SALT LAKE CITY - July 25, 2005 - MasterControl Inc. today announced that SynCardia Systems Inc., manufacturer of the first FDA-approved temporary total artificial heart, has chosen the MasterControl™ quality management software solution to ensure regulatory compliance as the company enters the critical phase of making its breakthrough medical device available for commercial use.
The SynCardia CardioWest? temporary Total Artificial Heart (TAH-t) was approved by the FDA in October 2004 for use in patients at imminent risk of dying while they await a heart transplant. About 4,000 patients in the United States await heart transplants every year, according to the FDA.
"We've done research and development for a long time. Now, we're getting ready to become a commercial company. We have the team, the physical plant, and the technology all in place. It is with tremendous confidence that we chose MasterControl to be a significant component of the platform that will launch our product," said Rodger Ford, chief operating officer of SynCardia.
SynCardia, based in Tucson , Ariz. , currently supports six domestic and international medical centers that perform heart transplants. Its goal is to serve the majority of 200 such medical facilities worldwide. Over four hundred patients throughout the world have benefited from the company's pneumatically driven bi-ventricular device, which is implanted into the chest to replace the bottom half of the patient's heart. The device completely replaces the patient's native ventricles, leading to normalized blood pressure and restoration of the kidney and liver functions. The Syncardia temporary Total Artificial Heart was developed based on the technology and design of the Jarvik-7 total artificial heart, which made history in 1982 as the first artificial heart to be implanted.
SynCardia is required to comply with stringent FDA requirements, such as 21 CFR Part 11 for Electronic Records, and the Good Manufacturing Practices (GMP) outlined in 21 CFR Part 820. The company also adheres to ISO 13485, the internationally recognized medical device quality standard.
"We thoroughly evaluated many different software solutions to enhance our compliance program. We found that MasterControl provides the capacity to maintain full compliance with our regulatory requirements, and to improve our efficiency in terms of resources and time," said Carole Marcot, vice president of quality and regulatory affairs of SynCardia. ?It is also clear that MasterControl values our success and will be a strong partner in assuring the achievement of our commercial and regulatory goals.?
SynCardia plans to use MasterControl, which is 100 percent Web-based, throughout its operations. It plans to i mplement the following in September:
"SynCardia's mission to help save the lives of critically ill heart patients is inspiring," said Jon Beckstrand, CEO of MasterControl . ?We are proud to be SynCardia's partner and pleased to share our domain expertise and regulatory experience in its effort to reach out to more patients.?
MasterControl Inc., based in Salt Lake City , has been at the forefront of providing innovative electronic quality management systems since 1993. MasterControl provides a configurable, easy-to-use, and integrated system to help companies effectively manage and automate change control, training control, audits, corrective/preventive action (CAPA), and other quality processes under a single Web-based platform. MasterControl also offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. More than 400 companies worldwide use MasterControl to consistently meet FDA regulatory requirements and industry quality standards, including ISO and QS/TS.
For more information, visit www.mastercontrol.com , or call 800-825-9117.