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Source/Disclosures

PUBLISHED BY:

Source:

Press release

Disclosures: Coselli reports consulting for and receiving speaker fees from
Terumo Aortic.

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April 20, 2022
1 min read
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FDA APPROVES THORAFLEX HYBRID DEVICE FOR COMPLEX AORTIC ARCH DISEASE

Source/Disclosures

PUBLISHED BY:

Source:

Press release

Disclosures: Coselli reports consulting for and receiving speaker fees from
Terumo Aortic.
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The FDA approved the Thoraflex Hybrid Frozen Elephant Trunk device for
commercial sale in the U.S. for treatment of adults with complex aortic arch
disease, according to an industry press release.

The Thoraflex Hybrid (Terumo Aortic) is the first of its kind device used in
frozen elephant trunk repair in the U.S.; the device received breakthrough
device designation in 2021 by the FDA.

Source: Adobe Stock

According to the release, 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.

“This approval represents a significant milestone in the treatment of patients
who need total aortic arch replacement and have significant disease of the
descending thoracic aorta,” Joseph Coselli, MD, professor and executive vice
chair of the division of cardiothoracic surgery at Baylor College of Medicine in
Houston, said in the release. “They can now be treated anytime in a single-stage
procedure with this hybrid device rather than two procedures which has been the
conventional pathway in the United States for this group of patients. This, in
turn, has led to lowering the risk of major adverse events by 22.6%, in the
first year, over traditional treatments.”

In the release, Coselli also said the device facilitates secondary interventions
for distal extension and, in the U.S., is designated for use with Terumo
Aortic’s RelayPro NBS device. “This unique labelling aspect provides surgeons
with additional confidence should patients have continued aortic disease
progression,” Coselli said.

Read next
Self-expanding stent for transradial peripheral procedures gains FDA approval
FDA recommends not using AAA stent graft system due to type III endoleaks

Thoraflex Hybrid received CE Mark approval in 2012.


READ MORE ABOUT

united states food and drug administration
aortic disease
stent
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