Route 92 Medical announced positive multicenter study results for their Monopoint system, a novel catheter technology designed for neurovascular interventions. The study, published in Stroke: Vascular and Interventional Neurology, demonstrated the system’s effectiveness in treating idiopathic intracranial hypertension (IIH) by facilitating venous sinus stenting. This is particularly relevant because the Monopoint system successfully navigated complex venous anatomy and enabled stent delivery, overcoming challenges posed by tortuous vessels and stenosis.
This advancement is important for IIH patients who experience debilitating symptoms like headaches, visual disturbances, and tinnitus. Current treatment options for IIH, particularly for cases involving venous stenosis, can be challenging due to the complex nature of the neurovasculature. The Monopoint system offers a potentially less invasive and more effective approach, potentially improving patient outcomes and quality of life by addressing the underlying venous outflow obstruction.
The study involved 71 procedures across 13 U.S. centers, representing the first investigation of the Monopoint system for venous sinus stenting. Results showed a 93% physician preference for the Monopoint system over conventional methods. The system’s unique design, featuring a single axial setup, large bore catheter, and variable length, contributed to its success in navigating challenging anatomy and deploying stents. This simpler approach may streamline procedures and potentially reduce complications associated with more complex multiaxial catheter setups.
This positive clinical data strengthens the position of the Monopoint system as a promising tool in neurovascular interventions. The system’s demonstrated efficacy in treating IIH may lead to wider adoption and further research into its applications for other neurovascular conditions. Ultimately, this technology has the potential to transform the treatment landscape for patients requiring complex neurovascular procedures.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
