Fountain Valley, California (PRWEB) May 16, 2014
Elvia has more than 23 years experience in Regulatory Affairs and Quality Assurance. She has extensive experience in US and international design controls and procedures. She has drafted and worked on PMA’s and 510K’s as well as CE mark for several products working for St. Jude Medical, Cannon Medical Systems and several med device companies during her career.
Prof. Dr. Anthony Nobles, CEO of NMT2 commented, “Elvia has all the skills and training we were looking for to fill this position. Her most impressive skill is her desire to maintain safety and efficacy throughout our companies development and manufacturing assuring our products meet the highest standards. She exemplifies our long standing tradition that RA/ QA is one of the most critical parts of our business and we make no exceptions for safety.”
Ben Brosch, President of NMT2 commented, “Elvia has the talent and expertise to take us into the next phase of our business as we grow worldwide, she was an integral part of our recent successful audit with the FDA and we expect great things from her as we bring our suturing solutions to the world for PFO closure and Septal repair”.
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