The New England Journal of Medicine Publishes Complete Data from ENRICH, the First Positive Trial to Improve Functional and Economic Outcomes for Intracerebral Hemorrhage (ICH)
NICO Corporation, a leader in minimally invasive parafascicular surgery (MIPS), has announced the publication of complete ENRICH (Early MiNimally-invasive Removal of ICH) trial data in the New England Journal of Medicine. The trial showcased the efficacy of NICO’s technology, BrainPath® and Myriad®, in treating intracerebral hemorrhage (ICH), the most deadly, costly and disabling form of stroke.
ENRICH met its primary endpoints showing MIPS improved outcomes for ICH patients with statistically significant improvement in utility-weighted modified Rankin Scale (UWmRS) at 180-days (0.458) versus MM (0.374), the difference showing a 98.1% posterior probability of superiority (95% CI, 0.005 to 0.163) and reduced mortality at 30-days (9.3%) compared to MM (18.1%). Additionally, the MIPS approach significantly decreased ICU length of stay (LOS) by 2.8 days and hospital LOS by 3.1 days.
The trial utilized NICO’s technological system solution, comprised of our patented technologies including the NICO BrainPath® – the world’s first and only technology that achieves minimally-disruptive access using a trans sulcal and parafascicular surgical approach – and the NICO Myriad® that provides automated non-ablative tumor removal and hemorrhage evacuation.
Globally, 3.4 million people suffer hemorrhagic strokes (ICH) each year.1 While ICH comprises up to 20 percent of all strokes that occur compared to ischemic stroke,1 mortality and long-term disability are disproportionately higher among ICH patients.2 In the United States, up to 50 percent will die within 30 days post-hemorrhage, and among survivors, only 25 percent will return to functional independence.2 In addition to the human toll, hemorrhagic stroke costs the U.S. healthcare system approximately $17 billion, with $12 billion in estimated annual costs of care and productivity losses for survivors.3
Overall, the trial showed early MIPS intervention for ICH led to improved functional outcomes, increased safety, and demonstrated statistically significant economic improvements.
Read the Press Release here:
This episode of Your Fantastic Mind highlights the ENRICH trial and the promising surgical treatment, MIPS with NICO Technologies, which offers hope to patients affected by ICH
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References
1Collaborators GBDS. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol 2021;20:795-820
2Macellari F, Paciaroni M, Agnelli G, Caso V. Neuroimaging in intracerebral hemorrhage. Stroke. (2014) 45:903–8. doi: 10.1161/STROKEAHA.113.00370
3Ratcliff, Jonathan J., et al. “Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH): Study Protocol for a Multi-Centered Two-Arm Randomized Adaptive Trial.” Frontiers in Neurology, vol. 14, 16 Mar. 2023, https://doi.org/10.3389/fneur.2023.1126958. Accessed 29 Mar. 2023.