Boston Scientific's Direxion Torqueable Microcatheter Receives FDA Clearance and CE Mark Approval

November 19, 2013—Boston Scientific Corporation (Natick, MA) announced that it has received US Food and Drug Administration clearance and European CE Mark approval for its Direxion torqueable microcatheter, part of its portfolio of peripheral embolization technologies used primarily by interventional radiologists to treat liver cancer, uterine fibroids, and other challenging conditions. 

According to Boston Scientific, the Direxion device is designed to facilitate selective access and delivery of diagnostic, embolic, and therapeutic materials into the peripheral vasculature. The device is offered in either a 0.021- or 0.027-inch inner diameter microcatheter that features a slotted, nitinol hypotube technology. It is designed to maximize torque transmission in the catheter shaft, which physicians need in order to reach the most challenging anatomy. 

The Direxion torqueable microcatheter is available in six tip configurations, as well as preloaded 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 first users of this platform were Riad Salem, MD, Professor of Radiology and Director of Interventional Oncology, and Robert Lewandowski, MD, Associate Professor of Radiology—both from Northwestern Memorial Hospital in Chicago, Illinois.

Dr. Salem stated, “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.” Dr. Lewandowski added, “Combined with a range of tip shape offerings and selection of preloaded systems, the Direxion microcatheter offers an attractive portfolio that opens up a whole new dimension in microcatheter technology.”