Vascutek has announced the return to market of the Anaconda bifurcate body stent graft system for patients with abdominal aortic aneurysms. The system was voluntarily recalled in October 2013 following the identification of a potential issue with the release wire in the delivery system.
Vascutek has worked closely with its UK Competent Authority, Medicines and Healthcare products Regulatory Agency, and notified body, British Standards Institution to review the plans for return to market and, having satisfied the regulatory requirements, Anaconda can now be released for clinician use.
Vascutek president and chief executive officer, Paul Holbrook, says: “Our development work at Vascutek is all about the patient, putting the highest standards of patient safety and product quality at the forefront of all we do. We are pleased that this popular system can now return to use. We are working hard to get stock to where it is most urgently needed first, and we are in discussions with customers to manage this whilst stock levels begin to return to normal over the coming months. We have been overwhelmed with support from the medical community across the globe as we investigated this issue. We would like to thank everybody for their understanding and patience during this time.”
The Anaconda stent graft system is used to treat abdominal aortic aneurysms. More than 17,000 Anaconda stent grafts have been implanted since the system was launched in 2005.