Nobles Medical Technologies II, Inc. Receives Recertification of ISO13485 and EN-ISO 14971
Nobles Medical Technologies II, Inc. (NMT2) today announced that it has received recertification of its ISO13485 and EN-ISO 14971 after a successful audit by its European notified body. This successful audit recertifies NMT2 to manufacture and sell its PFO Closure and suture products throughout the European Union.
Fountain Valley, California (PRWEB) April 25, 2014
Prof. Dr. Anthony Nobles, CEO of NMT2 commented, “Our record in Regulatory Affairs and Quality Assurance worldwide shows our commitment to safety and efficacy, these successful audits and certifications demonstrate our internal standards which continue to be at the highest level.”
Ben Brosch, President of NMT2 commented, “Europe is currently our largest market and these certifications make it possible for us to continue to supply our NobleStitch products to the doctors, hospitals and patients that need these treatments and we are very proud of the level of quality and safety that they represent.”
Elvia Contreras-Lopez, Director of Regulatory Affairs and Quality Assurance, who was instrumental in the Audit commented, "We strive to meet the highest standards and maintain the systems that produce a safe and reliable product for our customers. Dr. Nobles companies have always met the highest standards in Regulatory and Quality and I am personally proud to be part of that long tradition with the great result of this audit and recertification.”
About Patent Foramen Ovale (PFO)
A PFO is a tunnel that exists between the left and right atrium of the heart. The tunnel, which is part of the normal fetal anatomy, should close shortly after birth. In 27% of the population the tunnel never closes. This tunnel can then allow clots and other chemicals to pass from the right to the left side of the heart freely bypassing the filter of the lungs. These clots and chemicals can cause strokes and other conditions such as severe migraines.
About the NobleStitch EL System
Nobles Medical Technologies II's NobleStitch EL is a catheter based system that allows a physician to place a suture in the PFO tunnel in the heart through a percutaneous puncture in the leg, in many cases under a local anesthetic in a catheter lab rather than an operating room. This eliminates the need for open-heart surgery or placement of a large metallic implant in the heart. The NobleStitch is not a “device” or mechanical implant it only places a simple polypropylene suture in the heart. By closing the hole or PFO, the therapy will reduce or eliminate the shunting from the right to the left side of the heart allowing the lungs to filter the clots and other chemicals from making it to the brain, potentially halting strokes and severe migraines and enabling patients to live a higher-quality life.
About Nobles Medical Technologies II
Nobles Medical Technologies II is a global structural heart company devoted to improving life through the development of its products and technologies. Nobles Medical Technologies II is focused on suture based solutions for the septum. The NobleStitch is available in Europe and is undergoing and IRB study for specific indication in the US. The NobleStitch has CE mark for “Cardiovascular suturing and PFO closure” and US FDA 510k clearance for “vascular suturing”.
Visit Nobles Medical Technologies II http://www.noblesmedicaltechnology.com
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