Tornier has enrolled and treated first patient with Simpliciti stemless shoulder joint replacement system in its investigational device exemption (IDE) study.
The study is a prospective, multi-center, FDA-approved clinical trial for a stemless shoulder prosthesis.
The first patient in the Simpliciti IDE study was treated by Thomas Thomas, an orthopaedic surgeon specialized in shoulder surgery at Saint Agnes Hospital in Fresno.
The shoulder system bridges the gap between humeral bone resurfacing and traditional shoulder arthroplasty systems and provides bone-preserving benefits and necessary surgical access.
The trial is designed to enroll 157 patients who will be followed for two years.
Saint Agnes Hospital orthopaedic surgeon Thomas Thomas said Simpliciti is an alternative for patients needing a shoulder replacement that preserves humeral bone, simplifies the surgical approach and renders potential future interventions much less complicated.
Tornier plans to launch Simpliciti system outside of the US.