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DYSIS Medical Ltd announces that the National Institute for Health and Care Excellence (NICE) has updated its original 2012 guidance on adjunctive colposcopy technologies, following a robust and in-depth analysis for a range of technologies. NICE reviewed all available clinical evidence on the performance of adjunctive colposcopy technologies using expert panel review. The new guidance from NICE states that “DYSIS is recommended” – an update from the original guidance of “should be considered”. DYSIS is currently the only adjunctive colposcopy technology recommended for routine adoption in the NHS cervical screening pathway.
DYSIS Colposcopy uses a proprietary spectral imaging technique to produce a map of the patient’s cervix. The DYSISmap highlights to clinicians potential areas of concern during the course of a normal colposcopic examination and uses a range of colours to indicate differing degrees of tissue status.
Multiple international clinical trials have shown that the use of DYSIS and the DYSISmap significantly improves the clinicians’ ability to detect pre-cancerous lesions of the cervix (high-grade cervical intraepithelial neoplasia). Armed with this additional information, immediate steps to treat patients and prevent disease progression can be taken, which in turn creates substantial economic benefits.
Most recently, DYSIS was the subject of the largest ever clinical study to evaluate the performance of colposcopy. The IMPROVE-COLPO study that was conducted in the USA compared DYSIS with conventional colposcopy and recruited 7,555 patients across 45 clinics. The study found (results published) that detection of precancerous lesions of the cervix was significantly higher with DYSIS.
Considering all available evidence and a health economics analysis, conducted by the University of York and specific to the NHS, NICE concluded that the available evidence supports the recommendation for DYSIS to be adopted within the NHS cervical screening programme.
Mr. Raj Naik, Consultant Gynaecological Oncologist and Clinical Director at the Northern Gynaecological Oncology Centre, (Queen Elizabeth Hospital, Gateshead, UK) said, “As an early adopter of DYSIS we have long been convinced of its merits and have directly seen the benefits through our own research. The additional information provided by DYSIS means clinicians can make more informed decisions on patient management and treatment. It also means that we can now challenge the old paradigm of automatically treating everyone with pre-cancerous lesions, currently classed as high grade, because DYSIS allows us to accurately monitor a patient over time and potentially avoid the need for treatment in certain patients.”
Alastair Atkinson, DYSIS Medical CEO, said, “This additional endorsement by NICE is highly influential in differentiating DYSIS as a vital contributor to women’s healthcare. The global recognition of NICE as a hallmark of excellence will help to endorse the adoption of DYSIS within the NHS and our other strategic markets as the new standard for colposcopy.”
The DYSIS Colposcope is now available in around 10% of NHS colposcopy clinics, used by over 800 clinicians worldwide and has performed in excess of 100,000 patient examinations.
About DYSIS Colposcope
The DYSIS Colposcope uses a proprietary technology to create an adjunctive map of the cervix that highlights areas of interest to a clinician and assists in the selection of appropriate biopsy points.
For Further Information
More on the gynecological device market in Europe can be found in a series of reports published by iData Research entitled the Europe Market Report Suite for Gynecological Devices. The suite covers reports on the following markets: assisted reproduction devices, endometrial ablation, endometrial resection, uterine fibroid embolization, hysteroscopes, colposcopes, transcervical female sterilization, female urinary incontinence slings, laser technology, fluid management equipment, pelvic organ prolapse repair devices and hysterosalpingography catheters.
The iData report series on gynecological devices covers the U.S., Asia-Pacific and 15 countries in Europe including Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about gynecological market data or procedure data, register online or email us at [email protected] for a Europe Market Report Suite for Gynecological Devices brochure and synopsis.