Meril revolutionizes structural heart care with Myval Octapro THV launch at GIS E and PCR London Valves 2024

Meril Life Sciences, a leading global med-tech company specializing in cardiovascular and structural heart solutions, marked a significant milestone with the launch of its Myval Octapro Transcatheter Heart Valve (THV) at GISE 2024 (National Congress of the Italian Society of Interventional Cardiology) and PCR London Valves 2024. These esteemed scientific events provided an ideal platform for Meril to showcase its commitment to advancing structural heart care. 

The Myval THV series, known for its innovative contributions to transcatheter aortic valve replacement (TAVR) procedures, continues to set new benchmarks with the Myval Octapro THV. This latest iteration introduces low frame foreshortening, enhancing operator control and enabling precise deployment for improved procedural predictability. Additionally, its comprehensive size matrix, which includes conventional, intermediate, and extra-large valve sizes, ensures optimal valve selection tailored to diverse patient anatomies. 

Speaking on this achievement, Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril Life Sciences, stated: "The positive reception of the Myval Octapro THV at these global platforms underscores our commitment to delivering cutting-edge solutions for severe aortic stenosis. We are proud to collaborate with clinicians worldwide in advancing TAVR technology and improving patient outcomes through innovation." 

At PCR London Valves 2024, Meril presented key findings from the LANDMARK trial subset analysis and comparative studies, further establishing the safety and efficacy of the Myval Transcatheter Heart Valve (THV) series. Published in EuroIntervention Journal, the findings confirmed the Myval THV’s non-inferiority to both Sapien and Evolut valve series at 30 days post-implantation, solidifying its position as a reliable solution for structural heart interventions. 

The results highlighted comparable composite safety and effectiveness outcomes between Myval and Sapien (24.7% vs. 24.1%), with Myval demonstrating a lower rate of permanent pacemaker implantation (15.0% vs. 17.3%) and superior hemodynamic performance. Similarly, the Myval THV series performed on par with Evolut in composite endpoints (24.7% vs. 30%), while showing advantages in reducing pacemaker implantation rates and moderate/severe valve regurgitation. Effective orifice areas were also comparable between 26 and 29 mm of Myval THV series and Evolut THV series, underscoring its strong performance in key clinical measures. 

The conference also featured the unveiling of the COMPARE-TAVI trial results. Presented by Prof. Henrik Nissen on behalf of the COMPARE-TAVI investigators, this first-of-its-kind randomized controlled trial directly compared the Myval THV series with the Sapien THV series in a real-world, all-comers population. 

Key Findings from the COMPARE-TAVI Trial: 

• Non-Inferiority Demonstrated: The Myval THV series met the non-inferiority criteria for the composite primary endpoint (death, stroke, moderate/severe aortic regurgitation, and valve deterioration) at one year, with comparable rates to the Sapien THV series (13.8% vs. 13.0%, p = 0.02). 

• Reduced Patient-Prosthesis Mismatch (PPM): Myval THV exhibited a significantly lower incidence of PPM compared to the Sapien series (17.5% vs. 28.6%), a critical factor for long-term valve performance and patient outcomes. 

The findings presented at PCR London Valves 2024 underscore the Myval THV series as a transformative option in transcatheter heart valve therapy. With robust data from the LANDMARK and COMPARE-TAVI trials, Myval THV series has demonstrated comparable safety and efficacy to leading alternatives like Sapien THV series and Evolut THV series, while offering distinct advantages in critical areas such as superior hemodynamics, and significantly lower patient-prosthesis mismatch. These results reaffirm Meril’s commitment to advancing structural heart care, providing clinicians with innovative solutions to improve patient outcomes and setting a new benchmark in TAVR technology. 

Meril acknowledges the invaluable contributions of clinicians, partners, and patients in achieving this milestone. With the launch of the Myval Octapro THV, Meril continues its mission of improving lives through pioneering structural heart care solutions. 

About Meril Life Sciences: 

Meril is a leading global medical device manufacturing company based in India that has been pivotal in establishing India as a leader in the global medical devices industry. The company's strong focus on research and development (R&D) and commitment to quality have allowed it to offer cutting-edge medtech solutions in more than 135 countries. Additionally, Meril has a large presence in India with wholly-owned subsidiaries in the USA, UK, Europe, Middle East, Africa, Brazil, South America, Australia & Asia. 

With its strong commitment to innovation and quality, Meril has transformed healthcare in India and created significant footprints across the globe. Through global partnerships and the use of advanced technology, the company prioritizes quality and adherence to international standards, fostering a thriving R&D environment. Meril's efforts have effectively established India as a center for medical device innovation and production.