BioFiber Scaffold Post-Market Observational Study

BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study

The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.

Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.

Inclusion Criteria:

• Patients 18 years of age or older

  • Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair.
  • Patients willing and able to comply with the requirements of the study protocol and provide informed consent.

Exclusion Criteria:

• Patients with active or latent infection
• Patients with decreased vascularity
• Patients with pathological soft tissue conditions
• Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate
• Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)
• Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager