NEWPORT BEACH, Calif. and AMSTERDAM, May 13, 2024 /PRNewswire/ -- CathWorks announced today that the CathWorks FFRangio® System is now approved under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR, and fulfills the requirements for CE marking (0344).
European Medical Device Regulation 2017/745 (EU MDR), the new medical device regulation applicable in Europe, replaces the previous Medical Device Directive 93/42/EEC (MDD) regulation. With the introduction of EU MDR, the EU is placing even greater emphasis on safety measures, risk management, post-market surveillance and data collection of medical devices for companies who wish to obtain European market access.
"The requirements of EU MDR are much more rigorous, sometimes compelling medical device manufacturers to rethink their commercialization strategy in Europe. We are very pleased to have successfully met the rigorous EU MDR requirements and believe this significant milestone underscores CathWorks' steadfast commitment to quality and patient safety. This approval is perfectly timed for the full European launch of our co-promotion partnership with Medtronic that will be in full display this week at EuroPCR," said Ramin Mousavi, President and Chief Executive Officer of CathWorks.
The CathWorks FFRangio technology will be featured prominently at the annual EuroPCR conference taking place May 14 to 17 at the Palais des Congrès in Paris, France. Several scientific sessions will focus on the FFRangio System, demonstrating its growing role in transforming how patients with coronary artery disease are diagnosed and treated.
During a Late-Breaking Trials and Hotline session on Tuesday, May 14, Dr. Yuetsu Kikuta from Fukuyama Cardiovascular Hospital will present his abstract entitled FFRangio-based PCI were associated with better 1-year clinical outcomes in an international registry. The following day, Dr. Kazuhiro Dan from Ichinomiyanishi Hospital will present his abstract entitled Comparison between FFRangio sizing tool and IVUS imaging measurements for PCI.
CathWorks, together with Medtronic as part of the strategic partnership between the two companies, is pleased to co-sponsor a symposium on Thursday afternoon entitled CathWorks FFRangio – Enhancing patient care led by Dr. Rasha Al-Lamee from Imperial College London and Dr. Ajay Kirtane from Columbia University Irving Medical Center. Along with a world-renowned faculty, they will discuss how FFRangio can be seamlessly adopted in everyday practice and aid in clinical decision making for patients with coronary artery disease.
In addition to CathWorks' strong presence on the podium, the latest generation of the FFRangio application will be showcased in the Medtronic booth where attendees can get a hands-on demonstration.
ABOUT CATHWORKS
CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence (AI) and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit www.cath.works and follow @CathWorks on Twitter and LinkedIn.
CathWorks and FFRangio and all affiliated logos are trademarks of CathWorks.
Investors:
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Media:
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