Heartstitch GmbH Announces Noblestitch EL Closure Data Compared To Published PFO Clinical Trials "RESPECT" And "CLOSURE" In The New England Journal of Medicine
Published: Oct 10, 2017
FRANKFURT, Germany, Oct. 6, 2017 /PRNewswire/ -- Prof. Dr. Achille Gaspardone, Director of Cardiology at Hospital of Sant'Eugenio (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).
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."
About PFO Closure
A PFO is a relatively common heart defect characterized by an unsealed tunnel between the right and left atria of the heart. This defect has been known to be present in anywhere between 27%-38% of people. However, in a number of cases, it is benign.
The PFO is formed as a trace of the fetal circulation. When the chambers of a human heart begin to develop, a tunnel is made between the right and left atria, allowing blood to flow directly from the venous circulation to the arterial circulation, circumventing the non-functioning fetal lungs. Following birth, the pressure differential between the right and left atria changes with newly operational blood flow to the fully functioning lungs. Because of this, the tunnel eventually closes completely within the first few months.
However, in some patients, the foramen ovale fails to seal and stays "patent." In patients with a Patent Foramen Ovale (PFO), the tunnel can reopen under elevated atrial pressure, such as coughing, or straining.
A key issue with PFO is that it gives a pathway for blood clots to pass directly to the arterial circulation without being filtered out by the capillary bed of the lungs. A PFO can also let deoxygenated blood and certain chemicals cross over to the arterial side. The presence of a PFO has been linked to a number of clinical issues, mainly strokes, migraines and chronic fatigue. Developments are being made to solidify the link between PFO and strokes or migraines, and to identify patients that would benefit from PFO closure.
HeartStitch® Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the structural heart marketplace. HeartStitch® is focused on innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures.
The HeartStitch® TA and HeartStitch® MR are FDA cleared for vascular suturing in the United States. HeartStitch® manufactures and markets the NobleStitch EL under exclusive license from Nobles Medical technologies II, Inc. NobleStitch EL is FDA cleared for vascular suturing in the United States and CE Marked for cardio-vascular suturing and PFO closure in the European Union and the Republic of Kazakhstan, respectively.
HeartStitch® is a registered trademark of HeartStitch® Inc.
HeartStitch® TA for cardiac suturing and transapical access and closure
Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8348962, 8469975, 8496676, and 8709020.
HeartStitch® MR for suturing an anatomical valve
Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8348962, 8469975, 8496676, 8709020, and 8771296.
NobleStitch EL for PFO closure
Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8197510, 8246636, 8348962, 8372089, 8469975, 8496676, 8709020, and 9131938.
For more on HeartStitch® visit http://www.heartstitch.com
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