OUR APPROACH Validation and clinical development
PerfusionWorks has been developed through a structured engineering, analytical verification and clinical development programme designed to support robust, objective fluorescence analysis.
The platform continues to be evaluated through ongoing clinical collaborations to further assess performance, usability and clinical application in real world surgical environments. As fluorescence based perfusion assessment continues to evolve, ongoing evaluation will contribute to further refinement of the platform and support future clinical research into objective perfusion assessment.
In a retrospective colorectal video reader, PerfusionWorks demonstrated improvements in inter rater agreement and convergence of non expert assessments towards expert interpretation, supporting its role in providing objective, relative, reference based perfusion information.
DEVELOPMENT PROGRAMME
Development has incorporated recognised medical device software engineering principles together with close collaboration between software engineers, imaging scientists and clinicians experienced in fluorescence guided surgery.
The development programme has included:
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Software lifecycle engineering
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Fluorescence analysis algorithm development
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Analytical performance verification
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Performance testing
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Usability engineering
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Clinical workflow evaluation
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Clinical collaboration within gastrointestinal surgery and other fluorescence guided procedures
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Preparation of regulatory documentation to support MDR conformity assessment
THE FUTURE OF FGS
Enabling the next generation of clinical research
The future of fluorescence guided surgery extends beyond intraoperative visualisation. Objective, structured imaging data create datasets that can be analysed more consistently across patients, centres and studies.
As fluorescence based perfusion assessment techniques continue to develop, structured, relative, reference based data are expected to play an increasingly important role in strengthening clinical evidence and advancing fluorescence guided surgery.
PLATFORM TECHNOLOGY
Designed for surgical assessment support
PerfusionWorks has been developed as a platform technology for fluorescence guided surgery. Rather than focusing only on a single implementation, the platform architecture has been designed to support objective, relative, reference based assessment of tissue perfusion wherever fluorescence imaging is used to support intraoperative evaluation.
At present, PerfusionWorks is indicated to support the clinical decision process during video assisted fluorescence guided gastrointestinal surgery in adult patients. The underlying platform concept is intended to be adaptable to additional applications in the future, subject to supporting evidence and regulatory approvals.
Fluorescence guided perfusion assessment techniques are being explored across multiple surgical specialties, including colorectal and other gastrointestinal surgery, reconstructive procedures, cardiothoracic surgery, vascular surgery, gynaecology, surgical oncology, urology and ENT or maxillofacial surgery. PerfusionWorks has been designed with this broader evolution in mind, while its current indication focuses on gastrointestinal surgery.
THE BIGGER PICTURE
Advancing the future of fluorescence guided surgery
Fluorescence guided surgery has transformed intraoperative visualisation. The next stage of its evolution is the ability to complement visual information with objective, structured, relative, reference based data. PerfusionWorks has been developed to support this transition by combining objective fluorescence analysis with established surgical workflows, helping clinicians generate structured perfusion information that complements visual assessment and clinical expertise.
As structured fluorescence data and objective assessment techniques continue to mature, they have the potential to support more consistent interpretation, contribute to efforts towards greater standardisation and strengthen the clinical evidence base for fluorescence guided surgery. PerfusionWorks aims to contribute to this future by providing objective, relative, reference based perfusion information that supports more data informed surgical practice while maintaining the central role of surgeon judgement.
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