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FDA Designates Osteoarthritis Microspheres a Breakthrough Device

October 18, 2021

Palo Alto, Calif.-based Varian has received the FDA’s breakthrough device designation for its Embozene microspheres for treatment of symptomatic knee osteoarthritis.

The microspheres are delivered in a minimally invasive procedure to reduce blood flow to the periarticular tissue of the joints, limiting the inflammatory process.

The microspheres have other applications, such as blocking blood flow to hypervascular tumors, arteriovenous malformations and uterine fibroids.

Varian, a Siemens Healthineers subsidiary, has also received 510(k) clearance from the FDA for the Embozene microspheres.

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