Koru Medical Systems Given FDA’s 510(k) Clearance for New Use of Infusion System

Chester, N.Y.-based Koru Medical Systems has received FDA’s 510(k) clearance for use of its FreedomEdge infusion system to deliver pegcetacoplan 20 milliliter solution.

The drug, which is branded as Empaveli or Aspaveli and marketed by Apellis in the U.S. and by Sobi outside the U.S., is approved for treatment of adults with paroxysmal nocturnal hemoglobinuria, a life-threatening blood disorder

The disease is caused by an acquired mutation, which leads the patient’s immune system to destroy red blood cells, creating a need for frequent transfusions and symptoms, such as severe fatigue and difficulty breathing.

Koru specializes in subcutaneous self-administration of high-volume drugs (10 milliliters or more) in the home.