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Coimbatore
Clinical trials of new stent from SMT begin
September 18, 2017
City-based GKNM Hospital is one of the six centres selected by Sahajanand Medical Technologies (SMT), India’s largest manufacturer of cardiovascular medical stents, for carrying out clinical trials for its EverOCT-Tetrilimus Optical Coherence Tomography (OCT) study in the country, for its new stents.
EverOCT (Evaluation of the Tetrilimus EVERolimus Eluting Coronary Stent) by OCT study aims to evaluate the malapposition, degree of strut coverage and vessel wall response after implantation of the bio-degradable polymer coated Tetrilmus Everolimus-eluting stent by OCT analysis, the company Senior Vice-President, Sales (India), Sanjay Raina told reporters here on Monday.
This would also be compared with the Quantitative Coronory Analysis of the angiograms done at the time of OCT, he said adding that 50 patients will be selected for the study, with eight patients already in GKNM Hospital.
Commenting on the study, senor consultant interventional cardiologist at GKNM Hospital Dr. Rajpal K Abhaichand said that he had taken eight patients including two female for the study to measure the perfect thickness of the stent, which will not not allow tissue to grow after the implantation, leading to problem like re-block for the patients.
Stating that the trials have begun from March last and the patients are perfectly alright, without any complications, Rajpal said that the only robust way to evaluate a new medicine was by doing properly designed clinical trials.
Both Raina and Dr. Rajpal said that so far 38 patients were taken for trials across the country and once the study of 50 patients completed, the stent, costing about Rs.30,000 will be in the market in a big way for the benefit of the patients.
“After the study, we hope to achieve a remarkable breakthrough which will set a benchmark for others to follow.The analysis will help Indian medical companies to compete with the international companies in the Cardiovascular spare and thereby providing affordable health care for the masses through this cutting edge technology,” Rajpal said.
