Merit Medical announced today that it has received US Food and Drug Administration (FDA) breakthrough device designation for its Embosphere microspheres.
Utah-based Merit Medical’s breakthrough nod covers the Embosphere microspheres for the genicular artery embolization (GAE) indication for reducing blood flow to the knee to reduce pain and disability caused by knee osteoarthritis.
Merit Medical said in a news release that Embosphere microspheres are the most clinically utilised and clinically studied spherical embolic, having been used in more than 250,000 procedures.
“We are pleased with the recognition and partnership of the FDA, making it possible for new and innovative products to reach the market faster,” Merit Medical chairperson and chief executive officer Fred P. Lampropoulos said in the release. “Merit’s embolotherapy platform of products has provided consistent and predictable results for effective embolization. We believe this breakthrough designation allows us to accelerate our programmes to study and obtain FDA clearance for the GAE indication for Embosphere microspheres, ultimately expanding treatment options for patients.”
In October 2021, Varian received an FDA breakthrough device designation for microspheres under the same indication for GAE in treating knee osteoarthritis.