Route 92 Medical announced positive real-world results for its HiPoint Reperfusion System, a catheter system used to treat acute ischemic stroke. An independent study showed high success rates in restoring blood flow to the brain using the HiPoint system. The company also launched a new 500-patient study, SUMMIT RISE, to further evaluate its neurovascular intervention portfolio.
These results are important because they offer further validation of the HiPoint system’s effectiveness outside of clinical trials, potentially influencing treatment guidelines and adoption by more hospitals. The high success rate in delivering the catheter to the occlusion site (96.2%) and achieving first-pass reperfusion (mTICI 2c/3 in 57.5% and mTICI 2b/2c/3 in 68.4% of cases) suggests the system can quickly restore blood flow, which is crucial for minimizing brain damage in stroke patients. The initiation of the SUMMIT RISE study demonstrates a commitment to gathering comprehensive real-world data, which is valuable for clinicians, payers, and patients seeking evidence-based treatment options.
The real-world study included 193 patients and focused on first-pass reperfusion rates and successful catheter delivery. The median number of passes required to achieve reperfusion was just one, indicating efficiency in the procedure. The upcoming SUMMIT RISE study will be prospective and core-lab-adjudicated, encompassing a larger patient population and a broader range of cases using Route 92 Medical’s neurovascular devices.
The positive real-world data and the comprehensive SUMMIT RISE study position Route 92 Medical to strengthen its market position in neurovascular intervention. The combined evidence from these initiatives could lead to wider adoption of the HiPoint system, potentially improving patient outcomes and reducing the long-term disabilities associated with stroke. The findings from SUMMIT RISE will provide further insight into the efficacy and optimal use of Route 92 Medical’s technology, driving innovation and improvements in stroke care.
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.
