Nice develops medtech innovation briefing for Xstrahl distributed xoft axxent electronic brachytherapy system

NICE (National Institute for Health and Care Excellence) has announced a new Medtech Innovation Briefing (MIB)¹ stating that NHS doctors and commissioners may consider Single Dose Intraoperative Radiotherapy (SD-IORT) using Xstrahl distributed Xoft Axxent eBx as a treatment option for early stage breast cancer patients. A single dose of intraoperative radiotherapy (IORT) is an effective and convenient alternative to daily conventional radiotherapy for appropriate early stage breast cancer patients².

For most patients, IORT eliminates the need for post-operative radiotherapy, avoiding the inconvenience, disruption and expense of attending daily hospital appointments for several weeks. Women who receive IORT rather than EBRT have been shown to experience less pain, breast and arm symptoms, as well as fewer restrictions in daily activities.

Other benefits include:

Surgery and radiotherapy in just one day.

Reduces exposure of surrounding normal tissue to radiation dose.

Provides better cosmetic results.

For most patients, IORT eliminates the need for post-operative radiotherapy.

Offers improved quality of life and convenience compared to EBRT.

The NICE MIB states that the Xoft system would fit in the current NHS pathway, in place of external beam radiotherapy (EBRT), alleviating the need for patients to attend daily radiotherapy for 3 weeks. One of the MIB specialist commentators noted that SD-IORT was well tolerated with a low rate of adverse events and excellent to good cosmetic outcomes. As it is a portable platform SD-IORT can be delivered in a greater number of hospitals, which improves accessibility and convenience for the patient.

About Xoft
Xstrahl are the distributors of the Xoft® Axxent eBx System in the UK. Axxent is FDA cleared, CE marked and licensed in a growing number of countries including the UK for the treatment of cancer^3,4. The Xoft® Axxent eBx System is a simple-to-use, portable SD-IORT device, which utilises a disposable miniature X-ray tube (50kV). Minimal radiation shielding is required, avoiding the need to adjust operating theatres and enabling medical personnel to remain with the patient during treatment. For more information on Xoft® please visit: http://www.xoftinc.com/

About NICE MIB’s
NICE medtech innovation briefings (MIBs) are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The briefings will help avoid the need for organisations to produce similar information locally, saving staff time and resources. The information provided includes a description of the technology, how it’s used and it’s potential role in the treatment pathway.

A MIB also includes a review of relevant published evidence and the likely costs of using the technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.

MIBs are commissioned by NHS England and produced in support of the NHS 5-Year Forward View, specifically as one of a number of steps, which will accelerate innovation in new treatments and diagnostics.

References

1. NICE National Institute for Health and Care Excellence. Medtech Innovation Briefings. Available at:https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/medtech-innovation-briefings. Last accessed: July 2016
2. Vaidya JS et al. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet 2014;383:603–13.
3. U.S. Food and Drugs Administration. Tab 5 510 (k) Summary k090914. July 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/k090914.pdf. Last accessed July 2016.
4. Medical Devices Safety Service. Certificate of CE Marking for Xoft Inc. 2 December 2011. Available on request.NICE (National Institute for Health and Care Excellence) has announced a new Medtech Innovation Briefing (MIB)¹ stating that NHS doctors and commissioners may consider Single Dose Intraoperative Radiotherapy (SD-IORT) using Xstrahl distributed Xoft Axxent eBx as a treatment option for early stage breast cancer patients. A single dose of intraoperative radiotherapy (IORT) is an effective and convenient alternative to daily conventional radiotherapy for appropriate early stage breast cancer patients².For most patients, IORT eliminates the need for post-operative radiotherapy, avoiding the inconvenience, disruption and expense of attending daily hospital appointments for several weeks. Women who receive IORT rather than EBRT have been shown to experience less pain, breast and arm symptoms, as well as fewer restrictions in daily activities.Other benefits include:Surgery and radiotherapy in just one day.Reduces exposure of surrounding normal tissue to radiation dose.Provides better cosmetic results.

   For most patients, IORT eliminates the need for post-operative radiotherapy.

   Offers improved quality of life and convenience compared to EBRT.

   The NICE MIB states that the Xoft system would fit in the current NHS pathway, in place of external beam radiotherapy (EBRT), alleviating the need for patients to attend daily radiotherapy for 3 weeks. One of the MIB specialist commentators noted that SD-IORT was well tolerated with a low rate of adverse events and excellent to good cosmetic outcomes. As it is a portable platform SD-IORT can be delivered in a greater number of hospitals, which improves accessibility and convenience for the patient.

    

   About Xoft
   Xstrahl are the distributors of the Xoft® Axxent eBx System in the UK. Axxent is FDA cleared, CE marked and licensed in a growing number of countries including the UK for the treatment of cancer^3,4. The Xoft® Axxent eBx System is a simple-to-use, portable SD-IORT device, which utilises a disposable miniature X-ray tube (50kV). Minimal radiation shielding is required, avoiding the need to adjust operating theatres and enabling medical personnel to remain with the patient during treatment. For more information on Xoft® please visit: http://www.xoftinc.com/

    

   About NICE MIB’s
   NICE medtech innovation briefings (MIBs) are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The briefings will help avoid the need for organisations to produce similar information locally, saving staff time and resources. The information provided includes a description of the technology, how it’s used and it’s potential role in the treatment pathway.

   A MIB also includes a review of relevant published evidence and the likely costs of using the technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.

   MIBs are commissioned by NHS England and produced in support of the NHS 5-Year Forward View, specifically as one of a number of steps, which will accelerate innovation in new treatments and diagnostics.

    

   References

   1. NICE National Institute for Health and Care Excellence. Medtech Innovation Briefings. Available at:https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/medtech-innovation-briefings. Last accessed: July 2016
   2. Vaidya JS et al. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet 2014;383:603–13.
   3. U.S. Food and Drugs Administration. Tab 5 510 (k) Summary k090914. July 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/k090914.pdf. Last accessed July 2016.
   4. Medical Devices Safety Service. Certificate of CE Marking for Xoft Inc. 2 December 2011. Available on request.