Embolization device gains FDA 510(k) clearance
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Boston Scientific announced it received FDA 510(k) clearance for its embolization device with a fibered detachable coil, indicated to obstruct or reduce blood flow in the peripheral vasculature.
The first procedure using the device was performed this week at the University of Alabama at Birmingham, according to a press release from the company.
The new embolization device (Embold) was designed for occlusion to stop hemorrhaging, prevent aneurysm ruptures, reduce the size of certain tumors and treat various venous abnormalities.
According to the release, the device features a nitinol delivery system that prevents kinks from forming during the procedure, reducing preparation and procedure times by limiting the amount of equipment and additional products required to complete treatment and may also reduce cost of the procedure.
“When performing an embolization procedure, it is essential to have a device that is easy to use from start to finish,” Theresa M. Caridi, MD, FSIR, director of the division of vascular and interventional radiology at the Heersink School of Medicine at the University of Alabama at Birmingham, and the first physician to treat a patient with the device, said in the release. “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.”
According to the release, a full commercial launch of the device will begin in the U.S. in the coming weeks.
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