Early Results Published From the NobleStitch EL Italian Registry of PFO Closure
April 9, 2018—Nobles Medical Technologies II, Inc. (NMT2) has announced the early publication of data for the company's NobleStitch EL for patent foramen ovale (PFO) closure. The NobleStitch EL is manufactured and marketed by HeartStitch under exclusive license from NMT2. The results from the NobleStitch EL Italian registry by Achille Gaspardone, MD, et al are available online in EuroIntervention.
According to NMT2, the prospective registry assessed the safety and efficacy of the "deviceless" technique using the NobleStitch EL suture-based PFO closure system. The registry included procedures performed between June 2016 and October 2017 at 12 sites in Italy. All patients were undergoing PFO closure for stroke, transient ischemic attack, pulmonary embolism, decompression illness, and migraine with positive magnetic resonance.
Of 200 consecutively evaluated patients, 192 were considered suitable for suture-mediated PFO closure (44 ± 13 years; 114 women). Suture of the septum with the NobleStitch system was carried out successfully in 186 (96%) patients. At 206 ± 130 days of follow-up, microbubbles transthoracic echocardiography with Valsalva maneuver revealed no right-to-left shunt (RLS; grade 0) in 139 (75%) patients and RLS grade ≤ 1 in 166 (89%) patients. There were no device-related complications.
Dr. Gaspardone, the Chief Investigator of the registry, concluded that "The early results of this first Italian registry indicates that the suture-mediated deviceless closure of PFO is feasible in the majority of septal anatomies, provides an effective closure of PFO comparable to traditional devices with an excellent safety profile at medium-term follow-up." Dr. Gaspardone is Director of Cardiology at Hospital of Sant'Eugenio in Rome, Italy.