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Home » Keywords » Keystone Heart Ltd.

Items Tagged with 'Keystone Heart Ltd.'

ARTICLES

Illustration of TAVR device

Protembis receives €20M from EIB for cerebral embolic protection system

July 31, 2024
By Shani Alexander
Protembis GmbH received €20 million (US$21.66 million) in financing from the European Investment Bank to develop its cerebral embolic protection system, Protembo. The intra-aortic filter device deflects embolic material away from arteries leading to the brain during left-sided heart procedures including transcatheter aortic valve replacement.
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FDA icons

Keystone fails to wow FDA committee in hearing for Triguard 3

Aug. 3, 2021
By Mark McCarty
Keystone Heart Ltd. had the unusual experience of being the sponsor of a rare class II device appearance before an FDA advisory committee, which considered whether the company’s Triguard 3 device was substantially equivalent (SE) to a predicate device. However, the company’s bid for an SE result was unsuccessful, likely leaving Keystone with a considerable additional regulatory lift before the company can get to market.
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Hands holding brain

Keystone Heart secures CE mark for Triguard 3

March 10, 2020
By Liz Hollis
Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels.
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