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HARRISON, N.Y., Feb. 20, 2025 (GLOBE NEWSWIRE) — Serenity Medical, a NeuroTechnology Investors (NTI) portfolio company dedicated to the treatment of venous sinus stenosis, today announced the publication of The River Study: the first multicenter trial of a novel venous sinus stent for the treatment of Idiopathic Intracranial Hypertension (IIH) in the Journal of NeuroInterventional Surgery (JNIS). The publication reports one-year results for Serenity Medical’s River™ stent, a novel venous sinus stent, in patients with IIH who are refractory or intolerant to medications for this difficult-to-treat condition with no cure. IIH is characterized by increased intracranial pressure which causes debilitating headaches, progressive vision loss, ringing in the ears and brain fog, and is most commonly seen in young, overweight women. Most IIH patients progressively develop stenosis of the venous sinuses draining the cerebral blood from the brain. Without intervention, this stenosis may continue to worsen through a positive feed-back loop, creating a vicious cycle that increases the intracranial pressure even further.
“We are highly encouraged by the promising results of this first-of-its kind study with a stent specifically designed for intracranial venous sinuses,” said Adnan Siddiqui, MD, PhD, FAANS, FACS, FAHA, vice chairman and professor of neurosurgery, Jacobs School of Medicine & Biomedical Sciences and senior author on the paper. “Stents that are currently used in venous sinus stenting were not specifically developed for this purpose. As a dedicated venous device, the length, diameter, radial force, and flexibility of the River stent are optimized for the structure and unique mechanical properties of the area we are addressing. We are hopeful that it will offer the opportunity for benefit for patients whose lives are disrupted by IIH and have no options for treatment.”
Currently, the River stent is an investigational device and not commercially available. The River Trial was undertaken to obtain Humanitarian Device Exemption (HDE) approval of the stent and the company is currently working through the approval process with the US Food and Drug Administration (FDA). The study was a prospective, open-label, multicenter, single-arm trial which enrolled 39 subjects at five US centers and aimed to demonstrate safety and efficacy of the River stent, the first stent specifically designed for intracranial venous sinus use and the treatment of IIH in patients who are refractory or intolerant to medications. The River Study one-year results met the primary safety endpoint with a rate of major adverse event of 5.4%. Significant improvements were observed in opening CSF pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms, and Quality of Life scores.
“IIH has long perplexed the medical community and provided the impetus to address the need and develop a stent specifically designed to treat this patient population. We are particularly hopeful that this solution could offer benefit for patients who suffer from its symptoms and lack adequate treatment options,” said Y. Pierre Gobin, MD, founder of Serenity Medical and internationally recognized expert neurointerventionalist, practicing at Weill-Cornell Medicine in New York, NY.
The most common symptom is often an unbearably painful or frequent headache, sometimes associated with nausea and vomiting that is not relieved by medication. First line therapy is medical management including medications and weight loss. For patients with severe symptoms despite medical therapy or intolerance to medications, IIH has been treated surgically with either cerebrospinal fluid (CSF), shunting, optic nerve sheath fenestration (ONSF), and more recently venous sinus stenting. However, none of these surgical techniques or devices have been previously validated in a prospective controlled trial.
About Serenity Medical
Serenity Medical is developing a new approach to IIH. The company’s primary focus is on stenting the transverse-sigmoid sinus to relieve the various clinical symptoms of venous sinus stenosis. Its novel River™ stent, currently under clinical review by the FDA, is a highly flexible and longer stent designed specifically for the anatomy of the stenotic sinuses which is designed to eliminate the need for multiple stents. Its unique engineering also offers variable radial force and diameter to adapt to the anatomy and physiology of the sinuses, and features less metal surface area, aiming to minimize the risk of venous thrombosis. Visit the IIH hub for more information about treatment and resources for patients.
About Neuro Technology Investors (NTI)
NeuroTechnology Investors (NTI) is a leading investment group dedicated to advancing innovative neurological technologies and those in other specialties from the medical device sector. Established in 2016 and headquartered in Palo Alto, California, NTI investors lend their clinical expertise to add value to groundbreaking companies and accelerate access to clinical solutions for patients. To learn more, visit www.themdadvantage.com.
Media Contact:
Tara DiMilia
TellMed Strategies
tara.dimilia@tmstrat.com
908-884-7024
