Capitan Orthopedics has received breakthrough device designation from the US Food and Drug Administration (FDA) for its SupraSpacer implant, which provides a new treatment potential for patients with irreparable rotator cuff tears.
More than two million individuals a year are currently diagnosed with rotator cuff injuries, and over 700,000 patients undergo surgery to repair a primary tear.
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Patients with injuries that cannot be repaired using traditional soft tissue procedures often have limited options to regain motion or alleviate pain.
For most people aged under 60 years, reverse shoulder replacement does not serve as an effective solution.
According to Capitan Orthopedics, the SupraSpacer implant is intended to restore joint alignment in the shoulder where damaged tendons can no longer support the joint.
The device functions by providing support within the joint, preventing the humerus from shifting upwards and restoring the joint to its natural position.
It also aims to preserve the ability for patients to explore further surgical options if required in the future.
Capitan Orthopedics CEO Chance Leonard said: “I am excited to announce that Capitan Orthopedics has received breakthrough device designation for its SupraSpacer implant technology. This is yet another milestone achievement for our team, and this designation validates the significant unmet medical need.
“Today is a special day. We continue to be encouraged by the strength of the unmet clinical need we are addressing and the progress we have made in delivering a solution that is both innovative and practical. With core development complete and a clear regulatory path ahead, we believe this is a compelling moment to accelerate forward.”
Capitan Orthopedics developed the SupraSpacer implant and procedure to target younger patients.
The system is designed for use in ambulatory surgery centres and is supplied with sterile instruments and implants to facilitate procedural efficiency.
