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FDA Clearance, CE Mark Approval

Manufacturing Group | November 26, 2013

Direxion Torqueable Microcatheter Gets Approvals; Proprietary Shaft Design Enables Better Control in Hard-to-Navigate Vessels

FDA Clearance, CE Mark Approval

Further bolstering its market-leading portfolio of peripheral embolization technologies, Boston Scientific Corp. has received U.S. Food and Drug Administration clearance and CE Mark approval for its Direxion Torqueable Microcatheter.

Peripheral embolization is a technique used primarily by interventional radiologists to treat liver cancer, uterine fibroids and other challenging conditions.  It involves deliberately blocking a blood vessel to prevent blood flow to an area of the body, which can effectively shrink a tumor or block an aneurysm.

"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," says Riad Salem, M.D., MBA, professor of Radiology and director of Interventional Oncology at Northwestern Memorial Hospital. 

"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, M.D., associate professor of Radiology at Northwestern Memorial Hospital.

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

The Direxion Torqueable Microcatheter 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. This technology is designed to maximize 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 Direxion Torqueable 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.  

"Boston Scientific is committed to supporting interventional radiologists with innovative technologies designed to improve outcomes for patients suffering from challenging conditions such as liver cancer and uterine fibroids," states Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. "The Direxion Torqueable Microcatheter adds a completely new technology to our market-leading peripheral embolization portfolio, and its unique slotted nitinol hypotube technology will provide physicians with unrivaled handling characteristics."

Source: Boston Scientific Corp.

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