HeartStitch™ Expanding Products’ Clinical Databases Across The Globe
Dr. Niels Erik-Nielsen Quickly Accumulating Diverse Case Histories
With Ongoing Use Of HeartStitch’s NobleStitch™ EL
Los Angeles, California—June 16, 2016 —As one of Europe’s first interventional cardiologists to fully embrace the the benefits of HeartStitch’s NobleStitch™ EL device for PFO closure, Dr. Niels Erik-Nielsen has amassed significant experience with its use in a wide variety of situations. His breadth of experience has been instrumental in building a growing body of international clinical evidence documenting HeartStitch® devices’ advantages.
Due to the number of patients he has treated to date with the NobleStitch™ EL, and his enthusiasm for HeartStitch’s engineering approach, the company has named Dr. Erik-Nielsen and the University Heart Center in Linköping, Sweden as one of its next proctoring centers.
Professor Anthony Nobles, Chairman of the Board and HeartStitch® CEO, commented, “We are all very excited to have Dr. Niels Erik-Nielsen and the University Heart Center recognized as one of our official training centers in Europe. His extensive level of experience as a cardiologist in the structural heart field makes him a powerful evangelist for our products, and for the HeartStitch brand.”
Dirk Segers, Vice President, International Sales and Marketing for HeartStitch® further stated, “During such a crucial phase in HeartStitch’s European-market growth, we are fortunate to have such a widely-respected surgeon clearly impressed with our products. The consistent pace of his surgeries, the database he’s building, and his continuous demonstration of our powerful technologies will prove an important foundation for our growing success.”
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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.
HeartStitch® Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the structural heart marketplace. HeartStitch® is focused on innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures.
The HeartStitch® TA and HeartStitch® MR are FDA cleared for vascular suturing in the United States. 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 cardio-vascular suturing and PFO closure in the European Union and the Republic of Kazakhstan, respectively.
HeartStitch® is a registered trademark of HeartStitch, Inc .
HeartStitch® TA for cardiac suturing and transapical access and 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, 8348962, 8469975, 8496676, and 8709020.
HeartStitch® MR for suturing an anatomical valve
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 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 HeartStitch® visit www.HeartStitch.com