Merit’s Embosphere Microspheres Receive FDA Breakthrough Device Designation for Genicular Artery Embolization to Treat Knee Osteoarthritis

March 7, 2022—Merit Medical Systems, Inc. announced that it has received Breakthrough Device designation from the FDA for a genicular artery embolization (GAE) indication for the company’s Embosphere microspheres. GAE is intended to reduce pain and disability caused by knee osteoarthritis by reducing blood flow to the knee, thereby minimizing the inflammatory process.

The company noted that the FDA Breakthrough Device program is intended to provide patients and health care providers with more timely access to breakthrough technologies that have the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA has undertaken to provide priority review and interactive communication regarding device development and clinical trial protocols through commercialization decisions.

Fred P. Lampropoulos, Merit Medical’s Chairman and Chief Executive Officer, commented in the company’s press release, “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.”