HeartStitch’s NobleStitch Suture-Mediated PFO Closure System Evaluated in Large Cohort Study

September 29, 2025—HeartStitch, Inc. announced long-term clinical results from a study of a large cohort of patients evaluating the company’s NobleStitch deviceless suture-mediated patent foramen ovale (PFO) closure system. In the United States, the NobleStitch EL is FDA cleared for cardiovascular suturing. In Europe, the device has received CE Mark approval for cardiovascular suturing PFO closure.

The company advised that the data, which highlight the device’s safety and efficacy, were published by Professor Achille Gaspardone, MD, et al in JACC: Advances.

According to the company, the investigators followed 703 patients for a median of 4 years after PFO closure and found there were no recurrent strokes or transient ischemic attacks (TIA), with zero device-related complications or device-related episodes of atrial fibrillation. By contrast, other device-based closures have demonstrated notable rates of atrial fibrillation (from 5.7% to 6.6%) and device-related adverse events.

The NobleStitch system’s fully suture-mediated approach eliminates permanent metallic implants, drastically reducing procedural risks and long-term complications. The data demonstrate that 11.7% of patients had significant residual right to left shunt but they displayed no postprocedure strokes or TIAs, reported HeartStitch.

“Our findings suggest that reducing the dynamic right-to-left shunt by adjusting septal anatomy using sutures can effectively prevent embolic events without necessitating full closure,” commented Dr. Gaspardone in the company’s press release. “This may represent a safer, less invasive approach with durable protection from stroke.”

In an accompanying editorial, Bryan W. Kluck, DO, stated that the absence of neurologic events despite residual shunting challenges conventional assumptions and supports the benefit of suture-mediated closure in avoiding device-related prothrombotic and hemodynamic alterations seen with traditional metal devices, noted the company.

HeartStitch further stated that the study by Prof. Gaspardone et al and the commentary from Dr. Kluck reveal a paradigm-shifting insight: full anatomic closure of the PFO is not always required to prevent recurrent stroke. The protective mechanism appears to hinge on modifying the atrial septal anatomy and restoring physiological flow patterns, rather than complete elimination of residual shunting. This aligns with the finding that even patients with residual shunts after NobleStitch closure experienced no recurrent neurologic events over years of follow-up, concluded the company.