Inside SUMMIT RISE: Route 92 Medical on Reperfusion, Access, and What Comes Next

In March, Route 92 Medical enrolled its first patient in SUMMIT RISE, a 500-patient, 50-center, prospective real-world study evaluating the performance of the company's neurovascular intervention device portfolio across a range of stroke presentations, vessel anatomies, and clinical settings. The study builds on the clinical foundation of SUMMIT MAX, which documented the highest first-pass effect ever reported in a randomized endovascular thrombectomy trial, and is designed to generate comprehensive data across the full Route 92 Medical reperfusion system portfolio, including the HiPoint 88, the only FDA-cleared super-bore catheter system for direct aspiration in large vessel occlusion.

NeurologyLive^® spoke with Joey English, MD, Chief Medical Officer of Route 92 Medical, to discuss the rationale behind the study and what the company hopes to learn from it. Dr. English also addressed the design principles behind the company's integrated reperfusion platform and how vessel-matched catheter technology aims to simplify endovascular thrombectomy and extend access to a broader range of clinicians and hospital settings.

In this Q&A, Dr. English outlines the key innovations behind Route 92 Medical's platform, what SUMMIT RISE is designed to add beyond prior trials, which procedural endpoints will matter most, and how findings from the study could help inform best practices for stroke treatment across different hospital environments.

NeurologyLive: Can you briefly outline the key design features of Route 92 Medical’s reperfusion platform and how it differs from other aspiration-based thrombectomy approaches used in acute ischemic stroke?

Joey English, MD: There are three key innovations that power Route 92 Medical’s innovations.

First, our Base Camp sheath provides physicians with a stable access point, enabling them to efficiently advance devices from the groin into the cerebral vasculature.

Second, our Tenzing delivery catheters are designed to navigate tortuous neurovascular anatomy, allowing physicians to reach stroke-causing clots quickly while eliminating the need for multiple devices and simplifying the procedure.

Third, our HiPoint and FreeClimb reperfusion catheters are available in vessel-matched diameters including our Super bore .088” HiPoint catheter. These enable physicians to remove large clots from the brain. 

These product systems come in a full range of sizes and enable us to provide customers with a full portfolio to address the diversity of patient anatomies and clot type.

What were the primary motivations for launching SUMMIT RISE, and what additional insights do you hope this real-world study will provide beyond earlier trials like SUMMIT MAX?

We’re committed to continuing to build rigorous clinical evidence to support the adoption of our products, by developing the data to show their effectiveness in real-world use.

The SUMMIT RISE study builds upon the clinical foundation established by SUMMIT MAX and is designed to further strengthen our leadership in aspiration thrombectomy by studying a larger patient population, and the full portfolio of Route 92 Medical’s products.

This study will provide valuable insights into our performance across a broad range of users and patient anatomies, with the goal of reinforcing our strong patient outcomes.

Which clinical or procedural endpoints will be most important to monitor as you evaluate device performance across different stroke presentations and vessel anatomies?

There are three key procedural success factors that this study aims to understand: delivery, first pass effect, and safety.

Endovascular thrombectomy procedures are successful when the stroke-causing clot is removed completely, such that blood flows back into parts of the brain cut off by the clot. Thus, the first success factor is being able to deliver a catheter to the clot. Without success here, the procedure fails.

The second success factor, first pass effect, measures how often the clot can be completely removed on the first pass without the use of adjunctive devices. Since time is of the essence to enable patient recovery, first pass effect is an important measure of procedural effectiveness.

Finally, safety. We want to measure and understand the safety of our products both to ensure they remain safe and effective in a broader set of customer hands than our original studies, and to help customers understand real-world performance relative to other Route 92 Medical and competitive products.

How might the Super-bore design of the HiPoint 88 catheter influence factors such as clot retrieval efficiency or first-pass reperfusion rates in clinical practice?

Legacy aspiration systems were designed primarily to deliver the device to the clot and have not really focused on procedural simplicity. Many times, physicians can’t get to the correct location. They must attempt to access the clot multiple times or are only able to remove pieces of clot. These systems often involve multiple devices and require complicated catheter-in-catheter configurations. Or, the catheters that are delivered are much smaller than the blood vessel, so they are “too small of a straw” to remove the clot cleanly. As a result, procedures require multiple passes through delicate brain vessels.

At Route 92 Medical, our focus is on simplifying endovascular thrombectomy by providing clinicians with integrated tools designed to restore blood flow quickly, efficiently, and reliably, helping physicians to access and remove the clot and enable more successful patient outcomes. Vessel-size-matched catheters are a big part of this approach. In procedures using our technology, the “straw” and the clot are similarly sized, improving the potential to remove the clot on the first pass. Of note, our SUMMIT MAX study (with a super bore .088” reperfusion catheter) demonstrated this principle and achieved the highest first-pass effect ever documented in a randomized endovascular thrombectomy study. Further, with more clots removed completely on the first pass, there is less need for adjunctive devices (guidewire, stent retriever, etc.) that complicate procedures.

How could findings from SUMMIT RISE help inform best practices for endovascular stroke treatment across different hospital settings?

We want to empower clinicians using Route 92 Medical’s solutions with data that can enable technique refinement with insights about which solutions work best in given real world situations.

Beyond this, we hope to understand how our products work best in clinical workflows. Such insights may help us further refine endovascular thrombectomy procedures and democratize access to them across a broader range of clinicians and hospital settings. When procedural complexity is reduced, a wider range of hospitals and clinicians could perform endovascular thrombectomy procedures, potentially bringing access to these lifesaving procedures to many more communities.