This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.
Hologic was awarded a Class IIa CE mark for the ATEC breast biopsy system in January 2009. The CE mark covers the console (ATEC Sapphire) and disposable handpiece. Other components needed for the ATEC system, such as the dedicated ATEC canister, adapter, remote tissue filter adapter, tissue adapter and needle guide, are Class I components.
The automated tissue excision and collection (ATEC) system is a vacuum‑assisted breast biopsy device. The system can be coupled with ultrasound, stereotactic or MRI techniques to help locate the suspicious lesion during breast biopsy.
The ATEC system consists of the ATEC Sapphire console unit, a disposable handpiece, which already contains a needle, and a tissue filter. The handpiece weighs 204 g, and is 4.2 cm in diameter and 26.8 cm long (excluding the needle). Needles are available in combinations of sizes (9 or 12 gauge, 9, 12 or 14 cm lengths and 12 or 20 mm apertures). Tissue collection is controlled by the operator through a footswitch. The time interval between each sample collection is dictated by the operator, however the ATEC system has a maximum sampling rate of 1 sample every 4.5 seconds. The vacuum, generated by the ATEC Sapphire console, draws the tissue into the ATEC tissue filter at the rear of the needle for collection. The tissue filter is then removed and the tissue can be transferred to a tube or container in preparation for histological assessment. Body fluids such as blood, and saline used during the biopsy, are collected in the canister. The operator rotates the needle within the lesion to ensure that biopsy cores are taken from all parts of the lesion.
Once tissue collection is complete, the biopsy site can be washed with saline using the handpiece. This is claimed to reduce the risk and size of haematoma (a collection of blood). Anaesthetic can also be delivered locally into the biopsy site either automatically or manually through a Y‑valve at the back of the device to control pain without interrupting the biopsy procedure. Anaesthetic is delivered in a radial pattern with each biopsy cycle, ensuring the local area is anesthetised. After the biopsy procedure, a radiopaque biopsy marker can be introduced and positioned using the handpiece needle by a side deployment delivery system.
The same handpiece can be used for both stereotactic‑ and ultrasound‑guided procedures. For stereotactic‑guided procedures, a specific needle guide and adapter are also needed depending on the stereotactic imaging system used. An MRI‑guided procedure needs a dedicated handpiece and an introducer localisation set. Also, because all the handpieces are completely disposable there is no need for cleaning after use. The ATEC Sapphire console can also be used with Hologic Eviva handpieces.
The ATEC breast biopsy system is intended to be used to collect breast tissue samples for diagnostic sampling of breast abnormalities. The healthcare setting in which it is used depends on the imaging technique (MRI, ultrasound or stereotactic). Both stereotactic‑ and ultrasound‑image‑guided biopsies can be done in an outpatient setting by a radiologist or advanced practitioner. MRI‑guided biopsies will be done in a radiology department by a radiologist or advanced practitioner. Biopsies done under the 3 imaging modalities are all minimally invasive.
Methods for breast biopsy include open, image‑guided core biopsy and vacuum‑assisted breast biopsy (VABB). Open biopsies are more invasive and are often done under general anaesthesia; image‑guided core biopsy and VABB are minimally invasive and are done under local anaesthesia.
Image‑guided core biopsies remove a single core of tissue from a lesion using a hollow needle. Several cores of tissue are often needed for accurate diagnosis, requiring multiple needle insertions into the breast.
The NHS Breast Screening Programme's clinical guideline on breast cancer screening assessment states that, where available, VACB (also known as VABB) may be considered the sampling method of choice for:
after a B1/B3/B4 result at 14‑gauge core biopsy
diagnostic excision of papillary lesions and radial scars or complex sclerosing lesions without atypia that have been diagnosed at core biopsy.
NICE is aware of the following CE‑marked devices that appear to fulfil a similar function to the ATEC breast biopsy system:
Original Mammotome (Devicor Medical Products)
EnCor (C. R. Bard).
List prices for the ATEC breast biopsy system and the components needed, excluding VAT, are tabulated in the appendix.
All 3 imaging modalities need an ATEC Sapphire console, which costs £15,000. One console may be used for all modalities. Per procedure prices for each imaging modality (including necessary components and excluding the ATEC Sapphire console price) are:
£239 for ultrasound image‑guided biopsies, which includes a disposable handpiece and a 9‑ or 12‑gauge needle, and an ATEC canister.
£245.50 for stereotactic image‑guided biopsies, which includes a disposable handpiece and a 9‑ or 12‑gauge needle, an ATEC canister and a 9‑ or 12‑gauge needle guide compatible with the imaging system. A reusable ATEC adapter at an additional one‑off cost of £3500 is also needed. Adapters are specific to the stereotactic imaging device used.
£459 for MRI‑guided biopsies, which includes a disposable MRI‑compatible handpiece and a 9‑gauge needle, an ATEC canister and an introducer localisation set.
An annual service contract is also available for the ATEC Sapphire console at a maximum annual cost of £1500.
The ATEC system would be used where VABB is indicated as an alternative to core needle biopsy or open biopsy.
According to specialist commentators, VABB is used to biopsy both B2 (pathologically benign) and B3 (atypical) lesions. VABB is also used to remove fibroadenomas and papillomas that have already been diagnosed through core biopsy. In addition, VABB is used to sample areas where more tissue is needed for diagnosis, for example, if microcalcification is detected during routine screening.
Three specialist commentators noted that VABB is unlikely to completely replace core biopsy, 1 of whom stated that, in their experience, core biopsy is the gold standard. However, another commentator stated that it is likely to be used in place of some open and core biopsies.
One specialist commentator stated that they would prefer a longer procedure with good quality samples and less bleeding instead of a fast procedure; quality of samples being important for histological assessment. This commentator felt that the evidence suggested the quality of samples obtained with the ATEC system may not be as good as those taken with other VABB systems. One specialist commentator stated that sample quality does not seem to have a bearing on the pathological accuracy, and therefore the ATEC system would not compromise outcomes. Another specialist commentator noted that VABB, regardless of the system used, produces larger quantities of tissue and the time taken for the pathologist to review them will be longer. The same specialist commentator noted that pathology services are already under pressure.
One specialist commentator added that the flexibility of the device, allowing it to be used with different imaging systems, is a significant advantage for hospital‑based services.
Two specialist commentators noted that the price of the ATEC system is comparable to competitor VABB systems. Another specialist commentator stated that an annual service contract is an attractive proposal.
Haematoma has been recorded as a complication in the included studies. Two specialist commentators noted that haematomas can occur with any VABB device and with core biopsies.
One specialist commentator stated that the evidence supports using this device in the clinical workplace. They noted that the time needed to take a biopsy sample would be of low importance but that the ATEC system appears to be faster than other VABB devices. However; they pointed out that the faster biopsy time has not reduced the number of complications observed.
One specialist commentator stated that the ATEC system would have a role in the practice of VABB and that it generally compares favourably with other devices on the market. Another specialist commentator noted that the device has a place in breast diagnostics and particularly in managing B3 lesions, but should not be considered as a replacement for first‑line core biopsy, considering the risk of haematoma.
NICE is committed to promoting equality and eliminating unlawful discrimination. In producing guidance and advice, NICE aims to comply fully with all legal obligations to:
promote race and disability equality and equality of opportunity between men and women
eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).
Although men and women can develop breast cancer, it is far more common in women. Additionally, the risk of developing breast cancer increases with age. Sex and age are protected characteristics under the Equality Act 2010. People diagnosed with cancer are considered to be disabled under the Act and are therefore protected from the point of diagnosis.