Keystone Heart secures CE Mark for cerebral embolic protection device

Venus Medtech Company Keystone Heart has secured CE Mark for the TriGUARD 3 Cerebral Embolic Protection (CEP) device, which minimises the risk of cerebral complications during transcatheter heart procedures.

Cerebrovascular complications are considered the most feared threats in the Transcatheter Aortic Valve Implantation (TAVI) and other transcatheter heart procedures.

TriGUARD 3 CEP device deflects embolic debris away from cerebral circulation to reduce the chances of cerebral damage during such procedures.

It is the only CE Marked device created to cover and protect all three major cerebral aortic arch vessels.

Furthermore, the device features Nitinol frame and dome-shaped mesh deflector, delivered transfemorally and devised to ‘self-position’ in the aortic arch.

This design enables the device to adapt to different patient anatomies.

Keystone Heart president and CEO Chris Richardson said: “Taking into consideration the devastating impact of stroke, we are pleased to bring this important technology to patients undergoing any transcatheter heart procedure.

“The introduction of the TriGUARD 3 CEP Device in Europe provides physicians with the only commercially available device that is designed to protect all three cerebral vessels.”

In June 2018, the company initiated a pivotal randomised Phase II clinical trial (REFLECT) of its TriGUARD 3 CEP device, intended to assess the safety and efficacy of the device in around 275 patients. It was recently completed by Keystone Heart.

Currently, the company is finalising data analysis to approach the US Food and Drug Administration (FDA) with the marketing application.