Crossroads Neurovascular has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its “groundbreaking” PATH BGC device—a next-generation balloon guide catheter (BGC) designed to advance neurovascular intervention.
A Crossroads press release claims that, with this clearance, PATH BGC becomes the “world’s first” BGC engineered specifically for neurovascular use that is fully compatible with a 7Fr system, offering greater procedural flexibility, and enabling access in smaller and more distal arteries where “traditional BGCs cannot reach”.
PATH BGC has been purpose-built for complex anatomies and was developed with input from leading neurointerventionists, according to Crossroads. The device is designed to address the challenges of navigating tortuous anatomy and accessing distal targets during interventional stroke treatments as well as other neurovascular procedures.
Key features of PATH BGC include its 7Fr sheath compatibility, extended tip design (2cm), optimisation for tortuous anatomy, and enhanced kink resistance and stability. The latter characteristic is intended to provide benefits specifically in challenging aortic arch anatomies.
“The PATH BGC establishes a new standard in neurovascular intervention by enabling safe and precise access to distal anatomy,” Crossroads’ recent release notes. “Its advanced design enhances physician control during procedures, supporting more effective treatment and improved outcomes for patients with ischaemic stroke and other complex cerebrovascular conditions.”
