CORCYM Announces the First Patient Enrolled in MANTRA Study
CORCYM, the new, independent, medical device company dedicated to providing patients and cardiac surgeons with the best solutions to fight structural heart disease, announces today the enrollment of the first patient in the MANTRA study. MANTRA (Mitral, Aortic aNd Tricuspid post-maRket Study in a reAl-world setting) is a prospective, multi-arm, multi-center, global, post-market clinical follow-up study that monitors the safety and performance of the complete CORCYM portfolio in a real-world setting.
“The MANTRA study has been designed leveraging the umbrella study concept, as it contains a master protocol with endpoints applicable across the treatment options together with additional sub-studies for specific devices and dedicated endpoints. MANTRA currently contains three sub-studies: an aortic study, a mitral and tricuspid study, and a third study fully dedicated to the Memo 4D annuloplasty ring,” explained Prof. Bart Meuris (University Hospital Leuven, Belgium) Coordinating Investigator of the MANTRA aortic sub-study and part of the MANTRA Steering Committee together with Prof. Serdar Günaydın (Ankara City Hospital, Turkey), Prof. Jörg Kempfert (Deutsches Herzzentrum Berlin, Germany) and Prof. Patrizio Lancellotti (University Hospital Liège, CHU Sart Tilman, Belgium).
The first patient was implanted in Italy, at Città di Lecce Hospital with a Bicarbon aortic mechanical valve, which has been CE mark approved for use with low-dose anticoagulant therapy in low-risk patients1. Conducted worldwide, the MANTRA study is planned to enroll 1,750 patients in approximately 100 centers with follow-up to 10 years.
“We are glad to take part in the MANTRA study and to have started enrolling patients in its aortic sub-study. As a primary endpoint, we will verify the device success at 30 days as defined by the VARC guidelines2. Study patients will be followed-up annually to 10 years to assess the device safety and performance, together with the patient quality of life,” reported Dr. Giuseppe Santarpino, Principal Investigator at Città di Lecce Hospital, Italy.
“The launch of the MANTRA study confirms CORCYM’s commitment to continuously generate new clinical evidence in collaboration with cardiac surgeons to help them treat patients better today and in the future,” commented Christian Mazzi, CORCYM CEO.
About CORCYM
CORCYM is a global, independent, medical device company entirely focused on state-of-the-art surgical solutions to fight structural heart disease. CORCYM has a presence in more than 100 countries with approximately 850 employees and ensures strong continuous support to patients, healthcare professionals and healthcare systems worldwide. For more information, please visit www.corcym.com
___________________________
References:
- INR range 1.5-2.5 in patients at low risk for thromboembolic events undergoing single mechanical aortic valve replacement, as demonstrated by Torella et al., Am Heart J; 160:171-8, 2010.
- VARC: Valve Academic Research Consortium (Généreux, et al. 2021 Eur Heart J, 42(19):1825-1857).
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210716005014/en/
Contact information
For media information:
Marina Curci, CORCYM Communication
communication@corcym.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 15:59:00 EEST | Press release
Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac
Frost & Sullivan Recognizes Novotech as 2025 Global Biotech CRO Company of the Year3.7.2025 15:05:00 EEST | Press release
In recognition of its innovation, client-focused delivery, and global impact, Novotech has been awarded the 2025 Global Biotechnology Contract Research Organization (CRO) Company of the Year by Frost & Sullivan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703950144/en/ Novotech Wins Global CRO Award Novotech is a globally recognized full-service clinical CRO and scientific advisory firm, trusted by biotech and small- to mid-sized pharmaceutical companies to advance their drug development programs at every phase. With a global footprint spanning Asia-Pacific, North America, and Europe, Novotech supports over 5,000 clinical trial sites and a distributed team of experts delivering seamless, end-to-end solutions across geographies. “Novotech is redefining biotech-focused clinical research through AI-driven innovation, global expansion, and a client-embedded partnership model. With a clear vision to be the CRO of choice for
Tinnitus Research: Novel Compound AC102 Makes Constant Ear Noise Disappear in Preclinical Model3.7.2025 13:02:00 EEST | Press release
The novel compound AC102 almost completely reversed tinnitus in a preclinical model after a single dose. At the same time, the damaged connections between the auditory nerve and inner ear sensory cells were restored. These findings were recently published in the prestigious International Journal of Molecular Sciences in a joint study conducted by Erlangen University Hospital and Berlin-based drug developer AudioCure. As there is currently no causal treatment for tinnitus, there is a high medical need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702168211/en/ In 10-20% of tinnitus cases, the noise in the ear is so severe that it significantly impairs the quality of life of those affected. (Source: AI-generated) In the current study, AC102 was administered to the middle ear of one experimental group after acoustic trauma, while a second group received a placebo. Although both groups initially showed signs of tinnitus, th
H2SITE Secures EIC Accelerator Funding to Deploy a Flagship 1 TPD Ammonia Cracker Using Membrane Reactor Technology at a Port in North-West Europe3.7.2025 09:40:00 EEST | Press release
H2SITE has been awarded the EIC (European Innovation Council) Accelerator program for a project aimed at deploying a first-of-its-kind ammonia cracking unit capable of producing 1 ton of high-purity hydrogen per day. The system is based on H2SITE’s proprietary palladium-based membrane reactor technology, which enables the simultaneous catalytic decomposition of ammonia and selective hydrogen separation within a single unit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702142283/en/ Ammonia Cracker using Membrane Reactor Technology This breakthrough technology offers several compelling advantages over conventional ammonia cracking processes: Lowest Levelized Cost of Hydrogen (LCOH) from ammonia due to high efficiency and integrated operation Reduced energy consumption, operating at significantly lower temperatures (400–450 °C) than traditional cracking methods (typically 600–800 °C) High-purity hydrogen output, compliant
ISDA and Ant International Lead New Industry Report on Use of Tokenised Bank Liabilities for FX Settlement and Cross-Border Payments Under Project Guardian3.7.2025 09:00:00 EEST | Press release
The International Swaps and Derivatives Association (ISDA) and Ant International led the Project Guardian FX industry group to develop a new report for implementing tokenised bank liabilities and shared ledger in cross-border payments and foreign exchange (FX) settlement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702791535/en/ Report on Use of Tokenised Bank Liabilities for Transaction Banking by ISDA and Ant International, under the Monetary Authority of Singapore's (MAS) Project Guardian The joint report is produced under the Monetary Authority of Singapore's (MAS) Project Guardian, a global collaboration between policymakers and key industry players to enhance liquidity and efficiency of financial markets through asset tokenisation. ISDA and Ant International are members of the industry group and lead the FX workstream to develop FX data specifications, risk management frameworks and FX documentation. Other contri
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom