Mumbai: SMT (Sahajanand Medical Technologies Pvt. Ltd.) India’s largest manufacturer of cardiovascular medical stents, has announced the enrolment of the first patient in EverOCT – Tetrilimus Optical Coherence Tomography (OCT) Study.
EverOCT (Evaluation of the Tetrilimus EVERolimus-eluting Coronary Stent by Optical Coherence Tomography) study goal is to evaluate the malapposition, degree of strut coverage and vessel wall response after implantation of the biodegradable-polymer coated Tetrilimus Everolimus-eluting stent (EES) by OCT analysis. This would also be compared with the QCA analysis of the angiograms done at the time of OCT.
The study is being conducted under the leadership of Dr Upendra Kaul who will be the principal investigator. He is a recipient of esteemed B. C. Roy award and was also conferred with the prestigious civilian award from the President of India. OCT analysis will be conducted at Cardiovascular Research Centre (CRC), under the direction of Alexandre Abizaid, MD, PhD, who is the Chairman of CRC and Director, Interventional Cardiology of Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
Commenting on the study, Mr Piyush Savalia Sr. V.P. Marketing & Clinical Trial, SMT said “Evidence Based Medicine is at the core of SMT’s product development strategy. We are committed to nurture the meaningful innovations that deliver better patient outcomes. Here we leverage a decade long healing experience while bringing the best of efficacy and safety outcomes offered through SMT DES, Tetrilimus, the 4th Generation stent system from SMT.”
SMT is the pioneer to bring DES with biodegradable polymers. The trend set by SMT was followed by several players in the industry, owing to the clinical benefits of this innovative shift from the conventional durable polymers. In collaboration with leading cardiac interventionists, researchers worldwide, SMT offers the comprehensive range of innovative medical devices to address of cardiovascular treatment needs.
Ergonomically designed Tetrilimus (Everolimus Eluting Coronary Stent System) is unique in a way for its ultrathin conformal and proprietary biodegradable Polymeric coating (Polymer Matrix -PLLA, PLCL and PVP) which is designed to deliver the drug in a biphasic manner: an initial burst dose, followed by a controlled release of the drug which reduces late adverse clinical events.
The strut thickness of Tetrilimus is 60µ which is lowest among all the predicate devices without compromising the radial strength. These features along with flexible Long Link connector; enhance vessel wall conformability, improve deliverability and extend the reach to more distal and tortuous lesions.
Long term favourable clinical outcomes of SMT DES have been well supported by robust, ICH-GCP Compliant clinical trial program which has covered more than 12, 000 patients till date and its data has been published in various reputed indexed journals.