Mumbai, Maharashtra, India – Business Wire India Release Summary First study designed to assess immediate results & healing patterns in two different time frames of 3 and 6 months from implantation.
Only study that documents the OCT healing parameters of ultra-thin strut stents larger than 3.00 mm.
SMT (Sahajanand Medical Technologies Limited) today announces publication of EverOCT study in CCI (Catheterization and Cardiovascular Intervention) journal evaluating 3 & 6 months results of its EVERolimus-eluting Coronary Stent, *Tetrilimus by OCT analysis. This is the first and only study to assess the immediate results and healing pattern in two different time frames.
EverOCT was a prospective, multi-centre, single-arm, and investigator-initiated study performed at seven Indian sites between January 2017 and September 2018. OCT evaluations were done on 57 patients who underwent Tetrilimus stent implantation. Follow-up OCT was scheduled at 3 months for first 16 patients and at 6 months for 41 patients. Primary outcomes included degree of strut coverage, malapposition and thickness of neointimal hyperplasia (NIH) over covered struts.
Presently there is no available data pertaining to the healing pattern of everolimus coated ultra-thin struts (60 μm). This is the only study that documents the OCT healing parameters of ultra-thin strut stents larger than 3.00 mm. Tetrilimus has the ultra-thin strut thickness (60 μm) for the entire size matrix (2.0 to 4.5 mm diameter).
EverOCT study was aimed to evaluate healing response at strut-level and cross-section level of new everolimus-eluting ultra-thin stent (60 μm) with biodegradable polymer, by means of serial OCT analysis at 3 and 6 months after implantation.
61 Tetrilimus stents were implanted to treat 59 lesions in 57 patients. Paired (baseline and follow-up) OCT data was available for 12 patients and 30 patients at 3 and 6 months, respectively. At 3 months, rapid early healing was indicated by 95.48% covered struts per lesion with very low (0.11 ± 0.06 mm) NIH. At 6 months, NIH accumulation was greater (0.21 ± 0.07 mm) as compared to 3 months. 99.77% of struts per lesion were covered at 6 months.
Data regarding >3.00 mm diameter stents were unique as the comparative data showed that there was no significant difference in coverage of stents, eccentricity index and NIH thickness over the struts as compared to ≤3.00 mm diameter stents. Tetrilimus portrays uniform expansion and concentric apposition over the vessel wall.
Speaking more about the publication and study, Dr Upendra Kaul, the principal investigator, and Chairman and Dean of the Batra Heart Research Centre, Delhi said, “EVEROCT is a unique study showing very efficient early healing process which is just right in thickness and complete coverage for the continued long-term efficacy. It gives high level of confidence to reduce the intensity of potent dual antiplatelet therapy in high bleeding risk patients which are seen frequently in clinical practice.” The conclusion of the EverOCT study demonstrated rapid early healing of ultra-thin Tetrilimus with nearly complete endothelization within 3 months and at 6 months accompanied with low accumulation and uniform distribution of neointimal hyperplasia.
About Tetrilimus Ergonomically designed Tetrilimus (Everolimus Eluting Coronary Stent System) is unique 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. Tetrilimus portrays uniform expansion and concentric apposition over the vessel wall.
About SMT SMT (Sahajanand Medical Technologies Limited) is a global developer and manufacturer of minimally invasive cardiovascular devices including coronary, structural heart and occluders devices. SMT continues to upgrade its product portfolio to cater to the healthcare needs. SMT has a global presence, and it has received recognitions from the Ministry of Health Sciences & Technologies for its contributions in the field of Coronary healthcare. SMT is committed to advance the patient care by introducing quality medical devices to serve patients. SMT has acquired Vascular Concepts Limited in the year 2020.
*Tetrilimus is a trademark of Sahajanand Medical Technologies Limited or its affiliates.
To View the Image, Click on the Link Below: Tetrilimus (Everolimus Eluting Coronary Stent System) PWR PWR