NobleStitch™ Suture-Mediated PFO Closure Demonstrates Superior Long-Term Safety and Outcomes in Largest Cohort to Date

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.