Terumo : Aortic Announces PMDA Approval for Thoraflex Hybrid in Japan
July 04, 2023 at 06:40 am IST
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July 04, 2023
Terumo Aortic today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval of the Thoraflex Hybrid Frozen Elephant Trunk (FET) device for commercial sale in Japan for the treatment of patients with complex aortic arch disease.
Thoraflex Hybrid is the global market leader in Frozen Elephant Trunk (FET) repair and has well established clinical outcomes.
Thoraflex Hybrid is a single use medical device combining a Gelweave polyester graft with a Nitinol self-expanding stent graft and is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta in cases of aneurysm and/or dissection.
Kotaro Yoshida, Senior Vice President of Asia Pacific added: "The PMDA approval of Thoraflex Hybrid is a fantastic opportunity for Terumo Aortic in Japan. This innovative hybrid device complements our open surgical graft and endovascular portfolio currently available in Japan; the approval of this device will contribute significantly in the delivery of our commitment to providing solutions for every aorta."
Thoraflex Hybrid received CE Mark approval in 2012 and FDA approval in 2022 with more than 13,000 devices sold around the world. This device is integral to Terumo Aortic's market-leading portfolio of surgical, endovascular and hybrid devices to treat every segment of the aorta.
About Terumo Aortic
At Terumo Aortic, we partner with our customers to revolutionize aortic care. We deliver innovation, versatility and precision with the broadest range of solutions that can be personalised for every patient. We are further complementing our implantable device portfolio through the development of digital technologies.
Notes to Editors
Terumo acquired Vascutek Ltd. in 2002 and Bolton Medical Inc. in 2017
Terumo Aortic has over 1,250 employees around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.
Terumo Corporation published this content on 04 July 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 July 2023 01:09:06 UTC.
Terumo Corporation specializes in the design, manufacturing and marketing of medical products and equipments. Net sales break down by family of products as follows:
- cardiac surgery devices (53.5%);
- medical products for hospitals (28.6%): medical devices, nutritional additives, oxygen, medical measuring devices (thermometers, tensiometers, glucometers, etc.), etc.;
- sanguine transfusion equipments (17.9%).
Net sales break down geographically as follows: Japan (32.9%), America (29.5%), Europe (19.6%), China (7.4%) and other (10.6%).
TERUMO CORPORATION 
