Recross Cardio Achieves First Clinical Implantation in PROTEA-PFO Study

Recross Cardio Inc., a structural heart company developing next-generation membrane-based sealing technologies, has completed the first clinical implantation of its novel PFO Sealing System. The milestone took place at Tufts Medical Center, Boston, led by Dr. Carey Kimmelstiel and his interventional cardiology team.

Why This Matters?

Patent Foramen Ovale (PFO) affects roughly one in four adults. For younger stroke patients, it remains a significant and often silent risk factor. While current occluder devices have improved outcomes, physicians still see room for:

• Better long-term sealing
• Improved biocompatibility
• Reduced device footprint
• Faster endothelialization

Recross Cardio aims to push these boundaries with a conformable membrane design intended to elevate the standard of PFO care.

Inside the PROTEA-PFO Early Feasibility Study

The PROTEA-PFO EFS (NCT07172464) is a prospective, multi-center, single-arm trial approved under FDA IDE. Key study details:

• Up to 15 patients
• Five U.S. centers of excellence
• Evaluating safety and performance of Recross’s membrane-based PFO Sealing System
• Goal: Reduce risk of recurrent ischemic stroke via transcatheter PFO sealing

Physician Insights

Dr. David Thaler

Director Emeritus, Comprehensive Stroke Center, Tufts Medical Center
National Co-Principal Investigator

He highlighted the unmet need:

“PFO is common and a known cause of stroke in younger patients. Current devices have helped, but improved sealing and biocompatibility could push outcomes further. We’re excited to evaluate this membrane-based approach.”

Dr. Carey Kimmelstiel

Director, Interventional Cardiology, Tufts Medical Center
National Co-Principal Investigator

He emphasized ease of use and early performance:

“Delivery was intuitive. Implantation times should match current devices. The membrane design offered a low profile and excellent acute sealing. If preclinical data translate clinically, patients may gain real advantages.”

Company Perspective

Tom Gerhardt, CEO of Recross Cardio, called the first implantation a meaningful milestone:

“Years of development and collaboration led to this moment. We’ll continue rigorous clinical evaluation as we work to make membrane-based technology the new standard in septal sealing.”

The Technology Behind the Platform

Recross Cardio’s device uses a proprietary membrane sealing technology. It is engineered to:

• Overcome limitations of traditional occluders
• Fit seamlessly into existing procedural workflows
• Offer a lower profile and improved sealing performance

What’s Next?

The PROTEA-PFO study will continue enrolling patients across participating centers.
More clinical insights are expected as follow-up data and procedural experiences accumulate.

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