Emboliner provides protection to the full brain and body from ischemic events caused when embolic debris is released into the bloodstream at the time of transcatheter heart procedures. Credit: National Cancer Institute on Unsplash.

Emboline has announced the treatment of the first subject in the Protect the Head to Head investigational device exemption (IDE) clinical trial of Emboliner to reduce stroke risk from transcatheter aortic valve replacement (TAVR).

The patient was treated with the Emboliner Embolic Protection Catheter at New York-Presbyterian Hospital/Columbia University Medical Center in the US.

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Emboliner is said to be the first device to provide full brain and body protection from ischemic events such as stroke caused by the release of embolic debris into the bloodstream at the time of transcatheter heart procedures.

It captures and removes all debris from transcatheter procedures.

The randomised, prospective, open-label, multi-centre, two-arm IDE trial is designed to demonstrate the catheter’s effectiveness and safety against the control device (Sentinel CPS) for patients undergoing TAVR.

It will enrol 500 participants at up to 20 centres across the globe.

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Endpoints of the trial include major adverse cardiac and cerebrovascular events (MACCE), VARC-2 stroke and acute embolic debris captured at 30 days.

Emboline president and CEO Scott Russell said: “In our previous SafePass clinical studies, the Emboliner captured and removed more than five times the clinically relevant embolic particles compared to published data for a commercially available device offering partial brain protection.

“This is consistent with the predicted difference based on arterial blood flow and suggests a significant advantage for patients treated with the Emboliner.”