Boston Scientific’s Embold Fibered Detachable Coil Receives FDA Clearance

April 28, 2022—Boston Scientific Corporation announced it has received FDA 510(k) clearance for the Embold fibered detachable coil, which is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. A full commercial launch of the device will begin in the United States in the coming weeks.

An addition to Boston Scientific’s interventional oncology portfolio, the Embold fibered coil was designed for use in a variety of embolization procedures to stop hemorrhaging, prevent aneurysm ruptures, reduce the size of certain tumors, and treat a variety of venous abnormalities. The device features multicatheter compatibility and a nitinol delivery system that prevents kinks from forming in the device during the procedure, noted the company.

This week, the first procedure using the device was performed by Theresa M. Caridi, MD, at the University of Alabama at Birmingham (UAB) in Birmingham, Alabama. Dr. Caridi is Director, Division of Vascular and Interventional Radiology at the Heersink School of Medicine at UAB.

“When performing an embolization procedure, it is essential to have a device that is easy to use from start to finish,” commented Dr. Caridi in Boston Scientific’s press release. “The multicatheter 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.”