NobleStitch™ EL FEATURED AT ITALY'S GISE STRUCTURAL HEART CONGRESS IN GENOVA
Prof Giulio Speciale and Prof Achille Gaspardone Present the First Ever Italian Live Case of the NobleStitch™ EL Performed at the 2016 GISE Structural Heart Congress in Genova, Italy
Rome, Italy—October 18, 2016 — In Rome, Italy a satellite transmission of PFO closure using only a single stitch, rather than a large metal implant, was performed live to an audience of more than 600 top cardiologists from around the world at the GISE Structural Heart Conference on Thursday. The attendees witnessed the Live Case of percutaneous suture based closure of a PFO using the NobleStitch™ EL. The case was transmitted live to the main auditorium of the Congress from San Filippo Hospital in Rome. Dr. Gaspardone and his team successfully closed the PFO which was greater than a centimeter in diameter using only a single suture. This real time exposure to the ease of use and the clinical success without the use of a prosthetic implant (umbrella) to close the PFO using only suture garnered a tremendous positive response from the audience and the moderators who included renowned Italian Cardiologist Dr. Antonio Colombo who stated during the live broadcast that “this technique will definitely have a future” and Dr. Roxanne Mehran from the United States who commented during the live broadcast that “this is an incredible procedure and is unbelievable, I believe it has a huge future not leaving an implant”.
The case performed involved a 33 year old female with a history of neurological deficient. Prof. Dr. Giulio Speciale (Director of the Hemodynamic Operative Complex Unit Cardiovascular Department, Ospedale San Filippo Neri, Rome – Italy) and Prof. Dr. Achille Gaspadone (Director Division of Cardiology, Director Department of Medicine, Ospedale S.Eugenio – ASL RMC, Rome - Italy) accompanied by Prof. Anthony Nobles (CEO and Chief Clinical Specialist of Nobles Medical Technologies II, Inc.™) presented the details of the case and the technical aspects of the procedure during the live broadcast. The PFO which was approximately 1.5cm in length and more than 1cm in diameter was successfully closed without the need for post procedural anticoagulation. The final result was acute closure with no residual shunt.
Prof Gaspardone commented following the procedure, “We successfully performed the live PFO case using the NobleStitch™ EL at the recent 37th International Annual Meeting of the Italian Society Of Invasive Cardiology (GISE) and the audience was really impressed and astonished regarding the possibility to suture cardiac structures from outside. All the feedback was enthusiastic and the live case raised much interest on the new technique. After more than 20 years we have now a revolutionary technique that will completely change the approach to the treatment of PFO. The possibility to close PFO with a suture instead of a metallic device has many obvious advantages. The most important is that there no need to leave a cumbersome metallic prosthesis within the heart; it means no risk of embolization, myocardial damage, endocarditis, allergy and need of pharmacological treatment with potential side effects. If follow up data will confirm our preliminary results NobleStitch™ will very soon become the first option for the treatment of PFO. Lastly, I am convinced that this technology can be applied for other structural and valvular heart diseases.”
Prof. Speciale commented, “We are very happy to use the NobleStitch™ device in our cath lab in San Filippo Neri Hospital ASL ROMA 1. This procedure is unique because closes the PFO without leaving any metal device in the heart and without surgery. The first procedure performed in our hospital was broadcasted live to the meeting of the Italian society of interventional cardiology (GISE) which was held in Genoa, with the participation of the most important international interventional cardiologists. There is a lot of interest for this new technique in Italy and I am sure in the next few months many hospitals will start using the new NobleStitch™ device.”
Prof. Nobles commented, “Italy has quickly become our largest market and we recognized that the GISE conference was a critical venue to present a live case to show the simplicity of the NobleStitch™ EL. We were thrilled to have both Prof. Speciale and Prof. Gaspardone as part of this historic live case. Prof. Gaspardone has quickly become one of our most skilled users of the NobleStitch™, having performed more that 25 procedures in the last 3 months. It was also a big honor for our company to be selected as one of the first revolutionary technology cases performed at this years’ Congress and to be able to show this strong positive result to so many structural heart specialists at one time."
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.
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About Nobles Medical Technology II
Nobles Medical Technology II, Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the PFO, ASD-closure, and vascular-suturing marketplace. The company does business under the name of Nobles Medical II
(NMT II). Initial efforts of the company are focused on the innovative suture-based PFO closure system for closing the Patent Foramen Ovale (PFO), a tunnel between the right and left atria of the heart.
The NobleStitch™ is approved for PFO Closure and Cardiovascular suturing in the European Union. The NobleStitch™ EL is FDA cleared for vascular suturing in the United States. NobleStitch™ EL is distributed worldwide by HeartStitch®, Inc. (HeartStitch® is a registered trademark of HeartStitch, Inc.).
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.
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