Recross PFO Sealing System Early Feasibility Study Commences 

December 8, 2025—Recross Cardio Inc., a structural heart company developing next-generation membrane sealing technology, announced the first clinical implantation of the Recross patent foramen ovale (PFO) sealing system in the PROTEA-PFO early feasibility study (EFS).

According to the company, the PROTEA-PFO EFS is a prospective, multicenter, single-arm study approved under an FDA investigational device exemption.

The study will enroll up to 15 patients at five United States centers of excellence to evaluate the safety and performance of the Recross device for transcatheter sealing of PFO to reduce the risk of recurrent ischemic stroke, noted Recross Cardio.

Carey Kimmelstiel, MD, and David Thaler, MD, serve as National Coprincipal Investigator of the PROTEA-PFO study.

Dr. Kimmelstiel is Director of Interventional Cardiology at Tufts Medical Center, Professor of Medicine at Tufts University School of Medicine. Dr. Thaler is Director Emeritus of the Comprehensive Stroke Center at Tufts Medical Center, Professor of Neurology at Tufts University School of Medicine. in Boston, Massachusetts.

“It’s gratifying to participate in the clinical evaluation of this technology,” commented Dr. Kimmelstiel, who performed the first-in-human procedure in the study. “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.”

Dr. Thaler added, “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.”