Search
Close this search box.

News

Terumo Aortic Announces US FDA Breakthrough Device designation for Thoraflex Hybrid device

Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its innovative Thoraflex Hybrid stented device for complex aortic arch repair.

The purpose of the FDA’s Breakthrough Device Designation program is to fast-track the regulatory review process for certain medical technologies and device-led combination products that satisfy certain criteria; these include providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The aim of the program is to provide patients and healthcare professionals with timely access to important breakthrough medical devices by accelerating their development, assessment and review, while preserving the statutory standards for premarket approval and 510(k) clearance.

Thoraflex Hybrid is a single use medical device combining a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft and is indicated for the surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta.

Advanced age, smoking or genetic inheritance may result in the aortic wall weakening and bulging which can lead to a ruptured thoracic aortic aneurysm (TAA). TAA rupture remains a significantly fatal condition with most patients only surviving for 6 hours if there is no surgical intervention. Another condition is aortic dissection where a tear develops in the vessel wall; should either occur the artery may rupture and only 1 in 5 patients survives.

Joseph Coselli, MD (Professor, Vice Chair and Chief, Division of Cardiothoracic Surgery, Baylor College of Medicine, Houston, Texas, US) the principal investigator for Thoraflex Hybrid commented: “This breakthrough designation from the FDA 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 instead of the conventional treatment involving two procedures thus lowering the risk of patient mortality and potentially reducing overall operating time and hospital costs.”

John Canning, Chief Technical Officer with Terumo Aortic added: “The announcement from the FDA is very encouraging and we look forward to close collaboration with the FDA to advance treatment options for patients suffering from this deadly disease.”

Thoraflex Hybrid is the latest innovation within Terumo Aortic’s market-leading portfolio of surgical, endovascular and hybrid devices to treat every segment of the aorta. Thoraflex Hybrid became the world’s first multi-branched “frozen elephant trunk” prosthesis when it received CE Mark approval in 2012.

Latest news

Contact us

Click the button below to get in touch. For more updates, follow us on X and LinkedIn. You can also view our VuMedi channel. 

Latest news

Subscribe for Email Updates

Your subscription could not be saved. Please try again.
Please check your email to confirm your subscription.

Subscribe to our regular email news to keep you updated on the latest information and events from Terumo Aortic.

We use Brevo as our marketing platform. By clicking below to submit this form, you acknowledge that the information you provided will be transferred to Brevo for processing in accordance with their terms of use

REGISTRATION FORM

AATS - Hands on Training - Registration

Personal Details

Thoraflex Hybrid Product Overview - Delivered Andrew Easton & Ryan Martin.

Sunday 28th April: 09:00 - 09:30
Session 1 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Adaptability & Versatility of Thoraflex Hybrid - Pedro Catarino, MD.

Sunday 28th April: 12:15 - 13:15
Session 2 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Thoraflex Hybrid Product Overview - Delivered Andrew Easton & Ryan Martin.

Sunday 28th April: 15:45 - 16:15
Session 3 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Thoraflex Hybrid Product Overview - Delivered Andrew Easton & Ryan Martin.

Monday 29th April: 09:15 - 09:45
Session 4 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Thoraflex Hybrid - The Canadian Experience - Michael Chu, MD.

Monday 29th April: 12:15 - 13:15
Session 5 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Disclaimer:
We collect your personal information for the sole purpose of managing event attendees and ensuring the smooth operation of the AATS event. Your data will not be used for marketing purposes unless you have explicitly signed up for updates or promotional materials.

REGISTRATION FORM

Charing Cross - Hands on Training - Registration

Personal Details

Fenestrated TREO Demo - Lukasz Siudmiak

Tuesday 23rd April: 10:30 - 11:30
Session 1 Checkbox
Spaces Remaining: 7

This session is now fully booked.

TREO Fit Mini-Symposia - Prof Vladimir Makaloski

Tuesday 23rd April: 13:30 - 14:30
Session 2 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Fenestrated TREO Mini Symposium - Prof Van Herwaarden

Tuesday 23rd April: 15:00 - 16:00
Session 3 Checkbox
Spaces Remaining: 8

This session is now fully booked.

RelayBranch Demo - Lukasz Siudmiak

Tuesday 23rd April: 16:30 - 17:30
Session 4 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Fenestrated TREO Demo - Lukasz Siudmiak

Wednesday 24th April: 10:30 - 11:30
Session 5 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Thoracoflo Mini Symposium - Prof Sabine Wipper

Wednesday 24th April: 13:30 - 14:30
Session 6 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Fenestrated TREO Demo - Lukasz Siudmiak

Wednesday 24th April: 15:00 - 16:00
Session 7 Checkbox
Spaces Remaining: 8

This session is now fully booked.

TEVAR Custom Made Demo - Lukasz Siudmiak

Wednesday 24th April: 16:30 - 17:30
Session 8 Checkbox
Spaces Remaining: 8

This session is now fully booked.

TEVAR Custom Made Demo - Lukasz Siudmiak

Thursday 25th April: 10:30 - 11:30
Session 9 Checkbox
Spaces Remaining: 8

This session is now fully booked.

Disclaimer:
We collect your personal information for the sole purpose of managing event attendees and ensuring the smooth operation of the AATS event. Your data will not be used for marketing purposes unless you have explicitly signed up for updates or promotional materials.