Summary

Summary

The OnControl is a powered bone biopsy system which is intended to be used in place of a standard biopsy needle. It is designed to enable faster access and improved biopsy samples, and to be less painful than manual aspiration techniques. A systematic review of 5 randomised controlled trials showed a statistically significant reduction in pain and increase in biopsy length compared with manual techniques. The OnControl system costs £61.30 per procedure compared with £86 for a manual needle.

Product summary and likely place in therapy

  • The OnControl powered bone biopsy system consists of a battery powered drill which, together with appropriately sized needles, is designed to allow bone marrow aspiration and biopsy.

  • The OnControl system would be used in place of current manual needle aspiration and biopsy techniques.

  • The OnControl system is intended for use in secondary care settings by qualified healthcare professionals who are familiar with bone marrow aspiration and biopsy procedures and are specifically trained to use the system.

Effectiveness and safety

  • 1 systematic review (n=282) included data from 5 randomised controlled trials (n=26, 50, 50, 54 and 102) that met the inclusion criteria.

  • The systematic review reported a statistically significant reduction in pain experienced by people who had a biopsy using the OnControl system. The mean biopsy length when using the OnControl system was 14.5 mm, a statistically significant increase of 3.6 mm compared with manual biopsy.

  • Adverse events were higher with the OnControl system at 2.5%, compared with 0% for manual biopsy (p=0.17); none was serious and all resolved.

Technical factors

  • The OnControl system is the only powered bone marrow biopsy system currently available. The powered driver uses a non‑replaceable, non‑rechargeable battery providing approximately 200 uses.

Cost and resource use

  • Each OnControl system costs £260; assuming 200 uses, this is equivalent to £1.30 per procedure. A biopsy needle for single use with the OnControl system costs £60 and can be used for a biopsy and aspiration procedures compared with a typical cost of £86 for a manual biopsy needle.

  • The OnControl system may be able to gather more usable material than manual procedures, so there may be further benefits from avoiding repeat procedures.