Dec. 3, 2025 — Recross Cardio Inc., a structural heart company developing next-generation membrane sealing technology, recently announced the first clinical implantation with its novel PFO Sealing system in the PROTEA-PFO Early Feasibility Study (EFS). The procedure was successfully performed by Dr. Carey Kimmelstiel and his interventional team at Tufts Medical Center in Boston, Massachusetts.
The PROTEA-PFO EFS (NCT07172464) is a prospective, multi-center, single-arm study approved under FDA Investigational Device Exemption. The study will enroll up to 15 patients at five U.S. centers of excellence to evaluate the safety and performance of the Recross PFO Sealing system for transcatheter sealing of Patent Foramen Ovale (PFO) to reduce the risk of recurrent ischemic stroke.
Dr. David Thaler, Director Emeritus of the Comprehensive Stroke Center at Tufts Medical Center, Professor of Neurology at Tufts University School of Medicine, and National Co-Principal Investigator of the PROTEA-PFO study, emphasized the clinical importance of the study: "PFO is found in roughly one in four adults and is a recognized cause of stroke in younger patients. Current occluder devices have been transformative in reducing stroke recurrence. There is room to build on these successes through improved sealing, enhanced biocompatibility, or reduced device footprint. We're excited to evaluate this membrane-based approach and its potential to advance care for stroke survivors."
Dr. Carey Kimmelstiel, Director of Interventional Cardiology at Tufts Medical Center, Professor of Medicine at Tufts University School of Medicine, and National Co-Principal Investigator of the study commented on the first-in-human implantation: "It's gratifying to participate in the clinical evaluation of this technology. Delivery was intuitive, and I expect implantation times to be comparable to current devices. The conformable membrane design allows for a low profile that delivered excellent acute sealing. If preclinical findings hold, faster endothelialization could provide meaningful advantages for patients."
Tom Gerhardt, CEO of Recross Cardio, added: "This milestone reflects years of hard work with world-class clinical partners. This is just the beginning. We remain committed to rigorous clinical evaluation as we advance our mission of making membrane-based technology the new standard in septal sealing."
Recross Cardio has developed a disruptive septal sealing device platform based on proprietary membrane technology. The platform is designed to address limitations of current occluders while preserving procedural workflows physicians rely on.
October 08, 2025 
