NICO has announced that its complete technology solution, comprising BrainPath and Myriad, has gotten initial positive results in the ENRICH study (early minimally-invasive removal of intracerebral haemorrhage (ICH)) compared to standard of care (SOC).
NICO BrainPath is claimed to be the first and only technology that offers minimally-disruptive access using a trans-sulcal, parafascicular surgical approach.
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NICO Myriad enables surgeons to achieve automated, non-ablative removal of tumours and evacuation of haemorrhages. At the same time, the company’s Automated Preservation System is used for the intra-operative automated collection and biological preservation of tissue while minimising degradation.
The study’s objective was to evaluate the safety, effectiveness and economic outcomes of early minimally invasive parafascicular surgery (MIPS) utilising NICO’s complete technology solution in comparison to standard care for ICH or haemorrhagic stroke.
The SOC is medical management (MM) based on the guidelines of the American Heart Association/American Stroke Association guidelines.
A randomised and multi-centre clinical trial evaluated the standardised early MIPS approach in 300 patients suffering from spontaneous haemorrhagic stroke.
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By GlobalDataThe trial comprised 208 patients with a haemorrhage in the lobar region and 92 patients who had experienced it in the anterior basal ganglia area.
NICO president and CEO Jim Pearson said: “The results of the ENRICH trial are revolutionary and represent an advancement for improving outcomes for the millions of people who suffer haemorrhagic strokes.”
The utility-weighted modified Rankin Scale (UWmRS) was used to assess functional outcomes in the ENRICH trial at the end of six months.
The mean UWmRS score in the MIPS group was 0.458 compared to 0.374 in the MM group. The observed difference indicated that the treatment is superior to SOC with a 98.1% posterior probability of superiority.
