HeartStitch® GmbH Announces NobleStitch™ EL Closure Data Compared to Published PFO Clinical Trials “RESPECT” and “CLOSURE” in New England Journal of Medicine

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Dr. Achille Gaspardone Presented The Italian/Swedish Data Registry For HeartStitch®’s PFO Suture Based Closure System

[junkie-alert style=”grey”] Prof. Dr. Achille Gaspardone, Director of Cardiology at Hospital of Sant’Eugenio in Rome, Italy presented a comprehensive report on closure of PFO (Patent Foramen Ovale) utilizing the NobleStitch™ EL suture based closure system at the CSI-UCSF meeting on Congenital Structural Interventions in San Francisco. The NobleStitch™ EL, which is manufactured and marketed by HeartStitch® Inc., has been used extensively throughout Italy with Dr. Gaspardone in Rome performing the largest series of cases (more than 75 cases). [/junkie-alert]

The data was collected from 10 centers throughout Italy and one center in Sweden from January 2016 through August 2017, and was gathered from more than 190 patients, from procedures performed by 14 interventional cardiologists.  These patients were undergoing PFO closure for Stroke, Transient Ischemic Attack, Pulmonary Embolism, Decompression Illness and migraine with positive MR+.  All patients were successfully treated with the NobleStitch™ EL closure system.

Dr. Gaspardone compared the NobleStitch™ EL data for closure rate, and adverse events (complications) using the same criteria listed in the recently published RESPECT and CLOSURE clinical studies that were just published in the most recent New England Journal of Medicine.  The NobleStitch™ EL demonstrated a superior closure rate to both the Gore Helix® and AGA Amplatzer™ for closure with a zero residual shunt rate at 12 months follow-up.  Additionally, the NobleStitch™ EL had no complications compared to the 4.2% complication rate found in the RESPECT trial and a 12.8% complication rate found in the CLOSURE trial.

Dr. Gaspardone also presented a comparison to the previous PFO closure studies CLOSURE 1 and PC Trial and demonstrated a superior closure rate than found in the CLOSURE 1 study and equivalent closure rate to the PC Trial and more importantly the NobleStitch™ EL which had no complications compared to the CLOSURE 1 16.9% complication rate and the PC Trial 21% complication rate.

Dr. Gaspardone stated, “This initial registry included all patients treated and included the learning curve cases at each center.  Unlike the afore mentioned studies using the umbrella based devices which were performed primarily by physicians with extensive experience implanting the umbrellas over many years, The NobleStitch™ EL Registry Data was collected with many users performing their very first cases.  The NobleStitch™ EL is a simple safe and effective way to close the septal defects without leaving behind a large metal prosthesis in the heart and without the risk of known complications of the umbrella implants which include, atrial fibrillation, migration, erosion, left ventricular thrombosis and nickel allergy.”  Dr. Gaspardone further stated, “Although we have experience with more than 300 cases with this technology, we still continue to improve our techniques and outcomes with each new case, and I expect to see even greater increase in the positive data presented so far.  Personally, if it were my family member or myself, as it is with all my patients, the NobleStitch™ EL suture would always be my first choice to close PFO.”

Professor Anthony Nobles, Chairman, CEO and Chief Clinical Specialist of HeartStitch®, commented: ” HeartStitch® is focused on surgical suture solutions to structural heart defects including PFO and ASD. This study is the first clinical series of its kind for a HeartStitch® technology to be presented head to head with published competitive data. Having Dr. Gaspardone, who is known for his exceptional scientific clinical analysis and clinical technical skills, provide this multicenter data that demonstrates that the NobleStitch™ EL can provide a safe and effective closure that has equal to better closure rates and less complications than the traditional umbrella devices is a major milestone for HeartStitch®. We continue to expand the HeartStitch® customer base for the NobleStitch™ EL throughout Europe and Central Asia, which is critical for HeartStitch®‘s upcoming product line focused on solutions for Mitral valves, Tricuspid valves and Trans-apical access and closure technologies.”