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Devices Interventional Cardiology

 News Release - May 22, 2018

Nobles Medical Technologies II Showcases Noblestitch(TM) PFO Closure At EuroPCR

NOBLES MEDICAL TECHNOLOGIES II, INC. (NMT2) ANNOUNCES THE PRESENTATION OF ITS ITALIAN CLINICAL DATA PUBLISHED IN EUROINTERVENTION TO BE PRESENTED BY DR. FREDERICO DEMARCO

PARIS, May 22, 2018 -- (Healthcare Sales & Marketing Network) -- NMT2 announces it will be featured at the 2018 EUROPCR Congress in Paris, France. The annual assembly, which again takes place at the Palace de Congress in Paris from May 22-25, 2018, is the worldwide gathering for in-depth scientific presentations, new innovations, training and reports of clinical data results in the field of Structural Heart. Attendance of over 12,000 industry professionals provides a forum to present the NobleStitch™ EL technology to a broad base of physicians from around the world.

Dr. Federico De Marco, Interventional Cardiologist IRCCS Policlinico San Donato Hospital, will present the groundbreaking results from the Italian Multi Center Registry study published recently in EuroPCR's journal EuroIntervention (https://www.prnewswire.com/news-releases/noblestitch-el-italian-registry-data-published-in-eurointervention-300626377.html). Dr. De Marco will address the conference on Thursday, May 24 at 16:30 in Room 253 on Level 2. Dr. De Marco will highlight the successful results which demonstrated equivalent efficacy and a dramatically superior safety profile using the Noblestitch™ EL for PFO closure. The Noblestitch™ EL completed the 200 patient trial without a single device related complication. Statistics using occulder closure devices experienced device and/or procedural complications in a range of 4.6% – 16.9%. Of particular note was the predominant complication of atrial fibrillation, which is known to increase the risk of stroke and require in many cases a lifetime of anti-platelet therapy. Since the first Noblestitch™ EL case was performed 11 years ago, there has not been a single recorded case of atrial fibrillation.

Dr. Prof Achille Gaspardone, Director of Cardiology at Hospital of Sant'Eugenio (Rome, Italy), and the chief investigator of the Italian registry, commented, "From the first moment that I saw this technology, I recognized that it could possibly forever change our treatment of patent foramen ovale. Immediately after performing my first few cases using the device, it confirmed for me that the NobleStitch™ EL would become my first choice for closing PFO's. The device is simplistic in its approach, but revolutionary in its design. After participating in this clinical study and subsequently performing more than 150 cases to date, I am absolutely convinced that this is the future of PFO closure."

Professor Anthony Nobles, CEO and Inventor of the NobleStitch™ EL, noted, "It is always an exciting opportunity for us to host an Exhibit Booth at EuroPCR. Having a physical presence on the Exhibit floor gives us the ability to speak directly with physcians and distributors. It is important for us to be directly involved and provide support to our distributors. In my many years of attending congresses throughtout the world, I have found that industry professionals attend EuroPCR with an aim to seek out the newest technologies and advances in treatment. NMT2 is a company founded on the ideals of providing doctors with the tools to treat their patients in the safest, and least invasive means possible. I look forward to meeting the many physicians one on one who have expressed an interest in adding the NobleStitch™ EL System to their treatments."

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.

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 cardiovascular suturing and PFO closure in the European Union and the Republic of Kazakhstan, respectively.

For more on Nobles Medical Technologies II visit

http://www.noblesmed2.com

info@noblesmed2.com


Source: Nobles Medical Technology II

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