Boston Scientific granted EU and US approval for Direxion microcatheter

Boston Scientific has been granted regulatory approval for its new Direxion Torqueable Microcatheter in the US and Europe.

US Food and Drug Administration clearance and CE Mark approval has been granted to the device, which is optimised for use in peripheral embolisation therapy for challenging conditions such as liver cancer and uterine fibroids.

It has been designed to facilitate selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature, maximising torque transmission in the catheter shaft to enable better control in hard-to-navigate vessels.

The product is available in six tip variations, as well as pre-loaded configurations, designed to suit a range of peripheral embolisation procedures.

Jeff Mirviss, president of peripheral interventions at Boston Scientific, said: "The Direxion Torqueable Microcatheter adds a completely new technology to our market-leading peripheral embolisation portfolio and its unique slotted nitinol hypotube technology will provide physicians with unrivaled handling characteristics."

This comes after the company was granted European regulatory approval for the use of its Vercise deep brain stimulation system in the treatment of dystonia earlier this month.