TEMBO Embolic System

The TEMBO Embolic System is a sterile, single-use gelatin-based embolization device consisting of biocompatible, dry resorbable porcine gelatin particles (85-225 µm) in a 10 mL syringe. It is intended for embolizing hypervascular tumors and occluding blood vessels in the peripheral vasculature by creating a mechanical barrier to blood flow when hydrated with contrast media and delivered via microcatheter.

TEMBO contains gelatin and sodium chloride particles with non-uniform shape and dry size of 85-255 µm, compared to the predicate EmboCube which contains only gelatin with uniform cube-shaped particles of 2.5 mm and 5 mm. The hydrated TEMBO particle size falls within the reference device Gel-Bead's size ranges. Both devices provide mechanical blood flow barriers delivered via microcatheters with similar clinical indications.

ISO 10993-1 (biocompatibility evaluation for implant blood-contact devices >30 days), ISO 11137-1 and 11137-2 (gamma radiation sterilization), ISO 22442-1 (animal tissue-derived medical devices risk management), and LAL bacterial endotoxin testing per validated methods.

TEMBO is substantially equivalent because it shares the same fundamental design principle (mechanical blood flow occlusion via gelatin particles), operating principle (hydration with contrast and microcatheter delivery), intended use (embolization of hypervascular tumors and peripheral vasculature), and core technology (biocompatible gelatin) as the predicate EmboCube. Although particle size and shape differ, these differences do not raise new safety or performance concerns, as demonstrated by comparative testing and animal studies showing equivalent embolic effects. The hydrated particle sizes align with the reference device, and comprehensive biocompatibility, sterility, and performance testing all met predetermined specifications with no adverse findings.