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Boston Scientific (NYSE:BSX) this week announced it received FDA 510(k) clearance for the Embold fibered detachable coil for use in the peripheral vasculature.

Marlborough, Massachusetts–based Boston Scientific designed Embold for use in a number of embolization procedures that block one or more blood vessels to obstruct or reduce blood flow. The procedure stops hemorrhaging, prevents aneurysm ruptures, reduces the size of certain tumors and treats venous abnormalities.

The company also announced the first procedure using the Embold fibered detachable coil following the FDA clearance. It was performed at the University of Alabama at Birmingham.

“When performing an embolization procedure, it is essential to have a device that is easy to use from start to finish,” said Dr. Theresa Caridi, director of the division of vascular and interventional radiology from the Heersink School of Medicine at the University of Alabama at Birmingham, who also performed the first procedure of the device. “The multi-catheter compatibility of the Embold fibered coil provides physicians the flexibility of catheter choice and helps reduce the number of potential device exchanges, which may improve procedure efficiency and enable better patient outcomes.”

Embold uses a nitinol delivery system that is designed to prevent kinks from forming in the device during use. Boston Scientific said the device could reduce preparation and procedure times by limiting the amount of equipment and additional products needed to complete treatment.

“The Embold fibered coil was developed to address physician feedback about the need to simplify the embolization process,” Peter Pattison, president of interventional cardiology in Boston Scientific’s peripheral interventions business, said in a news release. “With the introduction of this coil, physicians now have a tool that streamlines the embolization procedure, and we continue to explore innovative solutions that meet physician needs so they can provide the highest standard of care to their patients.”

Filed Under: 510(k), Cardiovascular, Catheters, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Boston Scientific

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