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SMT announces completion of patient enrolment of EverOCT Trial


SMT announces completion of patient enrolment of EverOCT Trial

Mumbai: SMT has announced the enrolment completion of EverOCT – Tetrilimus Optical Coherence Tomography (OCT) Study.

EverOCT study aims to evaluate the mal-apposition, degree of strut coverage and vessel wall response by OCT analysis after implantation of the biodegradable-polymer coated Tetrilimus Everolimus-eluting stent (EES). This would also be compared with the Quantitative Coronary Analysis (QCA) of the angiograms done at the time of OCT in a corelab.

The study has been conducted under the leadership and principal investigator Prof Upendra Kaul. Dr Kaul is one of the pioneers in the interventional cardiology space in India. OCT analysis will be conducted at Cardiovascular Research Centre (CRC), under the direction of Dr. Alexandre Abizaid, (MD, PhD), Chairman of CRC and Director, Interventional Cardiology Institute of Dante Pazzanese de Cardiologia, São Paulo, Brazil.

“We look forward to seeing the conclusive outcomes of the EverOCT trial. We expect it will confirm the promising results we have seen so far. This Study involved enrolments of 57 patients at 7 sites spread across 5 states of the nation. We thank all the study collaborators for their support in recruiting patients.” said Prof Kaul, Principle Investigator of the EverOct Trial.

“We reiterate our position that Evidence Based Medicine will always be at the core of SMT’s product development strategy. EverOCT study puts us one step forward. Our vision is to be the therapy leader in cardiac interventional devices space while striving to bring innovative medical devices which will provide better therapy solutions.” added Mr Piyush Savalia, Sr. V.P. Clinical Trial, SMT.

He further says that “We leverage a decade-long healing experience while bringing the best of efficacy and safety outcomes offered through SMT DES.”

Tetrilimus is the 4th Generation stent system from SMT and the trend set by SMT has been followed by several players in the industry, owing to the clinical benefits of this innovative shift from the conventional durable polymers to biodegradable polymers. In collaboration with leading interventional cardiologists and researchers worldwide, SMT offers comprehensive range of innovative medical devices to address the cardiovascular treatment needs.

About Tetrilimus

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 it’s data has been published in various reputed indexed journals.



Source: Press Release
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