Devices & Diagnostics

Boston Scientific gets FDA clearance and CE Mark for embolization catheter

Boston Scientific (BSX) received FDA clearance and the CE Mark for its Direxion Torqueable Microcatheter. The catheter is the company’s newest addition to its peripheral embolization medical device technology portfolio. Radiologists use peripheral embolization to treat liver cancer and uterine fibroids, among other conditions. “It involves deliberately blocking a blood vessel to prevent blood flow to […]

Boston Scientific (BSX) received FDA clearance and the CE Mark for its Direxion Torqueable Microcatheter. The catheter is the company’s newest addition to its peripheral embolization medical device technology portfolio. Radiologists use peripheral embolization to treat liver cancer and uterine fibroids, among other 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,” according to a company statement.

The specs according to a company statement:

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.

A “slotted nitinol hypotube” is credited with allowing for easier handling.

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