SOURCE: Nobles Medical Technologies II, Inc.

Nobles Medical Technologies II, Inc.

September 11, 2015 06:00 ET

Nobles Medical Technologies II's NobleStitch EL Now the Primary Choice for PFO Closure at Top Swedish Heart Centre After Successful Annual Follow-Up on Initial Clinical Results

LOS ANGELES, CA--(Marketwired - Sep 11, 2015) -  Dr. Niels Erik Nielsen, Director of Structural Heart Interventions at the Linkoping University Hospital in Linkoping Sweden, has presented his data to Nobles Medical Technologies II reporting 100% success in patients since the first NobleStitch EL Patent Foramen Ovale (PFO) closure procedure was performed in May of 2014. 

Dr. N.E. Nielsen commented, "Our first patient was a 52 year old woman with previous stroke. The intervention was successful with immediate closure of the PFO, and the six and twelve month follow-up with TOE and TTE has shown a persistent, good result. Most recently, our experience was with four patients, three women ages 43, 47 and 49 years as well as one 55-year-old man. All of them had experienced a previous stroke or TIA. The immediate result was good in all patients and three have been on a six month follow-up, which shows consistent, positive results."

Dr. Nielsen further commented, "NobleStitch is a very attractive method of closing PFO because you leave only a suture, thereby avoiding the inherent risks implanting other devices (e.g. arrhythmia, embolization and/or late erosion), and furthermore it does not hinder access to the left atrium if needed in the future for other structural heart procedures. In our clinic, NobleStitch is now the primary choice for closing PFO after stroke/TIA and also in patients with severe migraine." 

Dr. Nielsen discovered the new treatment after attending a lecture given by Professor Anthony Nobles on PFO closure at the 2013 CSI structural heart meeting in Frankfurt, Germany. Dr. Nielsen then attended the Nobles Medical Technologies II training hub at the Congress for hands-on training using the NobleStitch EL

Professor Nobles, CEO of Nobles Medial Technologies II commented, "Working with Dr. Nielsen and his staff on our NobleStitch technology has allowed Dr. Nielsen to open treatment for PFO to his younger patients that may not otherwise be a candidate for the metal implants that potentially have significant side effects. Having NobleStitch as the primary choice of treatment for their patients over competitive device-based metal implants shows the short and mid term benefits of our technology." 

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 10%-25% 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.

About Nobles Medical Technologies II
Nobles Medical Technologies II, Inc. founded by Prof. Anthony Nobles 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.)

For more on Nobles Medical Technologies II visit www.NoblesMedicalTechnology.com.

About Prof. Anthony A. Nobles:
Professor Anthony (Tony) Nobles is considered one of the great minds in the medical device field. He is world-renown inventor, professor, lecturer, author, mentor, entrepreneur, CEO of various companies and biomedical engineer. On the personal side, Tony is also a Formula One racecar driver, Warbird pilot, philanthropist and most importantly, a devoted husband and father of six. www.AnthonyNoblesEnterprises.com

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