Michael Barbella, Managing Editor06.08.23
NICO Corporation has released initial positive results from the completed ENRICH (Early MiNimally-invasive Removal of ICH) trial. ENRICH was designed to evaluate the safety, efficacy, and economic outcomes for ICH, or hemorrhagic stroke, comparing early minimally invasive parafascicular surgery (MIPS) using NICO’s complete technology solution including BrainPath and Myriad versus standard of care, which is medical management (MM) based on American Heart Association/American Stroke Association guidelines. Two million people suffer hemorrhagic strokes each year and up to 50% of people will die within 30 days.1 For survivors, up to 88% will be dependent on others for activities of daily living six months later and only 25% will return to functional independence.
At six months, functional outcomes in ENRICH were assessed using the utility-weighted modified Rankin Scale (UWmRS) with differences greater than zero corresponding to improved outcomes. The mean UWmRS score was 0.458 in the MIPS group and 0.374 in those receiving MM, the difference showing a 98.1% posterior probability of superiority. These results met the primary endpoint demonstrating the MIPS group achieved a statistically significant and clinically meaningful improvement in UWmRS versus MM. The ENRICH study also found MIPS was safe and overall mortality at six months was 21.7% (20% for MIPS, 23.3% in the MM group). In the MIPS group, the median hematoma evacuation was 88% with a median end-of treatment volume (EOTV) of 7.2mL. Overall, 73% achieved the EOTV goal of <15mL, which is considered the surgical standard in clot evacuation.3
“The results of the ENRICH trial are revolutionary and represent an advancement for improving outcomes for the millions of people who suffer hemorrhagic strokes,” NICO Corporation President/CEO Jim Pearson said. “For more than a decade, NICO has been committed to delivering the science and tools behind minimally invasive neurosurgery for the ICH population and ENRICH is the culmination of our mission. We are thrilled to bring these results to the physicians, patients and caregivers of the hemorrhagic stroke community.”
The ENRICH trial is a randomized, multi-center, adaptive, clinical trial designed to evaluate the effectiveness, safety and economics of a standardized early MIPS approach (within 24 hours) in 300 patients with spontaneous hemorrhagic stroke—92 patients with a hemorrhage in the anterior basal ganglia (ABG) location and 208 in the lobar location. The primary intention-to-treat analysis evaluated whether the UWmRS, a standardized measure of global disability, at 180 days in the treatment group was superior to that of the control group. The safety endpoints were mortality at 30 days, change in hemorrhage volume between index and 24-hour CT scan while the economic endpoints were quality-adjusted life years (QALY) at 90-, 120- and 180-days post hemorrhage. The randomized trial enrolled patients at 37 stroke centers across the United States.2
“ENRICH is the first, randomized clinical trial to meet its primary endpoint demonstrating early MIPS with BrainPath and Myriad improves outcomes for these deadly strokes,” said Gustavo Pradilla, M.D., co-lead investigator for ENRICH, associate professor of neurosurgery at Emory University School of Medicine and chief of neurosurgery at Grady Memorial Hospital in Atlanta. “I believe this trial will change how we treat hemorrhagic stroke moving forward and I look forward to sharing the further details of the ENRICH trial, which will be published soon.”
Dan Barrow, the Pamela R. Rollins Chairman and Professor of Neurosurgery at Emory University added, “We are grateful to NICO for their support of our research and our colleagues at the 37 participating sites that so carefully randomized and expertly managed the enrolled patients. Principally, we thank our patients and their families for entrusting us with their care and agreeing to participate in a trial to advance scientific knowledge for the benefit of others. Their selfless behavior is necessary to advance the scientific basis of medical care.”
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 buildup of pressure can lead to brain damage, unconsciousness or even death. These types of strokes affect more than 2 million people each year and have high morbidity and mortality rates. Up to 50% of people will die 30 days post-hemorrhage.1 Hemorrhagic strokes cost the U.S. healthcare system more than $12 billion annually4 with incidence expected to increase due to an aging population and increased use of anticoagulants.1
NICO’s technological system solution is comprised of two technologies which are patented, 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 with the Automated Preservation System enabling intra-operative collection and biological preservation of tissue.
NICO claims to be the world's only company to develop and patent technologies to create a new minimally invasive surgical market in neurosurgery for subcortical and skull base lesions. NICO technologies have been featured in more than 180 peer-reviewed publications with over 550 unique authors from major academic centers. Data from these publications suggest improved clinical outcomes in minimally invasive parafascicular surgery (MIPS).
References
1-4 Macellari F, Paciaroni M, Agnelli G, Caso V. Neuroimaging in intracerebral hemorrhage. Stroke. (2014) 45:903–8. doi: 10.1161/STROKEAHA.113.00370
At six months, functional outcomes in ENRICH were assessed using the utility-weighted modified Rankin Scale (UWmRS) with differences greater than zero corresponding to improved outcomes. The mean UWmRS score was 0.458 in the MIPS group and 0.374 in those receiving MM, the difference showing a 98.1% posterior probability of superiority. These results met the primary endpoint demonstrating the MIPS group achieved a statistically significant and clinically meaningful improvement in UWmRS versus MM. The ENRICH study also found MIPS was safe and overall mortality at six months was 21.7% (20% for MIPS, 23.3% in the MM group). In the MIPS group, the median hematoma evacuation was 88% with a median end-of treatment volume (EOTV) of 7.2mL. Overall, 73% achieved the EOTV goal of <15mL, which is considered the surgical standard in clot evacuation.3
“The results of the ENRICH trial are revolutionary and represent an advancement for improving outcomes for the millions of people who suffer hemorrhagic strokes,” NICO Corporation President/CEO Jim Pearson said. “For more than a decade, NICO has been committed to delivering the science and tools behind minimally invasive neurosurgery for the ICH population and ENRICH is the culmination of our mission. We are thrilled to bring these results to the physicians, patients and caregivers of the hemorrhagic stroke community.”
The ENRICH trial is a randomized, multi-center, adaptive, clinical trial designed to evaluate the effectiveness, safety and economics of a standardized early MIPS approach (within 24 hours) in 300 patients with spontaneous hemorrhagic stroke—92 patients with a hemorrhage in the anterior basal ganglia (ABG) location and 208 in the lobar location. The primary intention-to-treat analysis evaluated whether the UWmRS, a standardized measure of global disability, at 180 days in the treatment group was superior to that of the control group. The safety endpoints were mortality at 30 days, change in hemorrhage volume between index and 24-hour CT scan while the economic endpoints were quality-adjusted life years (QALY) at 90-, 120- and 180-days post hemorrhage. The randomized trial enrolled patients at 37 stroke centers across the United States.2
“ENRICH is the first, randomized clinical trial to meet its primary endpoint demonstrating early MIPS with BrainPath and Myriad improves outcomes for these deadly strokes,” said Gustavo Pradilla, M.D., co-lead investigator for ENRICH, associate professor of neurosurgery at Emory University School of Medicine and chief of neurosurgery at Grady Memorial Hospital in Atlanta. “I believe this trial will change how we treat hemorrhagic stroke moving forward and I look forward to sharing the further details of the ENRICH trial, which will be published soon.”
Dan Barrow, the Pamela R. Rollins Chairman and Professor of Neurosurgery at Emory University added, “We are grateful to NICO for their support of our research and our colleagues at the 37 participating sites that so carefully randomized and expertly managed the enrolled patients. Principally, we thank our patients and their families for entrusting us with their care and agreeing to participate in a trial to advance scientific knowledge for the benefit of others. Their selfless behavior is necessary to advance the scientific basis of medical care.”
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 buildup of pressure can lead to brain damage, unconsciousness or even death. These types of strokes affect more than 2 million people each year and have high morbidity and mortality rates. Up to 50% of people will die 30 days post-hemorrhage.1 Hemorrhagic strokes cost the U.S. healthcare system more than $12 billion annually4 with incidence expected to increase due to an aging population and increased use of anticoagulants.1
NICO’s technological system solution is comprised of two technologies which are patented, 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 with the Automated Preservation System enabling intra-operative collection and biological preservation of tissue.
NICO claims to be the world's only company to develop and patent technologies to create a new minimally invasive surgical market in neurosurgery for subcortical and skull base lesions. NICO technologies have been featured in more than 180 peer-reviewed publications with over 550 unique authors from major academic centers. Data from these publications suggest improved clinical outcomes in minimally invasive parafascicular surgery (MIPS).
References
1-4 Macellari F, Paciaroni M, Agnelli G, Caso V. Neuroimaging in intracerebral hemorrhage. Stroke. (2014) 45:903–8. doi: 10.1161/STROKEAHA.113.00370
