NobleStitch™ EL Sales Launch in Italy
First Italian NobleStitch™ EL Case Successfully Performed
Rome, Italy—Tuesday, April 19, 2016— Nobles Medical Technologies II, Inc. (NMT2) today announced that Prof. Cesare Greco, Associate Professor of Cardiology, Sapienza University of Rome consulting with Prof. Carlo Gaudio of the Policlinico Umberto 1, Rome, Italy successfully performed the first ever suture based percutaneous PFO closure in Italy using the NobleStitch™ EL. Reported in (http://m.ilmessaggero.it/primopiano/articolo-1640429.html). This marks the official sales release of the NobleStitch™ EL in Italy.
Dr. Michael Mullen, Cardiologist St. Bartholomew’s Hospital, London, member of the NMT2 clinical advisory board, was present to proctor the Italian team. Dr. Mullen commented, “We achieved successful closure in a 52-year-old female who had suffered a previous stroke and required PFO closure. This patient had a relatively short tunnel which, in the past, we believed was not suitable for this technology. However, with the improved technique we have developed through the many cases I have been involved in, we have become more precise and this allows us to close a broader subset of patients.”
Prof. Cesare Greco, Associate Professor of Cardiology, Sapienza University of Rome
commented, “This system is revolutionary. It allows secure PFO closure without implanting the Nitinol disc that would have been 2.5cm in the atria of the heart, to be left forever in the patient. This 45-minute procedure also avoided the need for the 2 antiplatelet drugs we would have had to use with the metal implants; this is an important advance.”
Prof. Anthony Nobles, CEO of NMT2 commented, “We continue to expand our technology to more physicians, more hospitals, in more countries. These successful cases provide us ongoing feedback to expand our indications, and improve our technique. Italy will be a significant market for NMT2 as we expand through the European Union.”
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 to cross over to the arterial side. The presence of a PFO has been linked to a number of clinical issues, mainly stokes, 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 Technologies II
Nobles Medical Technologies II, Inc. was founded with the intent of leveraging its technologies in the PFO and ASD-closure 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.
For more on Nobles Medical Technologies II visit www.NoblesMedicalTechnology.com.