The FDA cleared Lyon, France-based Medicrea's PASS XS posterior fixation and LigaPASS XS band connector components.
Here are five key notes:
1. These two cleared components are designed for pediatric spinal deformities in small-stature patients.
2. Medicrea collaborated with pediatric spine surgeons to create implants for pediatric deformity surgery.
3. Surgeons may use the extra-small PASS and LigaPASS components to treat pediatric patients with about 40 percent less implant volume in each surgery.
4. These extra-small components feature the lowest construct profile in-situ in the market.
5. Medicrea expects to report the first surgery with the PASS XS and LigaPASS XS components in the United States in November.