
Guardian Medical USA announced that a significant milestone has been surpassed for its pre-validated sterile barrier packaging system, CapSure™.
Tracy Momany, President and CEO of Guardian Medical, said, “The company is right on target with its efforts to ensure our sterile barrier tube packaging system is meeting market demands for longer shelf life of terminally sterile medical devices. From the start, we set our eyes on designing and manufacturing a package that outperforms other types of packaging used for implants in orthopedic and spine surgery. Now, having met the 7-year accelerated aging testing parameters, we will be able to offer the testing protocols, methods and results to all our
customers and clients interested in labeling that supports 7-year expiration date claims.”
The seal and closure mechanism is what truly defines the performance a customer and, ultimately, a patient receives from the CapSure™ tube package, said Don Kennedy, VP Sales and Marketing.
“Adding the ability to extend the shelf life of a terminally sterile implant, equates to actual savings from that mechanism,” he said.
In late May, Guardian reported that it successfully raised more than $2 million in recent private financing. The company has made steady progress in gaining key customers in the spine, foot/ankle and trauma orthopedic market segments. The funding allowed Guardian to accelerate product development and facilities growth to meet upcoming demand and significant interest in using rigid tubes to sterile package orthopedic implants and devices of all types and sizes.