On the 12 July, Boston Scientific announced it had received US Food and Drug Administration (FDA) 510(k) clearance and CE mark approval for the Guidezilla guide extension catheter and has launched the device in the USA and Europe.
The Guidezilla device, according to the company, is designed to make complex percutaneous coronary intervention (PCI) procedures easier by more efficiently delivering interventional devices, including balloons and stents, in situations where extra backup support is needed.
“The Guidezilla device provides a new level of confidence and reassurance in treating complex lesions,” said John Lasala, director, Cardiac Catheterization Lab, Barnes-Jewish Hospital and director of Interventional Cardiology at Washington University, St Louis, USA. “I have found it can reduce the time and effort required in many complex procedures.”
According to the company, the stainless steel hypotube shaft provides pushability and kink resistance, and the hydrophilic coating on the outer diameter reduces friction.