Advice

Summary

Summary

The ATEC breast biopsy system is a vacuum‑assisted breast biopsy device. It can be used under ultrasound, stereotactic and MRI guidance. The evidence shows that the ATEC system works successfully with all 3 imaging modalities, with a trade‑off between faster procedure times and sample quality, and the incidence of complications. The list price of the ATEC Sapphire console is £15,000 excluding VAT. The list price of the disposable components needed for each biopsy procedure varies between £239 and £459, depending on the type of image guidance used.

Product summary and likely place in therapy

  • The ATEC system is a vacuum‑assisted breast biopsy (VABB) device intended to collect breast tissue samples for diagnostic sampling of breast abnormalities.

  • The ATEC system would be used in place of standard biopsy techniques including core needle biopsy and open (surgical) biopsy.

Effectiveness and safety

  • Seven studies were identified that reported outcomes for VABB with the ATEC system. One used ultrasound guidance, 4 used stereotactic guidance and 2 used MRI guidance.

  • In comparison with the Mammotome VABB system, 1 prospective study showed that the ATEC system had faster biopsy times, but decreased sample quality. A retrospective study showed the ATEC system was about 30 minutes faster than the Bard Vacora VABB system for a single biopsy site and 20 minutes faster for 2 biopsy sites.

  • Total excision was achieved in 64.7% of lesions for the ATEC 9 gauge and 60.0% of lesions for the ATEC 12 gauge, compared with 85.7% of lesions using the Mammotome 8 gauge and 88.9% of lesions with the Mammotome 11 gauge.

  • One prospective study showed that biopsies using the ATEC 12‑gauge needle had statistically significantly more incidences of bleeding than those using the Mammotome 11‑gauge needle. The same study showed that post‑interventional haematomas were seen statistically significantly more often with the ATEC 12 gauge than with the Mammotome 11 gauge. Another retrospective study showed that pain was noted statistically significantly less frequently with the ATEC system than with the Vacora system.

  • One retrospective study showed no statistically significant difference between the ATEC 9 gauge and Mammotome 11 gauge for the frequency of atypical ductal hyperplasia, tumour upgrade rate or the mean number of biopsy samples taken. Another prospective study showed that the diagnoses made with ATEC‑acquired samples agreed with surgical histology results.

Technical and patient factors

  • The ATEC system consists of a console and a handpiece to collect the samples. It is available with different sized needles.

  • The system can deliver anaesthetic directly into the biopsy site during the procedure through a Y‑valve at the rear of the handpiece. Saline lavage of the biopsy site can also be done using the system.

  • Tissue collection is controlled by the operator using a footswitch. Samples can be taken at a maximum rate of 1 every 4.5 seconds.

  • The ATEC system can be used under ultrasound or stereotactic guidance in an outpatient setting or can be used under 1.5T and 3T MRI guidance in a radiology department.

Cost and resource use

  • The list price of the ATEC Sapphire console is £15,000.

  • The per procedure list prices of accessories needed for imaging modalities are £239 for ultrasound, £245.50 for stereotactic and £459 for MRI. Depending on the stereotactic device used, a reusable adapter may also be needed at an additional list price of £3500.

  • These prices do not include imaging costs or VAT.