Boston Scientific's Guidezilla Guide Extension Catheter has secured 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark, which would enable the company to market the device in the US and European markets.
The Guidezilla device makes complex percutaneous coronary intervention (PCI) procedures easier by delivering interventional devices such as balloons and stents, especially in cases where additional backup support is required.
Boston Scientific Interventional Cardiology president Kevin Ballinger said that the company is committed to delivering innovative technologies such as the Guidezilla device that enable physicians to improve outcomes for patients undergoing complex coronary interventions.
"The Guidezilla guide extension catheter is a specialty device that provides physicians another compelling tool to help treat difficult lesions," Ballinger added.
Besides offering pushability and kink resistance, the stainless steel hypotube shaft’s hydrophilic coating on the outer-diameter reduces friction, which allows interventional cardiologists to navigate difficult to reach areas.
Guide extension catheters are used in coronary angioplasty and stenting procedures which open blocked arteries by atherosclerosis. Coronary artery disease is one of the leading causes of death in the US and if left untreated, the blocked arteries can cause angina and heart attack.