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June 28, 2023
Boston Scientific Receives FDA 510(k) Clearance for Embold Soft and Packing Coils
June 28, 2023—Boston Scientific Corporation announced it has received FDA 510(k) clearance for the Embold Soft and Packing coils, which are designed for use in a variety of embolization procedures.
The company explained in its press release that this approval strengthens the company’s embolic profile by creating a single platform with three coils: Embold Soft, Embold Packing, and Embold Fibered, which received FDA clearance last year and is available in the United States, Canada, and Japan.
The company noted that its three-coil platform allows physicians to more simply address a variety of patient needs and anatomies and also streamlines hospital inventory.
“The addition of the Soft and Packing coils now completes the Embold platform and is expected to build upon the success we’ve already seen with the launch of our Fibered coil last year,” commented Peter Pattison, President of Interventional Oncology & Embolization at Boston Scientific in the company press release. “With the full platform of Embold coils, along with our conformable embolic, Obsidio, we will be able to offer our customers a complementary and highly differentiated portfolio of embolics, enabling them to provide highly personalized care to address the unique needs of their patients.”
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