Instylla announced it has won FDA 510(k) clearance for its Tembo Embolic System. Bedford, Massachusetts-based Instylla said the Tembo system is a bioresorbable embolisation agent with particles designed for embolisation of hypervascular tumours and blood vessels to occlude blood flow in the peripheral vasculature. Those irregularly shaped, dry gelatin particles range in size between 85 and 255 micrometers.
“We plan to collaborate with leading experts in interventional radiology to maximize the clinical benefits of the Tembo Embolic System,” Instylla CEO Amar Sawhney said in a news release. “While our primary focus continues to be the completion of the PMA process for our flagship product, Embrace Hydrogel Embolic System, we pride ourselves on providing novel resorbable embolic agents to interventional radiologists specifically designed for new and existing embolotherapies.”
Sawhney is also managing director of Incept, which founded Instylla in 2017.
Dr. Venkatesh Krishnasamy, director of interventional oncology and interventional research and associate professor at the University of Alabama said the new system could address limitations associated with currently available permanent spherical embolics.
“This innovation in short-term absorbable embolics [is] characterized by its irregular shape, easy preparation and use, high visibility, and capacity to pack treated vessels densely. … The Tembo Embolic also has the potential to play a key therapeutic role in various other clinical applications and vascular territories,” Krishnasamy said in the news release.
