1593 – Bovine bioinductive collagen implant for repair of rotator cuff tear

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Not supported

Application details

Reason for application

New application.

Service or technology in this application

Insertion of a bioinductive collagen implant (REGENETEN), to induce formation of new tendon-like tissue that biologically augments the degenerated rotator cuff tendon. The physical and chemical properties of the scaffold provide a layer of collagen between a flat tendon and surrounding tissue, permitting collagen in-growth into the scaffold, and promoting collagen re-modelling with alignment of the collagen fibres in the direction of the stress in the tendon. The scaffold is hydrated in saline and positioned arthroscopically through a small incision over the tendon, with one end overlapping the tendon insertion. Tendon and bone staples are used to secure the scaffold in place, while the new tissue is being generated. The procedure may also be performed by mini-open surgery. The procedure is performed under general anaesthesia.

Type: Therapeutic medical service

Medical condition this application addresses

The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of the upper arm bone (humerus) firmly within the shallow socket of the shoulder. A rotator cuff tear is the partial or full detachment of the tendon (that attaches muscles from the shoulder blade to the head of the humerus). The cause of rotator cuff tear is multi-factorial, and likely to be a combination of age-related chronic degeneration of the tendon, direct micro/macro trauma (acute), impingement and/or repetitive or vigorous overhead activity. Rotator cuff tear is the most common cause of pain and disability related to the shoulder, but can also be asymptomatic. Prevalence of rotator cuff tear increases with age, with rotator cuff tears being present in approximately 25% of individuals in their 60s, and 50% of individuals in their 80s. The rotator cuff has limited ability for spontaneous healing, in the absence of repair.

Meetings to consider this application

  • PASC meeting: 8 August 2019
  • ESC meeting: 12 June 2020
  • MSAC meeting: 28 - 29 July 2020