First-of-its-Kind Multicenter Study Demonstrates Utility of Monopoint System in Procedures to Treat Idiopathic Intracranial Hypertension

Monopoint system enables rapid access to the venous system

Research to be presented at SNIS Cerebral Venous and CSF Disorders Summit

SAN MATEO, Calif., March 19, 2025 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the results of a first-of-its-kind multicenter study published in Stroke: Vascular and Interventional Neurology, which demonstrated the utility of the Monopoint^® system in procedures to treat idiopathic intracranial hypertension (IIH).¹ Physicians participating in the study noted that the Monopoint system successfully navigated tortuous patient anatomy and crossed the stenosis, offering improved trackability and sufficient catheter length to enable successful stent delivery.

Intracranial hypertension (IIH) occurs when increased cerebrospinal fluid pressure or venous outflow obstruction leads to elevated intracranial pressure, causing headaches, visual disturbances, pulsatile tinnitus, cognitive and psychological symptoms. The annual incidence of IIH in the western world is approximately 0.9 per 100,000 persons (approximately 3,000 diagnoses per year in the U.S.), but primarily afflicts females with obesity.²

One potential treatment for IIH involves venous stenting and treats the IIH cases that are associated with a venous stenosis identified during imaging studies.³ Such treatment requires passing through tortuous vessels in the venous anatomy to deliver a stent.

The retrospective, multicenter, observational study aimed to understand the effectiveness of using the Monopoint system to access the venous sinus, cross through stenosis and allow delivery of a stent. The study included 71 patient procedures which took place between January 2022 and December 2023 at 13 high volume neurovascular centers in the U.S. This is the first such study using the Monopoint system to facilitate venous sinus stenting.

“Physicians participating in the study rated the Monopoint system as better than conventional approaches 93 percent of the time,” noted Tony Chou, M.D., founder and chief executive officer at Route 92 Medical. “The Monopoint system’s single axial setup and large bore catheter design makes it an ideal choice for complex neurovascular procedures, such as venous sinus stenting where physicians must navigate through tortuous anatomy and a stenosis to reach the target location.”

The Monopoint system is comprised of the Base Camp^® 8F Sheath, HiPoint^® 88 catheter, and Tenzing^® 8 delivery catheter, which solved length compatibility problems that occur with conventional systems. The study showed that the Monopoint system could support the deployment of relatively stiff stent systems. Such systems benefit from a large bore catheter which can reduce the need for complex multiaxial catheter access setups as well as over-the-wire exchange maneuvers. The variable catheter length of the Monopoint system and improved trackability through tortuous anatomy also supported the procedural success.

“We demonstrated that the flexibility of the Monopoint system, with a simple set up and a variable length, is extremely helpful in venous sinus stenting procedures where crossing stenosis to place venous stents can be challenging with less adaptable solutions,” said Oded Goren, M.D., associate professor of neurosurgery and director of vascular and endovascular neurosurgery at Geisinger Medical Center, Danville, Penn. “As a result of their venous sinus stenting procedures, study participants experienced a range of clinical improvements including a reduction in headaches, pulsatile tinnitus, and papilledema.”

Matthew Alexander, M.D., M.S., medical director at Sutter Medical Center Sacramento, will present the study at the Society of NeuroInterventional Surgery Cerebral Venous and CSF Disorders Summit being held March 19-21, 2025, in Honolulu, Hawaii. His presentation will be Friday, March 21, 2025, at 3:45 p.m.

The stents referenced in this publication are not approved for venous stenting. To learn more about the Monopoint system and other Route 92 Medical neurovascular intervention products, visit www.route92medical.com.

About Route 92 Medical
Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn.

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¹ Goren, Oded, M.D. et. Al. “Venous Sinus Stenting Using a Ledge-Reducing Catheter, 0.088-in. Catheter-Extender With an External Single Point of Control: Technique and Multicenter Clinical Experience.” Stroke: Vascular and Interventional Neurology. March 2025. Available: https://www.ahajournals.org/doi/epub/10.1161/SVIN.124.001627.
² Chen, John and Michael Wall. “Epidemiology and Risk Factors for Idiopathic Intracranial Hypertension.” Int. Ophthalmol. Clin. Winter 2014. Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC3864361/.
³ Fargen, Kyle M. “Venous Stenting for Idiopathic Intracranial Hypertension: Lessons Learned from High Volume Practice.” Journal of NeuroInterventional Surgery. 2022. Available: https://jnis.bmj.com/content/14/6/528.

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