ROME , Nov. 19, 2024 /PRNewswire/ -- A comprehensive study led by Professor Dr. Achille Gaspardone was presented at the 2024 TCT Congress which, demonstrated the exceptional efficacy of the NoblestitchTM suture-mediated Patent Foramen Ovale (PFO) closure system in preventing recurrent strokes among patients with PFO associated stroke.
Involving 703 patients treated between 2016 and 2023, the study reported no recurrent strokes or transient ischemic attacks (TIAs) over an average follow-up of four years, underscoring NoblestitchTM as a highly effective solution for minimally invasive PFO closure. Key Findings Efficacy Outcome: Zero recurrent strokes or TIAs were observed across all 703 patients during the four-year follow-up period. Safety Profile: NoblestitchTM exhibited a robust safety profile with no suture-related complications.
Outcomes vs. Technical success: NoblestitchTM exhibited an 88% technical success at 12 month follow up. The sutured PFO configuration resulted in no strokes or TIA's independent of technical closure rates.
Dr. Gaspardone stated: "Suture mediated PFO closure is a long-term safe and effective procedure. The clinical outcomes of the suture mediated closure in our series are superior to the reported conventional umbrella closure device studies 1,2 for reduction of recurrent stroke and for reduction of device related complications including atrial fibrillation".
Dr. Anthony Nobles President of Nobles Medical Technologies II commented: "This landmark stu.