Advice

Summary

Summary

The Somatom Definition Edge is a CT scanner that can be used for computed tomography coronary angiography (CTCA), to diagnose or evaluate coronary artery disease non-invasively in people with conditions that make it difficult to obtain good-quality CTCA images. The Somatom Definition Edge has technical features that are recognised to address clinical challenges in patients who have coronary artery disease that is difficult to image, but there is no published evidence on the safety or effectiveness for this indication. It can also be used for other clinical imaging applications in adults and children. The Somatom Definition Edge typically costs about £600,000 excluding VAT, depending on the configuration.

During the review process for diagnostics guidance on new generation cardiac CT scanners, NICE became aware of the Somatom Definition Edge CT scanner, which has similar technical specifications to those recommended in the guidance. NICE has also published a medtech innovation briefing on the Aquilion PRIME CT scanner.

Product summary and likely place in therapy

  • The Somatom Definition Edge CT scanner can be used to perform computed tomography coronary angiography (CTCA) to diagnose or evaluate coronary artery disease non‑invasively.

  • It would be used in adults with suspected or known coronary artery disease in whom:

    • revascularisation is being considered and

    • imaging with earlier generation CT is difficult.

      This includes people with obesity, high levels of coronary calcium, arrhythmias, high heart rates, stents or bypass grafts.

  • It can also be used for other clinical imaging applications in adults and children.

Effectiveness and safety

  • There is no published evidence on the safety or effectiveness of the Somatom Definition Edge scanner in people with difficult‑to‑image coronary artery disease. There is little evidence available on many CT scanner models in difficult‑to‑image subgroups because of the relatively rapid evolution of CT technology, particularly software enhancements.

Technical and patient factors

  • The Somatom Definition Edge is a single‑source, dual‑energy helical CT scanner. It has 64 detector rows, acquiring 128 slices per rotation via double sampling of the detector rows, and is capable of reconstructing 384 slices.

  • The scanner is suitable for all people in whom CT imaging is recommended, including adults (aged 18 years and over) with suspected or known coronary artery disease.

  • The scanner is intended for use in secondary care settings, specifically by trained radiographers who have the expertise to perform CTCA. Images are interpreted by radiologists or cardiologists.

Cost and resource use

  • The Somatom Definition Edge typically costs about £600,000 excluding VAT, depending on the configuration.

  • No published evidence on cost effectiveness or resource use was available for this scanner.