Bedford, MA-based liquid embolics developer Instylla has received clearance from the U.S. Food and Drug Administration (FDA) for its Tembo embolic system.
Tembo is a bioresorbable embolization agent made of irregularly shaped, dry gelatin particles in a size range of 85 to 255 microns. The particles are designed for the embolization of hypervascular tumors and blood vessels to stop blood flow in the peripheral vasculature, the company said.
The short-term absorbable agent may be used in interventional radiology procedures such as uterine artery embolization, prostatic artery embolization, hypervascular tumor embolization, genicular artery embolization, and the management of endoleaks, Instylla noted.