First-in-Human Use of ProtEmbo® Cerebral Protection System in EU Trial

German device company Protembis GmbH, tells us about the first clinical applications of its ProtEmbo® Cerebral Protection System to complement a transcatheter aortic valve replacement (TAVR) procedure.

Background

Protembis describes its ProtEmbo® Cerebral Protection System as the next-generation cerebral-focused embolic protection device (EPD). It is an intra-aortic filter device that deflects embolic material arising during transcatheter aortic valve replacement (TAVR) away from the brain. The claim is that it not only minimizes the risk of cerebrovascular events related to TAVR, but also many other interventional and surgical procedures.

The ProtEmbo® device is delivered using a low-profile (6Fr) guiding sheath, via the left radial artery. This access route means there is no interference with the TAVR catheter or accessories. The system claims to be simply, quickly and reliably deployed and offers complete coverage of all three aortic side branches. In practice it will deflect micro particles, as tiny as 6o microns, is heparin coating for optimal biocompatibility and suitable for a wide variety of aortic arch anatomies. Find video here.

The first in-human procedure was performed by Darren Mylotte, M.D., and his team at Galway University Hospital, Ireland. He declared the procedure a success, stating that the device was “safe and feasible.”

The ProtEmbo® System was successfully deployed via the left radial artery across all three branches of the aortic arch for the duration of the TAVR procedures. The procedures were conducted under conscious sedation. On completion of the valve implant, the ProtEmbo® System was safely withdrawn without difficulty. None of the patients experienced a stroke event and there were no other device-related adverse events.

The objective of the now-ongoing European trial is to demonstrate the safety and feasibility of the ProtEmbo® System when used to provide embolic protection during TAVR.

Physician comments

Dr Mylotte commented: “Over the next 10 years, TAVR procedures are expected to increase fourfold. With TAVR shifting to younger and lower-risk patients, cerebral protection becomes even more important. Clinical data from two recent studies of intermediate-risk patients undergoing TAVR suggest 30-day stroke risk as high as 5.5%. It is therefore critically important that we have a cerebral-focused protection device that will reduce the frequency of embolic events. The ProtEmbo®System shows tremendous promise in reaching this clinical objective – first-in-human use of the device was safe and feasible.”

Company comments

Conrad Rasmus, who heads Protembis together with Karl von Mangoldt, stated; “Clinically detectable strokes are just a tiny fraction of embolic events that occur in TAVR, and even small infarcts and micro emboli may have adverse long-term effects on brain function. Certainly, we need a simple yet effective way to protect the brain during TAVR, and the ProtEmbo® System is designed to be this solution.”

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