Keystone Heart this week said it won CE mark approval for its TriGuard 3 Cerebral Embolic Protection device. TriGuard 3 is designed to reduce the risk of cerebral damage by deflecting debris from cerebral circulation during trans catheter aortic valve implantation and other transcatheter heart procedures, according to the company. “Even with increased operator experience […]
Keystone Heart inks distribution agreement with Vasorum
Keystone Heart has started distributing Ireland-based Vasorum’s Celt ACD vascular closure device in the U.S. and Europe, effective this month. Approved by FDA in 2016, the Celt ACT is a biocompatible implant meant to close femoral artery punctures taking place after catheterization. Health providers have implanted the CeltACT in more than 40,000 patients to date. […]
Venus Medtech completes Keystone Heart merger
Chinese transcatheter heart valve maker Venus Medtech said today that it closed its merger with Keystone Heart. Privately-held Keystone Heart sells TriGuard embolic protection devices that are designed to protect the brain during transcatheter aortic valve replacement and other cardiac procedures. Hoping for FDA approval in the third quarter of 2019, Keystone Heart is enrolling patients […]
Venus Medtech to acquire Keystone Heart
Chinese heart valve maker Venus Medtech said today it inked a deal to acquire cerebral embolic protection device maker Keystone Heart for an undisclosed amount. Tampa, Fla.-based Keystone Heart developed and produces TriGuard embolic protection devices, which are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce […]
Keystone Heart launches new TriGuard embolic protection study
Keystone Heart said today it launched the second phase of its Reflect trial evaluating the safety and efficacy of its third-generation TriGuard cerebral embolic protection device. In the trial, investigators will explore the use of the TriGuard 3 and its ability to protect a patient’s brain from emboli during transcatheter aortic valve replacement procedures, the […]
Venus Medtech inks exclusive TriGuard 3 deal with Keystone Heart
Chinese heart valve maker Venus Medtech said yesterday it inked a partnership deal with Keystone Heart through which Venus will gain exclusive rights to develop and sell a third-gen version of Keystone’s TriGuard 3 device in China and other Asian markets. The deal builds on a partnership between the two companies announced last March to promote Venus’ […]
Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year. The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of […]
Keystone Heart, Venus Medtech ink Asian TAVR stroke partnership deal
Keystone Heart and Chinese heart valve maker Venus Medtech said today they inked a partnership deal covering China and other Asian markets. Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device. TriGuard is a cerebral embolic protection device designed to reduce the amount of […]
Keystone Heart touts TriGuard cerebral protection data in TAVR patients
Keystone Heart today released data from transcatheter aortic valve replacement patients treated with its TriGuard cerebral embolic protection device, touting a significant reduction in brain lesions. TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR procedures, by allowing blood to pass […]
TAVI: Good early data for Keystone Heart’s TriGuard
Data from a trial of Keystone Heart‘s TriGuard anti-stroke device showed a lower rate of neurologic deficits after transcatheter aortic valve implantation, according to research presented last month at EuroPCR 2015 in Paris. The 85-patient Deflect 3 study found that TAVI patients treated with the Israeli company’s TriGuard, which is designed to allow blood to […]
ACC 2015 Roundup: CTA no benefit, Abbott’s MitraClip, Philips’ IntelliSpace
A large clinical trial comparing computed-tomography angiography with functional testing found no benefit to clinical outcomes with CTA, which also exposes patients to large doses of radiation.
