Peer-Reviewed EuroIntervention Journal Publishes First-in-Human Study Finding Filterlex Medical's CAPTIS® Embolic Protection Device Performed Well and is Safe During Transcatheter Aortic Valve Replacement (TAVR).
CAESAREA, Israel, Nov. 15, 2023 /PRNewswire/ -- Filterlex Medical Ltd., a cardiovascular medical device startup, announced today the publication of a first-in-human (FIH) study in the peer-reviewed cardiovascular journal, EuroIntervention. The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.
TAVR is an emerging minimal invasive alternative treatment to surgery in patients with aortic stenosis. The increased risk in peri-procedural stroke is the result of calcified heart valve or tissue particles that break loose and travel in the bloodstream towards the brain. In the published study, the CAPTIS® system captured a high number of embolic debris particles, providing embolic protection and enhancing safety during TAVR procedures.
The study, which included 20 patients undergoing TAVR procedures with the CAPTIS® device, demonstrated a 100% success rate in the use of the device. TAVR procedures were completed with no device-related complications, and most significantly, no cerebrovascular events.
Giora Weisz, MD, CMO of Filterlex Medical, remarked, "The positive outcomes and strong performance of the CAPTIS® device in a clinical setting showcased in the EuroIntervention publication are indeed encouraging. This study sheds light on the capability of the CAPTIS® device to deliver neurovascular and systemic embolic protection, crucial for lowering the risk of stroke and other embolic events during TAVR procedures. It also highlights its promise for improving patient outcomes in other complex cardiac procedures."
The easily-deployed CAPTIS® device is securely positioned in the aorta, protecting its surface, while facilitating a seamless TAVR procedure – all performed uniquely without needing additional arterial access.
Filterlex Medical continues to pursue the development and clinical investigation of the CAPTIS® device, aiming to substantiate its use in TAVR and other left-heart procedures.
Filterlex Medical Ltd. is a cardiovascular medical device startup developing CAPTIS®, a full-body embolic protection device. In 2016, Filterlex joined Alon MedTech Ventures incubator, owned by Dr. Shimon Eckhouse, a leading entrepreneur and investor. The company's founders have vast clinical knowledge and extensive experience in medical device development, commercialization, and marketing. For more information: www.filterlex.com.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 881076.