Boston Scientific (NYSE:BSX) said its Direxion microcatheter notched regulatory wins in the U.S. and Europe for peripheral embolization.
Natick, Mass.-based Boston Scientific said the torqueable Direxion device, which landed 510(k) clearance from the FDA and CE Mark approval in the European Union, is used in procedures to embolize peripheral blood vessels in the treatment of conditions such as liver cancer or uterine fibroids.
"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," according to a press release.
"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. Riad Salem of Chicago’s 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," added Dr. Robert Lewandowski, also of Northwestern Memorial Hospital, who along with Salem was the 1st to use the Direxion device, according to the release.
"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," peripheral interventions president Jeff Mirviss said in prepared remarks. "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."