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:
Mike Feher
mike.feher@cath.works
Media:
Sarita Monico
sarita.monico@cath.works
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