• - Meril Life Sciences presented 14 studies, nine of which were late-breaking trials
• - The company showcased an immersive Virtual Reality (VR) experience zone for case-based learning at their booth and an innovative training village with 13 hands-on sessions and 12 master class lectures

6 June 2019 – Meril Life Sciences, a medical devices company from India, brought the best of its clinical research in interventional cardiology to EuroPCR 2019 (Paris, France, 21–24 May). The company presented a total of 14 studies, nine of which were late-breaking trials—a record number for Meril at an international congress till date.

The company also showcased VR technology for case-based learning on heart valve replacement procedures at their booth and a brand new dedicated training village with 13 hands-on simulator activities for Meril’s latest innovations as well as 12 master class sessions on coronary, peripheral and structural heart technologies.

“We are truly proud for having nine late-breaking trials and five additional studies accepted at EuroPCR this year,” said Dr Ashok Thakkar, Head Clinical Research at Meril Life Sciences. “This is a record number for our company, which shows our strong clinical research presence at such prominent international congress for the interventional community.”

The late-breaking trials highlighted positive safety and efficacy results of the company’s recently CE-approved products: MeRes100 BRS – The world’s first Thin Strut Sirolimus-Eluting Bioresorbable Vascular Scaffold for the treatment of coronary artery disease, and the Myval THV System for Transcatheter Aortic Valve Replacement (TAVR) of severe symptomatic aortic valve stenosis. MeRes100 BRS demonstrated zero scaffold thrombosis and very low Major Adverse Cardiac Event (MACE) rate in the MeRes-1¹ and MeRes-1 Extend² studies up to three years and two years follow-up, respectively. Myval THV showed 100% acute procedural success and no device-related mortality up to one year follow-up in the MyVal-1 study.³

Additionally, the company presented positive clinical outcomes for:

• Mozec Sirolimus-Eluting Balloon for treatment of de novo lesions in-stent restenosis and totally occluded stenotic portion: at 12 months follow-up, the MOZEC SEB PTCA trial showed 100% clinical and device success.⁴
• Credence Sirolimus-Eluting Bioresorbable Peripheral Scaffold: at six months, the CREDENCE BtK-1 first-in-human trial demonstrated favourable safety and efficacy for the treatment of critical limb ischaemia with primary patency of 94.44%, zero device-related deaths and no scaffold thrombosis.⁵
• BioMime Morph − The world’s first Tapered Sirolimus-Eluting Coronary Stent System for diffused long lesions in coronary arteries: the Morpheus-Global registry demonstrated device and procedural success rates of 98.34%, with the majority of patients (98.96% %) with TIMI 3 flow post-procedure. At six months, the study demonstrated a 96% freedom from target lesion failure .⁶ Additionally, the Morph-India study, undertaken in India, showed similar positive outcomes at six months with 98.4% freedom from target lesion failure. Device and procedural success rates were 99.7%, with the majority of patients (99.5%) with TIMI 3 flow post-procedure.⁷
• BioMime Sirolimus-Eluting stent for the treatment of coronary artery disease: at nine months, the MILES-Global study showed in an all-comer real-world population of coronary artery disease patients a low MACE rate of 2% and zero stent thrombosis.⁸ Additionally, the MILES-UK study, undertaken in the UK, demonstrated remarkably low rates of target vessel failure (2%) and stent thrombosis (0.94%) at 9 months follow-up.⁹

New Meril training village at EuroPCR

A hallmark of Meril Life Sciences is its focus on training with its state-of-the-art training centre near Mumbai, India. It is one of biggest training centres for Med-tech in Asia Pacific. At EuroPCR 2019, the international audience had a chance to experience Meril’s training centre with the training village and an interactive booth at the Palais des Congrès in Paris.

The hands-on training sessions focused on the use of the Myval transcatheter heart valve and the MeRes100 bioresorbable vascular scaffold on simulator models. The didactic sessions focussed on best practice experience sharing, and tips and tricks based discussions run by a leading international faculty.

“When physicians visited the Meril training village, the key takeaways were a very clear understanding of the company’s various vascular intervention technologies and the utility and the right indications for each of them in their practice and a good idea of what clinical data are available for each of those technologies,” said Nikhel Goel, Vice President International Marketing, Meril Life Sciences. “We have been doing this on a large scale in our facility in India, but we realised that it is not possible for everyone to come, hence this was a really great opportunity for us to bring our training expertise to Europe.”

The response at EuroPCR was very encouraging, with approximately 600 physicians visiting the training village. The success at EuroPCR shows the extensive interest in Meril’s world leading technologies. The company intends to scale up its activities at EuroPCR 2020.

References

1. Chandra P. MeRes-1 study: Three-year clinical and two-year multimodality imaging outcomes of thin-strut sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease. Presented at EuroPCR 2019
2. Abizaid A. MeRes-1 Extend study: Imaging and two-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease. Presented at EuroPCR 2019
3. Seth A. One-year clinical outcomes of India’s first indigenously designed and manufactured TAVR system. Presented at EuroPCR 2019
4. Selvamani S. MOZEC SEB PTCA study: Short-term clinical outcomes after treatment of de novo lesions, in-stent restenosis and totally occluded stenotic lesions using sirolimus-eluting balloon. Presented at EuroPCR 2019
5. Someshwar V. CREDENCE BtK-1 study: Six-month clinical outcomes of sirolimus-eluting bioresorbable peripheral scaffold system indicated for below the knee lesions. Presented at EuroPCR 2019
6. Agostoni P. Morpheus-Global study: A multicenter prospective registry of a novel tapered sirolimus-eluting stent for long coronary lesions. Presented at EuroPCR 2019
7. Davidson D. Morph-India study: Safety and performance of the world’s first sirolimus-eluting tapered coronary stent system for long coronary lesions: six-month follow-up. Presented at EuroPCR 2019
8. Hudec M. MILES-Global study: Safety and efficacy of sirolimus-eluting stent system in all-comers real-world population with coronary artery stenosis. Presented at EuroPCR 2019
9. Menown M. MILES-UK study: Nine-month clinical outcomes of biodegradable polymer ultrathin sirolimus-eluting stent in an all-comer UK population undergoing percutaneous coronary intervention