Route 92’s Monopoint Venous Sinus System Studied to Treat Idiopathic Intracranial Hypertension

March 19, 2025—Route 92 Medical, Inc. announced the results of a multicenter study evaluating the utility of the company’s Monopoint venous sinus system in neurovascular interventional procedures to treat idiopathic intracranial hypertension.

According to the company, 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 that took place between January 2022 and December 2023 at 13 high-volume neurovascular centers in the United States.

As summarized in Route 92’s press release, investigators found 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. This is the first study using the Monopoint system to facilitate venous sinus stenting, advised the company. The findings were published by Oded Goren, MD, et al in Stroke: Vascular and Interventional Neurology.

“We demonstrated that the flexibility of the Monopoint system, with a simple setup 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,” commented Dr. Goren in the company’s press release. “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.” Dr. Goren is Associate Professor of Neurosurgery and director of vascular and endovascular neurosurgery at Geisinger Medical Center in Danville, Pennsylvania.

The Monopoint system is comprised of the Base Camp 8-F sheath, HiPoint 88 catheter, and Tenzing 8 delivery catheter.

The company stated that the study showed that the Monopoint system could support the deployment of relatively stiff stent systems, which benefit from a large-bore catheter that 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. The stents referenced in the study are not approved for venous stenting, advised the company.

Matthew Alexander, MD, will present the study at the Society of NeuroInterventional Surgery’s SNIS Cerebral Venous and CSF Disorders Summit held in Honolulu, Hawaii, on March 19-21, 2025. Dr. Alexander is medical director at Sutter Medical Center, Sacramento in Sacramento, California.