of the most acclaimed leaders in the research for diagnostic and treatment therapies for Vulnerable Plaque. Furthermore, she is Clinical Professor at Department of Pathology in Georgetown University, University of Maryland-Baltimore, Uniform University of Health Sciences, and Vanderbilt University. She is also an active lecturer and has authored over 300 publications in peer-reviewed journals in the field of atherosclerosis and vulnerable plaque, stents, and other cardiovascular diseases. Prof. Virmani received honorary awards including the Joint Service Commendation Medal for Outstanding Meritorious Service as Chief of Cardiovascular Pathology, Armed Forces Institute of Pathology (1979 - 1981). Prof. Renu Virmani is a member of the American Heart Association and U.S. & Canadian Academy of Pathology, and is a Fellow of the American College of Cardiology. |
|
CEO of ALVIMEDICA, Cem F. Bozkurt says: "We are delighted with the results of the study showing effective endothelialization in animals and we are very happy to be working with Professor Virmani on this study. We are equally pleased to be working with Professor Reifart on the CTO study and we are confident that our product range will provide our customers with what they need for a successful intervention!" |
CV Path The mission of CVPath Institute, Inc. is to provide expert consultative and research services to strengthen public understanding of cardiac and vascular diseases in order to advance the care of patients with such diseases. The research team at CVPath focuses primarily on the study of atherosclerosis, sudden cardiac death, myocardial ischemia, valvular heart disease, and interventional treatments. The principal goal of the CVPath Institute is to provide histopathology and diagnostic services for clinicians, cardiologists and pathologists seeking to evaluate and improve the efficacy of stents and other interventional cardiovascular devices. A major research interest of CVPath is the characterization, imaging, and treatment of fatal atherosclerotic plaques, a primary cause of death in the Western World and, increasingly, in Asia and the third world. The Institute also provides consultative support for the testing of vascular stents aimed at decreasing neointimal growth and restenosis and incidence of late in-stent thrombosis. |
And Alvimedica hosted Prof. Renu Virmani for at least a couple of hours.
ALVIMEDICA started operating in 2007 and it embodies Europe’s largest clean-room in its facility located in Istanbul, Turkey. The company manufactures bare metal stents, drug-eluting stents and guiding, diagnostic, angiographic and balloon catheters.
The company recently announced the exciting results of their pre-clinical studies conducted on the endothelialisation of CORACTO®: its Rapamycin (Sirolimus)-eluting stent, coated with PLGA- a totally bio-absorbable polymer. The study conducted by Prof. Renu Virmani used confocal, scanning electron and light microscopy to examine re-endothelization and inflammation over 14 and 28 days comparing a BMS (Bare Metal Stent) versus a SES (Sirolimus-Eluting Stent (Alvimedica’s CORACTO®)) and an EES (Everolimus-Eluting Stent) on a healthy rabbit iliac model. The study was not powered for significance but the results showed that endothelial coverage of CORACTO within a period of 14 days was better than that of both EES and SES (Figure 1). As expected, the BMS showed the greatest endothelial coverage.
: Statistically different from control, ANOVA and Dunnett post hoc test (CORACTO as control).
Maturation of endothelial cell junctions identified by immunofluorescent staining of CD31/PECAM-1 shows more percentage of endothelial cells positive for CD31/PECAM-1 between struts in CORACTO than the ESS and SSS, and similar trend noted for coverage above struts (Figure 2). Taken together, CORACTO DES shows improved endothelial coverage with a greater percentage of mature endothelial cells relative to ESS and SSS.
CORACTO offers a platform with better deliverability, and the polymer avoids lifetime usage of antiplatelet therapy and reduces risks of thrombus formation, while maintaining an effective drug platform. The data obtained from the previous studies showed that the bio-absorbable polymer degrades within two months.
ALVIMEDICA have also conducted trials with Professor Reifart from Bad Soden on approximately 100 patients diagnosed with CTO. The 24-month follow-up results showed zero cases of stent thrombosis and a little late loss.