Direxion Torqueable Microcatheter gets FDA nod and CE mark approval

Direxion Torqueable Microcatheter
Direxion Torqueable Microcatheter

Boston Scientific has announced receiving US Food and Drug Administration (FDA) clearance and CE mark approval for the Direxion Torqueable Microcatheter, which is designed to suit a range of peripheral embolization procedures. 

Direxion is designed to facilitate selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature. The product, offered in either a 0.021” or 0.027” inner diameter microcatheter, features a slotted, nitinol hypotube technology.

A press release from Boston Scientific states that this technology is designed to maximise torque transmission in the catheter shaft, giving the Direxion Torqueable Microcatheter the best-in-class handling physicians need in order to reach the most challenging anatomy. The microcatheter is available in six tip configurations as well as pre-loaded configurations designed to suit a range of peripheral embolization procedures. These configurations include the physician’s choice of the Fathom-16 guidewire, Transend-14 guidewire, or Transend-18 guidewire.

“The Direxion Microcatheter’s unique handling characteristics are intended to enable physicians to efficiently access difficult to navigate vessels across many types of peripheral embolization procedures,” said Riad Salem, professor of Radiology and director of Interventional Oncology at Northwestern Memorial Hospital, Chicago, USA.

“Combined with a range of tip shape offerings and selection of pre-loaded systems, the Direxion Microcatheter offers an attractive portfolio that opens up a whole new dimension in microcatheter technology,” said Robert Lewandowski, associate professor of Radiology, who is also at Northwestern Memorial Hospital.

Salem and Lewandowski were the first users of this platform worldwide.