MARLBOROUGH, Mass., April 28, 2022 – Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (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. The first procedure using the device was performed this week at the University of Alabama at Birmingham.
The newest addition to the Boston Scientific interventional oncology portfolio, the EMBOLD Fibered Coil was designed for use in a variety of embolization procedures, a minimally invasive treatment intended to block one or more blood vessels to obstruct or reduce blood flow. Occlusion in this manner is a technique used to stop hemorrhaging, prevent aneurysm ruptures, reduce the size of certain tumors and treat a variety of venous abnormalities.
“When performing an embolization procedure, it is essential to have a device that is easy to use from start to finish,” said Dr. Theresa M. Caridi, director, Division of Vascular and Interventional Radiology from the Heersink School of Medicine at the University of Alabama at Birmingham, and the first physician to treat a patient with the EMBOLD Fibered Detachable Coil.[i] “The multi-catheter compatibility 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.”
In addition to the multi-catheter compatibility of the EMBOLD Fibered Coil, the device also features a nitinol delivery system that prevents kinks from forming in the device during the procedure – features intended to reduce treatment complications. These design attributes may also reduce preparation and procedure times by limiting the amount of equipment and additional products required to complete treatment, which may reduce the overall cost of the procedure.
“The EMBOLD Fibered Coil was developed to address physician feedback about the need to simplify the embolization process,” said Peter Pattison, president, Interventional Oncology, Peripheral Interventions, Boston Scientific. “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.”
A full commercial launch of the device will begin in the U.S. in the coming weeks. For more information, please visit the EMBOLD™ Fibered Detachable Coil page on the Boston Scientific website.
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[i] Dr. Theresa M. Caridi has not been compensated by Boston Scientific Corporation for her quote within this news release.