US and EU Nods for Boston Scientific’s Direxion™ Torqueable Microcatheter

Boston Scientific Corporation says U.S. FDA clearance and CE Mark approval for its Direxion™ Torqueable Microcatheter further bolsters its market-leading portfolio of peripheral embolization technologies.

Background

Peripheral embolization is employed 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.

Boston Scientific’s 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 claimed best-in-class handling demanded by physicians 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.

Physician comments

Riad Salem, M.D., MBA, professor of Radiology and director of Interventional Oncology at Northwestern Memorial Hospital, one of the first users of the platform said; “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.”

Another early user, Robert Lewandowski, M.D., associate professor of Radiology at Northwestern Memorial Hospital said; “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

Company comments

“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,” said 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., PR Newswire

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