HOUSTON, TEXAS (May 22, 2018) – Procyrion, Inc., a clinical-stage medical device company developing the first catheter-deployed, intra-aortic pump for ambulatory use, Aortix, announced today the company received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a requirement for regulatory purposes and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
ISO 13485:2016 is an internationally recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
“The implementation of ISO 13485:2016 is the best internationally recognized model to help demonstrate that Procyrion has successfully complied to the laws and regulations of the medical devices industry,” said Katherine Cox, Senior Director, Quality Assurance for Procyrion. “This certification represents an important milestone for our company and reflects the focus we have on risk-based decision making throughout our organization with a commitment to safety and providing a high-quality product.”
Procyrion’s technology, Aortix™, which is thinner than a #2 pencil, is the first catheter-based heart pump designed specifically for the ambulatory treatment of NYHA Class III-IVa heart failure patients who are too sick for medication alone, but not sick enough for risky surgical interventions like heart transplants or LVAD implants. The small but powerful micro pump is placed downstream of the heart in a simple cath-lab procedure and works to support heart function by accelerating native blood flow, providing benefit upstream and downstream.
“This certification is further evidence of our unwavering commitment to quality and enables Procyrion to continue to develop Aortix in compliance with the highest standards for safety, product performance and reliability,” said Ben Hertzog, CEO for Procyrion. “Maintaining a world-class quality management system is a key goal for Procyrion.”
Houston-based medical device firm Procyrion, Inc. is developing the first catheter-deployed, intra-aortic pump for ambulatory use. The device is designed to rest and heal the heart by reducing afterload while simultaneously improving blood flow to vital organs. This groundbreaking interventional cardiology tool is expected to provide a minimally invasive treatment option for millions of chronic heart failure patients. For more information, visit www.procyrion.com or call 713.579.9227.