Keystone Heart is engaged in the development and manufacturing of cerebral embolic protection devices to help reduce the risk of brain embolization linked with cardiovascular procedures.

Keystone Heart president and CEO Chris Richardson said: “This partnership provides us the unique opportunity to improve the lives of patients undergoing structural heart procedures with cerebral embolic protection and the ability of bringing new cutting-edge therapies into the US & EMEA.”

The Israeli firm primarily concentrates on protecting the brain from emboli to reduce the risk of brain infarcts during transcatheter aortic valve replacement (TAVR), atrial fibrillation ablation and other cardiovascular procedures

The company produces TriGuard 3 product pipeline, which will allow interventional cardiologists, electrophysiologists and cardiac surgeons to protect brain while conducting these procedures.

TriGuard 3 cerebral embolic protection device will help cover all three major cerebral branches to reduce the risk of brain damage during cardiovascular procedures.

The deal will provide Venus Medtechwith international rights to TriGuard 3, which is claimed to be the first cerebral embolic protection device that will offer complete coverage to all brain regions for patients undergoing cardiac procedures.

Venus Medtech co-founder and CEO Eric Z said: “Our transcatheter heart valve systems offer patients life-saving support – acquiring Keystone Heart allows us the opportunity not only to reduce the risk of brain injury during cardiac procedures but establishes our presence in the US and EMEA through which we can introduce our entire portfolio of products.”

At present, Keystone Heart is involves in recruitment of patients in the Reflect trial in the US to assess TriGuard 3 device. The enrolment of patients is expected to be completed in the early part of the first quarter of 2019.

The US Food and Drug Administration is expected to review the TriGuard 3 device in the first half of 2019, while the CE mark approval is expected to be received by the end of this year.

Venus Medtech’s transcatheter aortic valve is said to be the first technology secured approval from the China Food and Drug Administration.