SOURCE: Nobles Medical Technologies II

Heartstitch, Inc.

July 22, 2016 09:04 ET

NobleStitch ASD Closure Case Highlights Septal Defect Closure Revolution at CSI Conference

Prof. Nobles Presented Revolutionary First in Man Clinical Case of ASD (Atrial Septal Defect) Closure and ASA (Atrial Septal Aneurysm) Repair at Structural Heart Conference

FRANKFURT, GERMANY--(Marketwired - July 22, 2016) - Nobles Medical Technologies II (NMT2) continued to surprise the more than 900 cardiologist and cardiac-specialist attendees at the CSI conference on structural heart interventions with its presentation of the first-ever ASA repair, ASD and PFO closure case. Prof. Anthony Nobles, CEO and Chief Clinical Specialist of NMT2, presented the case in detail, highlighting its unique series of "firsts": the first-ever closure of an ASD without surgery or without the use of a device implanted in the heart; the first-ever repair of an ASA (atrial septal aneurysm) performed percutaneously using only suture; and using a second NobleStitch device, the first-ever completion of three unique structural heart repairs in a single patient.

Dr. Niels Erik Nielsen, Director of structural heart interventions at Linköping University Hospital, Linköping, Sweden, performed the case with Prof. Nobles proctoring the new technique. Dr. Nielsen commented on the significance of the procedure, and its meaning for the overall treatment of septal defects in the future: "The NobleStitch allowed us to successfully address these three structural heart abnormalities with only a "simple" suture -- without implantation of an umbrella device, and without the inherent risks of having such a device, such as arrhythmia, embolization or late erosion."

Prof. Anthony Nobles, CEO, Chief Clinical Specialist of NMT2 and inventor of the NobleStitch™ EL, who assisted Dr. Nielsen during the case by providing technical support commented, "The success of this "First-In-Man" case with the NobleStitch demonstrates our technologies' ability to treat a broader range of structural heart defects. Presenting this at CSI, in front of the world's leading experts during the same week that Prof. Horst Sievert performed the successful Live PFO case and Dr. Mullen presented the multi-center data on NobleStitch™ EL for PFO closure, provided international demonstration that there is an alternative method for closing these defects without open-heart surgery, and without the need to leave large metal implants in the heart."

Ben Brosch, President of NMT2 commented, "This presentation represents NMT2 staking a claim in the septal defect marketplace, proving we can address ASD's, PFO's and ASA's. We have also seen a wiliness by our physicians to expand their use of the NobleStitch, which from a business perspective accelerates sales growth of the NobleStitch world-wide.

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.

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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