New data show zero device-related complications or atrial fibrillation, no recurrent stroke or TIA, with a cohort 40% larger than Gore and Amplatzer device studies
FOUNTAIN VALLEY, Calif., Sept. 16, 2025 /PRNewswire/ — NobleStitch™, the deviceless suture-mediated patent foramen ovale (PFO) closure system distributed worldwide by HeartStitch, Inc., today announces robust long-term clinical results from the largest cohort ever reported for PFO closure, underscoring its unparalleled safety and efficacy.
Published recently in JACC: Advances, the landmark study led by Prof. Achille Gaspardone, followed 703 patients over a median of 4 years, a patient population approximately 40% larger than the closure arms of the pivotal Gore and Amplatzer (REDUCE and RESPECT) trials. Remarkably, there were no recurrent strokes or transient ischemic attacks (TIA) across this extensive follow-up, coupled with zero device-related complications or device-related episodes of atrial fibrillation.
While other device-based closures have demonstrated notable rates of atrial fibrillation (5.7–6.6%) 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 demonstrates that while 11.7% of patients had significant residual right to left shunt, they still displayed no post-procedure strokes or TIAs. Importantly, this paper and comments from Dr. Bryan Kluck, reveals a paradigm-shifting insight: full anatomical 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.
Dr. Gaspardone commented,
“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. This may represent a safer, less invasive approach with durable protection from stroke.”
Renowned cardiology expert Dr. Bryan W. Kluck noted in an accompanying editorial that the absence of neurologic events despite residual shunting challenges conventional assumptions and supports the unique benefit of suture-mediated closure in avoiding device-related pro-thrombotic and hemodynamic alterations seen with traditional metal devices.
Dr. Anthony Nobles, CEO of Nobles Medical Technologies II, commented, This landmark study affirms NobleStitch™ as a best-in-class therapeutic option for PFO-associated stroke prevention, delivering both clinical efficacy and an exceptional safety profile. The minimally invasive, device-free system preserves atrial anatomy, facilitates future interventions if needed, and offers a compelling alternative to established device closure technologies.
For further information, visit www.noblesmed2.com and HeartStitch.com.
About NobleStitch™ and HeartStitch, Inc.
NobleStitch™ is a patented suture-mediated cardiovascular closure system offering a device-free alternative for structural heart defects. HeartStitch, Inc. is its exclusive global distributor, committed to advancing patient care through innovation.
NobleStitch is Manufactured and distributed by HeartStitch, Inc.
The NobleStitch EL is FDA cleared in the USA for cardiovascular suturing and CE Marked in the EU for cardiovascular suturing PFO closure.
The NobleStitch EL is covered by several US and international patents (visit www.noblesmed2.com)
Media Contact:
[email protected]
SOURCE HeartStitch® Inc.
