FRANKFURT, Germany, July 9, 2018 /PRNewswire/ — Prof. Dr. Achille Gaspardone, Director of Cardiology at Hospital of Sant’ Eugenio (Rome, Italy), and Prof. Dr. Horst Sievert MD, Director and Founder of Cardio Vascular Center (Frankfurt Germany), presented a LIVE PFO Closure to attendees of the Transcatheter Valve Therapies (TVT) Congress in Chicago, IL. The case was transmitted via satellite LIVE from the CVC Center in Frankfurt, Germany. This was the first opportunity for a US audience to be presented a real-time PFO closure using the NobleStitch™ EL.
TVT 2018 is a 3-day symposium gathering physicians worldwide to participate in clinical workshops, panel sessions, innovation sessions and Live Case presentations to exchange the latest in data, research, techniques and treatments for transcatheter aortic and mitral valve therapies. The recent developments in PFO closure have attracted industry wide interest with TVT highlighting an entire program around PFO. Prof. Dr. Achille Gaspardone, the principal investigator and author of the recent publication of Italian study data in the current issue of EuroIntervention, highlights the success of the NSEL for closure. (https://www.prnewswire.com/news-releases/noblestitch-el-italian-registry-data-published-in-eurointervention-300626377.html).
Prof. Dr. Gaspardone provided his experience as published and his expanded data showing reduced flouro time and contrast used, which he plans to publish at TCT this fall. Prof. Dr. Gaspardone commented during the LIVE case, “This technology is a revolution, the first new technology in PFO closure in 20 years, it’s my first choice to treat a PFO because it’s safer and leaves nothing in the left heart, I have done more than 200 cases and this is the system I would use for my family members and therefore for any of my patients that are a candidate.”
Professor Anthony Nobles, Inventor of the NobleStitch™ EL and Chairman, CEO and Chief Clinical Officer of HeartStitch®, Inc. stated, “We were pleased that Prof. Sievert and Prof. Gaspardone collaborated on this case and chose to present the clinical benefits of the NobleStitch™ at the TVT/ PFO congress. These are two physicians who collectively have more than 300 cases performed.”
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 communication 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 communication eventually closes completely within the first few months.
However, in some patients, the foramen ovale fails to seal and remains “patent.” In patients with a Patent Foramen Ovale (PFO), the communication 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.
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 cardiovascular-suturing marketplace. The company does business under the name of Nobles Medical II (NMT II). Initial efforts of the company have been focused in Europe 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 and Cardiovascular suturing in the United States. Further information including warnings and precautions can be found in the instructions for use.
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
About HeartStitch®
HeartStitch® Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the structural heart marketplace. HeartStitch® is focused on the innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures. HeartStitch® currently markets under license the NobleStitch™ EL device for cardiovascular suturing and PFO closure. HeartStitch™ develops new structural heart technologies through its international innovation development teams in California, Kazakhstan and Germany.
The HeartStitch® Access Pro (formally HeartStitch® TA) and the HeartStitch® Coap Pro (formally the HeartStitch® MR) are FDA cleared for vascular suturing in the United States.
HeartStitch® is a registered trademark of HeartStitch, Inc.
HeartStitch® Access Pro
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® Coap Pro
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
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 www.HeartStitch.com
|
For more information, please contact: |
|
|
USA |
In Kazakhstan |
|
Dru Dobbs |
Kazbek Aubakirov |
|
P. +1 714 427 6348 |
P. +7 777 5009005 |
|
F. +1 714 427 6343 |
|
|
Nazarbayev University |
|
|
Jannet Turarbekova |
|
|
National Cardiac Research Center |
|
|
Asel Mazhibayeva |
|
SOURCE Nobles Medical Technology II, Inc.
