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Surgery is one of the most dramatic examples of the importance of getting things ‘right first time’. Get it wrong and there may not be a second chance for the patient. That’s what makes the latest developments in navigation and visualisation techniques particularly exciting – they have the potential to transform the world of surgery.
Significant advances have already been achieved in surgical navigation and visualisation for tumour detection and location, although robust intrasurgical margin assessment is still a challenge. Currently, the use of imaging for guidance during surgical interventions has been limited to incidental use of intraoperative X-ray fluoroscopy and ultrasonography. However, there is a rapidly developing landscape for novel technologies which will uncover the detailed microstructure of tumour pathologies in situ – and provide surgeons with new tools and techniques for successful patient diagnosis and treatment.
Many novel products being developed have their origins in cancer diagnosis. For example, NinePoint Medical launched NvisionVLE as a diagnostic biopsy imaging system for oesophageal cancer, obtaining FDA and European approvals in 2012. This technology uses optical coherence tomography (OCT) to provide high-resolution imaging of the surface of the cancer.
Similarly, Mauna Kea Technologies launched its Cellvizio laser confocal endomicroscopy ‘optical biopsy’ system for diagnosis in gastrointestinal, pulmonary and urinary systems in 2011. Last year it received FDA approvals to begin the transition from a purely diagnostic technology to a surgical intervention technology.
We have identified at least 70 novel intraoperative imaging technologies in research and development, which promise to delineate between cancer and normal tissue during operative procedures – or by rapid characterisation of resected tissue samples within the operating room. Although the majority of technologies are based on optical/visualisation recognition, alternative non-optical technologies also exist.
Much attention has been paid recently to two emerging technologies being used in the surgical excision of brain cancer. The first of these is a Raman spectroscopy system, being developed at McGill University in Canada, which uses lasers to diagnose abnormal tissue. The second is the iKnife, which is a rapid evaporative ionisation mass spectrometry (REIMS) device developed at Imperial College, London. This ‘intelligent’ knife can give a detailed molecular analysis of tissue.
OCT is now becoming a key focus of devices being developed to help surgeons recognise tumour margins and critical structures during surgery – such as cavernous nerve and periprostatic tissues during prostate cancer excision (University of Florida) and the in situ measurement of tumour margins of breast cancer under ultrasound guidance (University of Western Australia).
Although many of these technologies require proof of overall clinical benefit and cost effectiveness, Dune Medical Devices has developed an electromagnetic assessment of tumour margins using fringe field sensing, which – in its trials – has already been proven to reduce reoperation rates in breast conserving surgery by 56%. Reoperation rates currently run at around 20% in England for this type of cancer treatment.
At the heart of these novel devices are new generations of sensing, visualisation and positioning technologies – which plays to the strength of our expertise in developing world-class products to improve surgical outcomes.