Cardiovascular medical device startup Filterlex Medical has reported positive data from its CAPTIS full-body embolic protection device in a first-in-human (FIH) study.
The next-generation CAPTIS device is designed to lower the risk of stroke as well as other problems during left-heart procedures. It can be deployed and retrieved easily and intuitively.
With a distinctive, triple-action design, the device deflects, captures and removes embolic particles while providing full-body embolic protection.
The device is implanted in the aorta, preserving its surface while allowing a smooth Transcatheter Aortic Valve Replacement (TAVR) procedure. It needs no extra access and does not disrupt the procedure workflow.
Using the CAPTIS embolic protection device, 20 patients underwent a successful TAVR procedure in the prospective, single-arm study.
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The findings demonstrated that the device was deployed and retrieved successfully in all patients. Furthermore, the procedure was performed without any disruption.
Filterlex Medical co-founder and CEO Sigal Eli said: “We are extremely encouraged by the study and will continue to build robust clinical evidence around the CAPTIS embolic protection device to support its use in TAVR.”
The company noted that there were no device-related complications and that patients did not experience cerebrovascular events.
The European Union’s Horizon 2020 research and innovation programme provided funding for the project.
Wolfson Medical Center Interventional Cardiology head and study principal investigator Haim Danenberg said: “Safe and effective brain protection in percutaneous heart procedures is a true unmet need – I am very impressed with the promising CAPTIS technology. Filterlex has developed an innovative solution that protects TAVR patients’ brain and kidneys.”