Meril Life Sciences' LANDMARK trial, highlighting the safety
and effectiveness of the Myval Transcatheter Heart Valve Series,
stands out as a key late-breaking trial at EuroPCR 2024. The trial
involving 768 patients across 31 sites underscores Meril's
dedication to research and patient well-being.
VAPI, India, May 15, 2024
/PRNewswire/ -- Exciting news from Meril Life Sciences! The
LANDMARK trial's 30 days primary outcomes were presented on 15th
May at EuroPCR 2024, Paris,
France. LANDMARK was recognized by EuroPCR as one of the top
three late breaking trials poised to transform current practices in
the field of Interventional Cardiology.
The LANDMARK study showed that the performance of Myval THV
series in terms of safety and effectiveness was non-inferior to the
contemporary THV series (24.7% vs. 27.0%, occurrence of primary
composite endpoint which is composite of deaths, stroke, major
bleeding, acute kidney injury, major vascular complications,
moderate or severe valve regurgitation, and the need for new
permanent pacemaker implantation as per the third Valve Academic
Research Consortium consensus) with no difference in the itemized
components of the primary composite endpoints. The other secondary
endpoints including technical success at exit from procedure room,
device success at 30 days and early safety at 30 days were
comparable in both the groups.
Professor Serruys, Chairman & study director of the LANDMARK
trial, said "Myval THV series are novel next-gen THV devices;
non-inferior to the Sapien and Evolut THV series. Myval THV series
have a unique size matrix incorporating conventional, intermediate
and extra-large diameters with increasing diameter steps of 1.5mm
that match and fit precisely the multi slice CT scan-defined aortic
annulus area of each individual patient, as a result, provides a
superior effective orifice area on echocardiography, which may
impact on durability and long-term clinical outcomes. Additionally,
the Myval Octacor, with its 2 rows of octagonal cells and a minimal
foreshortening of 19% during expansion, has unique features not
paired by any other contemporary design."
Myval THV series has a versatile range of sizes offering not
only traditional sizes (20 mm, 23 mm, 26 mm, 29 mm) but also
intermediate (21.5 mm, 24.5 mm, 27.5 mm) and extra-large sizes
(30.5 mm and 32 mm). This tailored sizing matrix allows
cardiologists to select the appropriate valve size, thus avoiding
excessive over- or under-sizing. In the LANDMARK trial, 48.1% of
the patients were implanted with the intermediate size of Myval THV
series.
The hemodynamic outcomes in terms of valve effective orifice
area (EOA) was significantly better for the 23, 26 and 29 mm Myval
THV series as compared to Sapien THV series, while there were no
significant differences in the pre-procedural annular area. The
long-term benefits of the intermediate sizes of THV will be further
studied during the subsequent follow-up up to 10-year.
As per the Global Principal Investigator, Prof. Andreas Baumbach, "The Landmark trial showed
that the Myval THV series performed as safe and effective as
contemporary THV series. It is a valve made for everyday clinical
practice and an all-comers population. The special feature of
intermediate diameters allows for more accurate sizing, which has
the potential to translate into improved long-term outcomes. Our
patients will be followed up for 10 years and it will be
interesting to see the long-term results in the three treatment
arms."
Mr. Sanjeev Bhatt, Sr. Vice
President - Corporate Strategy at Meril said, "In a successful
development in structural heart interventions, the LANDMARK RCT has
revealed compelling results for the novel Myval transcatheter heart
valve (THV) series, confirming its non-inferiority to other
contemporary THV devices. The results of LANDMARK trial are not
just a win for us but for the entire medical community and, most
importantly, for patients undergoing TAVI. This study not only
reinforces the safety and efficacy of the Myval THV series but also
highlights its adaptability to challenging anatomical
structures".
About THE LANDMARK TRIAL:
The LANDMARK trial was a prospective, randomized, multicenter,
open-label, non-inferiority trial involving 768 patients who
underwent Transcatheter Aortic Valve Implantation (TAVI) for the
treatment of aortic stenosis. The first patient was enrolled in the
LANDMARK trial on 6 January 2021 and
the last patient was enrolled on 5 December
2023. The trial included a total of 768 patients at 31 sites
across 16 countries (Brazil,
New Zealand, and some countries of
Europe). The 30 days primary
composite endpoints reporting the safety and effectiveness of
LANDMARK trial is accepted for publication in The Lancet.
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 wholly-owned
subsidiaries in the USA,
Brazil, Australia, Asia, Africa
and Europe.
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
centre for medical device innovation and production.
More To Life!!
View original
content:https://www.prnewswire.co.uk/news-releases/meril-announces-successful-primary-outcomes-of-next-gen-myval-thv-series-in-major-rct-presented-at-europcr-2024---earns-prestigious-late-breaking-trial-status--the-lancet-acceptance-302145200.html