Nobles Medical Has Perfect FDA Audit
Nobles Medical today announced that it has received a NAI (No Actions Indicated) determination from its recent FDA audit; this is the second year in a row that the company has received this perfect result.
Fountain Valley, California (PRWEB) September 13, 2013
Prof. Dr. Anthony Nobles, CEO of NMT2 commented, “Our record in Regulatory Affairs and Quality Assurance is the backbone of our company. Being recognized by the FDA as well as our European notified bodies demonstrates our commitment to safety and efficacy in our products worldwide.”
Ben Brosch, President of NMT2 commented, “Since joining Dr. Nobles 21 years ago we have strived to always meet the highest standards and develop a strong relationship with the FDA. We recognize the financial benefits of a quality system and what it means to our companies long term future and value and will continue to make safety and quality one of our highest priorities”.
Gus Chompff, Vice President of Operations who was integral in the development of the companies systems that were inspected by the FDA commented, “Having worked with Dr. Nobles companies for more than 13 years we have always held the highest standards and the result of these recent audits reflect that record”
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
For the original version on PRWeb visit: http://www.prweb.com/releases/2013/9/prweb11120918.htm