Recross Cardio achieves first implant of their novel membrane-based PFO sealing system in a US Early Feasibility Study — advancing a new approach to stroke prevention.
April 10, 2026
10
min read
By
bioaccess® Team
**Key Takeaways**
- • Recross Cardio completed first PROTEA-PFO implant in December 2025 at Tufts Medical Center
- • FDA IDE-approved US Early Feasibility Study (NCT07172464)
- • Up to 15 patients at 5 US centers for stroke prevention
- • Novel membrane-based PFO sealing with lower profile design
- • Dr. Carey Kimmelstiel performed the first implant procedure
**The short answer**
Recross Cardio completed the first implant of its novel membrane-based PROTEA-PFO sealing system in December 2025 at Tufts Medical Center (Dr. Carey Kimmelstiel), under an FDA IDE-approved early feasibility study (NCT07172464) enrolling up to 15 patients at 5 US centers. The lower-profile transcatheter system targets recurrent ischemic stroke prevention in PFO patients. Structural heart sponsors often run first-in-human studies in Latin America before progressing to US EFS.
What is the PROTEA-PFO trial for stroke prevention?
Recross Cardio, a structural heart device company, has developed the PROTEA-PFO — a novel membrane-based patent foramen ovale (PFO) sealing system designed to prevent recurrent ischemic stroke. A PFO is a small hole between the upper chambers of the heart that is present in approximately 25% of adults and is associated with an increased risk of cryptogenic stroke.
The PROTEA-PFO system represents a new approach to PFO closure, using a membrane-based sealing mechanism with a lower profile design compared to existing nitinol-based occluder devices currently on the market.
Who performed the first implant at Tufts Medical Center?
In December 2025, Dr. Carey Kimmelstiel performed the first PROTEA-PFO implant at Tufts Medical Center in Boston, Massachusetts. Dr. Kimmelstiel is a respected interventional cardiologist with extensive experience in structural heart procedures, making him an ideal investigator for this first-in-human application of the technology.
How does the novel membrane-based PFO sealing technology work?
The PROTEA-PFO differentiates itself from existing PFO closure devices through its membrane-based approach:
- Membrane-based sealing mechanism — different from traditional nitinol disc occluders
- Lower profile delivery system for improved procedural ease
- Designed for more complete PFO sealing to reduce residual shunting
- Potential for reduced erosion risk compared to existing devices
- Transcatheter delivery via femoral venous access
What is the PROTEA-PFO EFS study design?
| Parameter | Details |
|---|---|
| Study name | PROTEA-PFO Early Feasibility Study |
| ClinicalTrials.gov | NCT07172464 |
| FDA status | IDE approved |
| Enrollment target | Up to 15 patients |
| Number of sites | 5 US centers |
| First implant | December 2025 |
| Investigator | Dr. Carey Kimmelstiel (Tufts Medical Center) |
| Primary indication | Recurrent ischemic stroke prevention |
Why does PFO closure matter for stroke prevention?
PFO closure has become an established treatment for preventing recurrent stroke in patients with cryptogenic stroke and PFO. Clinical trials have demonstrated that PFO closure with existing devices significantly reduces stroke recurrence compared to medical therapy alone. The PROTEA-PFO aims to improve upon current devices with its novel sealing approach.
How does bioaccess® support structural heart EFS trials in Latin America?
While the PROTEA-PFO EFS is being conducted in the US, many structural heart companies initiate their first-in-human studies in Latin America before progressing to US Early Feasibility Studies. bioaccess® provides end-to-end support for structural heart device programs across the region.
**Developing a structural heart device?**
Consider Latin America for your FIH study before progressing to US EFS. bioaccess® has supported 50+ medtech companies. Contact bioaccess® today or explore our FIH-12™.
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