Bioretec Activa Implants Reach 100,000-Patient Milestone
Bioretec's bioabsorbable Activa implants, designed for fracture repair, arthrodesis, etc., reached the milestone of 100,000 patients operated over 10 years, with a complication rate of 0.01%.
The Activa line comprises pins, nails, screws, etc. for use in upper and lower extremities, and is used in 33 countries. Its poly L-lactide-co-glycolide copolymer base material maintains strength and elasticity for at least eight weeks and offers controlled bioabsorption within approximately two years, resulting in no need for a surgery to remove the device.
The company received its first FDA 510(k) in 2006, for the Activa Pin. In 2010, Bioretec received CE Mark approval for CiproScrew, an antibiotic-releasing bioabsorbable screw.
Sources: Bioretec Ltd.; bioretec.com; ORTHOWORLD Inc.