NICO Corporation, a pioneer and leader in minimally invasive neurosurgery, today announced results from the completed ENRICH (Early MiNimally-invasive Removal of ICH) trial will be presented at the annual American Association of Neurological Surgeons (AANS) meeting in Los Angeles from April 21-24. The ENRICH trial results were accepted as a late-breaker and will be presented on Saturday, April 22 during an oral plenary session beginning at 8:30 a.m. PT (11:30 a.m. ET) by co-lead ENRICH investigator, Gustavo Pradilla, M.D., associate professor of neurosurgery at Emory University School of Medicine and chief of neurosurgery at Grady Memorial Hospital.
ENRICH2 was designed to evaluate the safety, efficacy, and economic outcomes in ICH, or hemorrhagic stroke, comparing MIPS using NICO’s complete technology solution comprised of BrainPath® and Myriad® versus standard of care, which is medical management based on American Heart Association/American Stroke Association guidelines. BrainPath was the first neurosurgery device to enable minimally disruptive, navigable, trans-sulcal access to the brain while Myriad offers multi-functional capabilities for automated, non-ablative hemorrhage evacuation.
“The ENRICH clinical trial represents almost seven years of dedication aiming to improve clinical outcomes for those who suffer from devastating hemorrhagic strokes,” said Jim Pearson, president and CEO, NICO Corporation. “To date, there has never been a positive randomized controlled trial demonstrating the benefit of surgical evacuation of ICH, so we eagerly await the results of the ENRICH trial at AANS. We also thank the entire stroke community for their efforts in supporting the trial, especially our partner, Emory University, the ENRICH investigators, stroke centers and coordinators, patients and caregivers for their support in delivering this scientific evidence.”
An ICH is bleeding close to the surface, or deep areas of the brain caused by the rupture of a damaged blood vessel in the head. As the amount of blood increases, the build-up of pressure can lead to brain damage, unconsciousness or even death. These types of strokes affect more than two million people each year and have high morbidity and mortality rates. Up to 50% of people will survive 30 days post-hemorrhage3. Hemorrhagic strokes cost the U.S. healthcare system more than $17 billion annually4 with incidence expected to increase due to an aging population and increased use of anticoagulants.
About NICO BrainPath® and NICO Myriad® System
NICO’s technological system solution is compromised of the patented NICO BrainPath® – the world’s first and only technology that achieves minimally-disruptive access using a trans-sulcal and parafascicular surgical approach. The NICO Myriad® provides automated non-ablative tumor removal and hemorrhage evacuation with the Automated Preservation System (APS) enabling intra-operative collection and biological preservation of tissue.
References
1 Qureshi, Adnan I., et al. “Changes in Cost and Outcome among US Patients with Stroke Hospitalized in 1990 to 1991 and Those Hospitalized in 2000 to 2001.” Stroke, vol. 38, no. 7, July 2007, pp. 2180–2184, https://doi.org/10.1161/strokeaha.106.467506 . Accessed 5 Dec. 2019.
2 Ratcliff, 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.
3 Macellari F, Paciaroni M, Agnelli G, Caso V. Neuroimaging in intracerebral hemorrhage. Stroke. (2014) 45:903–8. doi: 10.1161/STROKEAHA.113.00370
4 Greenberg, Steven M., et al. “2022 Guideline for the Management of Patients with Spontaneous Intracerebral Hemorrhage: A Guideline from the American Heart Association/American Stroke Association.” Stroke, vol. 53, no. 7, 17 May 2022, https://doi.org/10.1161/str.0000000000000407.
