Trial Findings for Minimally Invasive Parafascicular Technology Show Promise for Intracerebral Hemorrhage Treatment
Results of the trial suggest that early intervention for intracerebral hemorrhage using parafascicular surgery were safe.
Image Credit: Adobe Stock Images/Dr_Microbe
NICO Corporation announced that results from the ENRICH trial testing minimally invasive parafascicular surgery (MIPS) technology for intracerebral hemorrhage (ICH) show the procedure is safer than current methods of medical management. The results, published by the New England Journal of Medicine, indicated that early MIPS interventions using the company’s BrainPat and Myriad applications produced significant improvements in patient outcomes for ICH patients. This included a higher utility-weighted modified Rankin Scale at 180 days and reduced mortality rates at 30 days for patients treated with MIPS. Further, the company reported that the treatment decreased the overall number of ICU and hospital visits.1
"The results of the ENRICH trial not only demonstrate the efficacy and safety of MIPS, but they also herald a transformative milestone for the entire stroke community, changing the ICH treatment paradigm through a standardized approach and advanced technology," said Gustavo Pradilla, MD, co-lead investigator for ENRICH, associate professor of neurosurgery, Emory University School of Medicine, chief of neurosurgery, Grady Memorial Hospital, in a press release. "The ability to maximize the amount of clot evacuated in a safe manner is a pivotal advancement. We are steadfast in our commitment to collaborate with the medical community to educate on these interdisciplinary practices and foster their widespread adoption across institutions and specialties. Together, we aspire to significantly improve the outcomes and lives of ICH patients, caregivers and loved ones."
The ENRICH trial also achieved multiple secondary endpoints, including favorable regression analysis when it came to mRS in the MIPS group, a major 44 mL reduction in average hemorrhage volume, and a 73% achievement of end of treatment volume goal of <15mL.1
"With its high rates of morbidity and mortality and the combined cost of both acute treatment and long-term recovery, ICH is the costliest, most deadly, and debilitating form of stroke, but despite these facts, no surgical approach has produced level 1 evidence to intervene until now," said Jim Pearson, president, CEO, NICO Corporation, in the press release. "The success of our trial on MIPS for ICH demonstrates the pivotal role of safe and effective clot removal using our technology, coupled with early intervention. With intervention initiated within 24 hours, an average of 16 hours for trial participants, the MIPS group achieved a significant 88% median hematoma volume reduction and improved mortality compared to the standard of care. The results from the trial are clear: the more effectively and quickly we remove blood off of the brain, the greater the patient's chance of functional recovery and survival."
According to the American Stroke Association (ASA), hemorrhagic strokes make up approximately 13% of stroke cases, with close to half of patients dying within a month of hemorrhaging and one-quarter returning to functional independence. Strokes happens when a vessel ruptures and bleeds into the brain, which compresses the surrounding brain tissue.1,2
“Stroke is the No. 5 cause of death in the United States and a leading cause of disability,” reports the ASA. “Hemorrhagic strokes make up roughly 10 percent of the nearly 800,000 strokes that occur annually, and they have a higher mortality rate than other types of stroke. Hemorrhagic stroke patients who are treated with novel oral anticoagulants, or NOACs, have an in-hospital mortality rate of 26.5%.”3
References
1. 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). PR Newswire. April 11, 2024. Accessed April 15, 2024. https://www.prnewswire.com/news-releases/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-302114393.html
2. Hemorrhagic Stroke. ASA. Accessed April 15, 2024. https://www.stroke.org/en/about-stroke/types-of-stroke/hemorrhagic-strokes-bleeds
3. Hemorrhagic Stroke Initiative. ASA. Accessed April 15, 2024. https://www.heart.org/en/professional/quality-improvement/hemorrhagic-stroke
