Boston Scientific obtains FDA and CE Mark approvals for new microcatheter

20 November 2013 (Last Updated November 20th, 2013 18:30)

Boston Scientific has obtained US Food and Drug Administration (FDA) clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to embolise peripheral blood vessels in the treatment of conditions such as liver cancer or uterine fibroids.

Direxion

Boston Scientific has obtained US Food and Drug Administration (FDA) clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to embolise peripheral blood vessels in the treatment of conditions such as liver cancer or uterine fibroids.

Direxion torqueable microcatheter is designed to facilitate selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature.

It will make it easier for interventional radiologists using peripheral embolisation to treat liver cancer, uterine fibroids and other challenging conditions.

To accomplish this, a blood vessel is blocked to prevent blood flow to an area of the body, which can effectively shrink a tumour or block an anaeurysm.

The microcatheter is reportedly the newest addition to the company's peripheral embolisation medical device technology portfolio.

Available in a 0.021in or 0.027in inner diameter the device is made using slotted, nitinol hypotube technology that promises excellent control in order to reach the most challenging anatomy.

There are six different tips to choose from and it is available with guidewire tips in pre-loaded configurations common to embolisation procedures.

These configurations include the physician's choice of the Fathom-16 guidewire, Transend-14 guidewire, or Transend-18 guidewire.

"The Direxion microcatheter's handling characteristics are intended to enable physicians to efficiently access difficult to navigate vessels across many types of peripheral embolisation procedures."

Northwestern Memorial Hospital professor of radiology Dr Riad Salem 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 embolisation procedures."

Northwestern Memorial Hospital associate professor of radiology Dr Robert Lewandowski added: "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."

Drs Salem and Lewandowski were the first users of this platform worldwide, the company reported.

Boston Scientific Peripheral Interventions president Jeff Mirviss said the company is supporting interventional radiologists with technologies designed to improve outcomes for patients suffering from challenging conditions such as liver cancer and uterine fibroids.

"The Direxion torqueable microcatheter adds a completely new technology to our market-leading peripheral embolisation portfolio, and its unique slotted nitinol hypotube technology will provide physicians with unrivaled handling characteristics," Mirviss said.


Image: Direxion torqueable microcatheter receives FDA clearance and CE Mark approval. Photo: courtesy of Boston Scientific Corporation.