Relay Plus Thoracic Stent Graft receives Japanese PMDA approval

PMDA approval
PMDA approval

On 1 April 2013 Bolton Medical announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) had approved the Relay Thoracic Stent Graft with Plus Delivery System. 

Relay, according to the company, is designed to conform in the tortuous anatomy of the thoracic aorta, while reducing the potential for stent graft migration and endoleaks after the placement. Additionally, Relay has a wide range of sizes, both in straight and tapered configurations, to adapt to various anatomies.

Bolton Medical stated that the Plus delivery system has a unique dual structure consisting of inner and outer sheaths. The hydrophilic coating on the outer sheath allows for smooth manipulation in the vessel. The soft flexible inner sheath reduces the potential for trauma to vasculature and facilitates navigation while allowing accurate placement.

Bolton Medical stent grafts have been used in Europe and other international markets since 2005 and, to date, according to the company, more than 8,500 Relay and Relay NBS Thoracic Stent-Grafts have been implanted worldwide.

“It has been a very exciting time at Bolton Medical in the past months as we have achieved major milestones such as the US Food and Drug Administration (FDA) and the Japanese PMDA approvals for the Relay Thoracic Stent-Graft, and the CE mark approval for the Treovance Abdominal Stent Graft. We are confident that these milestones pursue our vision about becoming a major global player providing the best aortic repair solutions to the endovascularcommunity,said Guillermo Portabella, CEO, Bolton Medical.

The Relay Thoracic Stent-Graft with Plus Delivery System is expected to be distributed in Japan by Japan Lifeline.