1593.2 – Bioinductive implant for the repair of rotator cuff tear

Referral from the Medical Devices and Human Tissue Advisory Committee

The bioinductive collagen implant (REGENETEN), when used in isolation (partial-thickness tears) or as an adjunct to a mechanical repair (full-thickness tears), provides a porous scaffold for the formation of new tendon-like tissue. It supports the body’s natural healing response to facilitate new tendon-like tissue growth.

Type: Therapeutic technology

A rotator cuff tear (RCT) is the partial or full detachment of the tendon that attaches the muscles from the shoulder blade to the head of the humerus. The cause of RCT is multifactorial and likely a combination of age-related chronic degeneration of the tendon, direct micro/macro trauma (acute), impingement and/or repetitive or vigorous overhead activity. 

The following consultation deadlines apply:

• Pre-PASC consultation deadline: Bypassing PASC
• Pre-MSAC consultation deadline: Friday 13 June 2025 11:59 pm AEST  

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This application will be considered at the following meetings:

• PASC meeting: Bypassing PASC
• ESC meeting: 12-13 June 2025
• MSAC meeting: 31 July - 1 August 2025

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The outcome of this application is pending.

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