FDA/CE Nod And Launch For Boston Sci’s Guidezilla™ Guide Extension Catheter

Boston Scientific Corporation has received U.S. FDA 510(k) clearance and CE Mark approval for the Guidezilla™ Guide Extension Catheter and has launched the device in the U.S. and Europe. The company says its Guidezilla device 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.

Background

Guide extension catheters are used in coronary angioplasty and stenting procedures which open arteries blocked by atherosclerosis.

Boston Scientific says the stainless steel hypotube shaft incorporated in Guidezilla device provides pushability and kink resistance, and the hydrophilic coating on the outer-diameter reduces friction, making it easier for interventional cardiologists to navigate difficult to reach areas.

Physician comments

“The Guidezilla device provides a new level of confidence and reassurance in treating complex lesions,” said John Lasala, M.D., director, Cardiac Catheterization Lab, Barnes-Jewish Hospital and director of Interventional Cardiology at Washington University, St. Louis, Mo. “I’ve found it can reduce the time and effort required in many complex procedures.”

Company comments

“Boston Scientific is committed to delivering innovative technologies such as the Guidezilla device that enable physicians to improve outcomes for patients undergoing complex coronary interventions,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “The Guidezilla guide extension catheter is a specialty device that provides physicians another compelling tool to help treat difficult lesions.”

Source: Boston Scientific, Inc., PR Newswire