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July 5, 2022

Terumo announces first Thoraflex device implant in US

Thoraflex Hybrid FET received CE Mark approval in 2012 and FDA clearance in April.

Terumo Aortic has announced the first commercial implant of the Thoraflex Hybrid frozen elephant trunk (FET) device in the US.

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Thoraflex Hybrid FET combines a Gelweave polyester graft and Nitinol self-expanding stent graft.

The single-use medical device is designed for the open surgical repair or replacement of aortic arch artery vessels that are damaged or diseased as well as for repair of the descending thoracic aorta with or without involving the ascending aorta.

In 2012, the device received CE Mark approval, followed by FDA clearance in April.

Terumo Aortic had sold more than 13,000 Thoraflex Hybrid FET devices worldwide over the last ten years.

Terumo Aortic North America president Paul Kuznik said: “This commercial implant represents a significant milestone for the company and a tremendous opportunity for Terumo Aortic in the United States.

“This innovative hybrid device complements our open surgical graft and endovascular portfolio, making us one of the strongest medical device companies within the aortic space, helping to deliver our commitment to provide solutions for every aorta.”

The Thoraflex Hybrid study principal investigator professor Joseph Coselli, executive vice-chair of the Cardiothoracic Surgery Division at Baylor College of Medicine US, implanted the device.

Coselli said: “The procedure was very successful, the device performed well, and the patient is making a good recovery.

“Thoraflex Hybrid is the first of its kind device used in FET repair in the United States and it will allow US physicians to treat patients who may be at great risk of rupture with a device that brings the primary benefit of requiring a single-stage procedure for those with suitably limited disease, instead of two procedures which has been the conventional pathway in the United States for this group of patients.”

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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