Merit Medical Systems has received the US Food & Drug Administration (FDA) breakthrough device designation for its Embosphere Microspheres for use in a type of intra-arterial intervention.
Its Embosphere Microspheres are indicated for Genicular Artery Embolization (GAE), a procedure intended to reduce pain and disability caused by knee osteoarthritis.
GAE procedure facilitates the embolotherapy by reducing the blood flow to knee, thereby minimising the inflammatory process.
Embosphere Microspheres are biocompatible and non-resorbable with cell adhesion properties that offer complete and durable mechanical occlusion.
Its hydrophilic surface and spherical shape would prevent aggregation in the catheter lumen and vasculature, and elastic properties facilitate smooth microcatheter passage.
According to the disposable medical devices company, Embosphere Microspheres are the most clinically used, and clinically studied spherical embolic solution.
The company said that Embosphere Microspheres were used in more than 250,000 procedures and included in more than 200 clinical articles.
Merit Medical chairman and CEO Fred P Lampropoulos said: “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’s embolotherapy platform of products has provided consistent and predictable results for effective embolization.
“We believe this breakthrough designation allows us to accelerate our programs to study and obtain FDA clearance for the GAE indication for Embosphere Microspheres, ultimately expanding treatment options for patients.”
Established in 1987, Merit Medical is engaged in development, production, and distribution of unique disposable medical devices used in different medical applications.
It offers disposable medical products for interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy.
It has facilities in the US, the UK, the Netherlands, France, Ireland, China, Mexico, Brazil, Canada, Australia, Japan, South Africa, and Singapore.
