Scottish vascular graft company Vascutek has announced the return to market of its Anaconda™ Bifurcate Body Stent Graft System. The system has been out of circulation since October 2013.
Vascutek’s Anaconda stent graft system is used to treat abdominal aortic aneurysms and more than 17,000 Anaconda stent grafts have been implanted since the system was launched in 2005.
Back in early 2012 we covered the news that the UK’s competent regulatory authority, the MHRA had issued a Field Safety Notice pertaining to the Anaconda device for the reason that in some circumstances an extra step was required to remove part of the bifurcate delivery device. Then in October 2013 the graft was withdrawn from the market following the identification of a potential issue with the release wire in the delivery system. It’s this problem that the company has presumably addressed in the intervening months.
Vascutek says it has worked closely with the MHRA, and notified body, British Standards Institution (BSi) 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 CEO, Paul Holbrook, said; “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.”
Source: Vascutek Ltd.