Prof Horst Seivert Opens the 2016 CSI Structural Heart Congress by performing a live PFO closure case using Noblestitch EL
Prof Seivert successfully closes large PFO with a single suture in front of more than 500 top cardiologists from Europe.
Frankfurt, Germany—June 23, 2016 — At the opening of the CSI Structural Heart Conference attendees witnessed a 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 of Cardiac Specialists from around the world, who witnessed the successful closure of a PFO that 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 a PFO using only suture garnered a tremendous positive response both during the case and in the days following.
The case performed involved a 38 year-old female with a history of neurological deficiet. Dr. Horst Sievert (Director and Founder CVC Frankfurt, Germany; Board of Directors CSI) accompanied by Dr. Michael Mullen (Consultant Cardiologist, St. Bartholomew’s Heart Center London, and Chief Medical Officer of NMT II) with technical support from the device inventor Prof. Anthony Nobles (CEO and Chief Clinical Specialist of Nobles Medical Technologies II, Inc.™).
Prof Sievert commented, “At the beginning of the case when I saw how large the PFO was, even after having recently done several cases requiring only a single suture, I still thought it might be necessary to use two sutures in this very large defect. I also believed that we might still have a small residual shunt at the end of the case. I continued to be impressed after completing the case with only a single suture we found absolutely no residual shunt. This is an amazing technology.”
Dr. Mullen, who also presented multi-center clinical data on the NobleStich™ EL during the session on PFO closure, further commented, “We have continued to develop and improve the NobleStitch™ technology and procedure over the last several years. This case demonstrates the simplicity of the technology and more importantly the clinical result. As physicians it is important to understand that leaving only a single suture behind and no implanted device defines simplicity for PFO closure.”
Prof Nobles commented, “Firstly I think it is important to recognize that we provided a very young patient a technology that avoided the potential complications that a device implant cause over time and to give this patient the piece of mind that her PFO is fully closed she hasn’t had to receive additional anti-coagulation and will not have to worry about a device remaining in her heart for the next several decades. It was also a big honor for our company to be one of the first 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. Furthermore, having Prof. Horst Sievert and Dr. Mike Mullen perform the case live allowed the audience the opportunity to interact in real time asking questions that provided a deeper understanding of our technology.
Dirk Segers International Vice President of sales Marketing for Heartstitch® Inc. (who markets the NobleStich™ EL worldwide), was in attendance in the audience during the live case, and commented, “In my many years of experience launching new innovative technologies, I have never before seen such a immediate positive response that continued throughout the duration of the Congress. We experienced our largest physician attendance for our hands on training sessions to date. We also received several invitations to leading Structural Heart Centers in Countries worldwide.”
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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