Perfuze Reports Strong Final MARRS Pivotal Study Results Supporting Millipede88 Aspiration System in Acute Ischemic Stroke
Perfuze, a medical device company focused on advancing stroke intervention through next-generation catheter technology, has announced the publication of final results from its MARRS pivotal study in the Journal of NeuroInterventional Surgery. The findings provide clinical evidence supporting the use of the company’s Millipede® Aspiration System as a standalone direct aspiration approach for patients experiencing large vessel occlusion (LVO) stroke.
The prospective study achieved its primary endpoint, demonstrating successful reperfusion, defined as modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3, in 89% of patients without the use of rescue therapy. This result exceeded the study’s prespecified performance goal. In addition, the study showed a 75% first-pass effect, defined as mTICI 2c-3 reperfusion after a single thrombectomy pass, among patients with middle cerebral artery M1 occlusions. Delivery success with the Millipede88 catheter was reported at 96%.
The MARRS findings represent an important milestone for Perfuze as the company seeks to advance aspiration-based approaches to mechanical thrombectomy. The results were generated through a prospective, multicenter, single-arm pivotal investigation involving 180 patients treated at 22 hospitals across the United States and Europe. The study was conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), with imaging and safety endpoints independently adjudicated.
The clinical evidence generated through MARRS contributed to the FDA 510(k) clearance of the Millipede88 Aspiration Catheter, strengthening the regulatory foundation for Perfuze’s super-bore aspiration technology.
MARRS Study Evaluates Direct Aspiration for Stroke Treatment
Acute ischemic stroke caused by large vessel occlusion is a medical emergency in which rapid restoration of blood flow to the brain can be critical to limiting neurological damage. Mechanical thrombectomy has become an established treatment for eligible patients with LVO stroke, with physicians using catheter-based devices to remove blood clots from blocked cerebral arteries.
Aspiration thrombectomy is one of the techniques used to remove these clots. In a direct aspiration approach, a large-bore catheter is navigated to the clot and suction is applied to capture and remove the thrombus. The objective is to achieve effective reperfusion as quickly as possible while minimizing the number of device passes and the need for additional thrombectomy devices.
The MARRS study was designed to evaluate the performance and safety of Perfuze’s Millipede Aspiration System in this setting. The study included 180 patients and was conducted at 22 hospitals in the U.S. and Europe. Because the investigation was prospective and multicenter, the resulting dataset provides clinical evidence across multiple stroke treatment centers rather than being based on a single institution’s experience.
The independent adjudication of imaging and safety outcomes also provides an additional level of rigor to the reported results.
According to the final findings, successful reperfusion of mTICI 2b-3 was achieved in 89% of patients without rescue therapy. Rescue therapy was required in fewer than 8% of Millipede88 cases, meaning that the majority of procedures could be completed without the addition of an adjunctive device such as a stent retriever.
High First-Pass Performance in M1 Occlusions
One of the notable findings from MARRS was the reported 75% first-pass effect of mTICI 2c-3 in middle cerebral artery M1 occlusions. The first-pass effect is an important measure in mechanical thrombectomy because it reflects the ability to achieve substantial reperfusion during the initial attempt at clot removal.
Reducing the number of passes may help simplify procedures and potentially reduce the duration of vessel manipulation. For physicians treating time-sensitive ischemic stroke, achieving effective reperfusion on the first attempt can therefore be an important procedural objective.
Raul G. Nogueira, MD, a principal investigator of the MARRS study and affiliated with University of Pittsburgh Medical Center, emphasized the importance of first-pass performance in thrombectomy procedures.
“In large vessel occlusion stroke, the first pass is where outcomes are decided,” Nogueira said. He added that the first-pass effect and successful reperfusion rates observed in MARRS, based on independent core laboratory adjudication, were among the highest reported in a prospective thrombectomy study.
The results are particularly relevant to the continued evolution of aspiration-first strategies, in which physicians seek to use aspiration as the initial thrombectomy technique rather than routinely combining aspiration with other devices.
Millipede88 Uses Corrugated Catheter Architecture
At the center of the MARRS investigation is the Millipede88 Aspiration Catheter, which features a super-bore 0.088-inch inner diameter and Perfuze’s patented Corrugated™ technology.
The company says the catheter’s architecture differs from the coiled or braided construction used in conventional aspiration catheters. The Corrugated design is intended to preserve the integrity of the catheter’s inner lumen, supporting the maintenance of aspiration force at the face of the clot.
Catheter design is particularly important in aspiration thrombectomy because the effectiveness of suction depends on the ability to deliver and maintain sufficient aspiration force at the thrombus. A large internal lumen can support high-volume aspiration, while the structural characteristics of the catheter need to enable navigation through the cerebral vasculature.
Perfuze has designed the Millipede system around the concept that a super-bore catheter can provide a combination of aspiration capability and procedural efficiency. The MARRS findings provide clinical data supporting this design approach.
Favorable Safety Findings
In addition to evaluating reperfusion and procedural performance, the MARRS study assessed safety outcomes. The final results showed a symptomatic intracranial hemorrhage rate of 2.3%. Importantly, the study reported no vessel perforations and no device-related serious adverse events.
Safety is a central consideration in mechanical thrombectomy because catheter and device manipulation takes place within delicate cerebral blood vessels. Complications such as intracranial hemorrhage or vessel perforation can have serious consequences for stroke patients.
The safety results reported in MARRS therefore add another component to the clinical evidence supporting the Millipede88 system. The combination of successful reperfusion, first-pass performance, delivery success and safety outcomes provides a broader assessment of the device than reperfusion efficacy alone.
Perfuze Expands Super-Bore Aspiration Portfolio
Wayne Allen, CEO of Perfuze, said the final MARRS findings reinforce the design principles behind the Millipede system.
According to Allen, the results support the concept that a super-bore catheter engineered specifically for aspiration could help simplify stroke intervention while improving reperfusion performance. He highlighted the 75% first-pass effect observed in M1 occlusions as a clinically meaningful finding for standalone direct aspiration.
The company believes these results position Perfuze strongly within the emerging super-bore aspiration segment of the mechanical thrombectomy market.
As stroke centers increasingly consider aspiration-first approaches, catheter technology capable of delivering high aspiration performance is becoming an important area of development. Larger-bore aspiration systems are designed to provide physicians with increased aspiration capability while maintaining access to the target vessel.
Perfuze is currently conducting a Limited Market Release of the Millipede88 Aspiration System at selected U.S. Comprehensive Stroke Centers. The company plans to expand commercialization following this initial market introduction.
Integrated Access and Aspiration System
The Millipede88 Aspiration System is also part of Perfuze’s broader product strategy. The company recently received clearance for its Zipline® Access Catheter, which is designed to complement the Millipede88 within an integrated stroke intervention system.
By combining access and aspiration technologies, Perfuze aims to provide physicians with a streamlined platform for thrombectomy procedures. The company says the system is designed with the goal of supporting high first-pass effect and procedural efficiency.
The final MARRS publication consequently represents more than a single clinical milestone for Perfuze. It provides prospective clinical evidence for the company’s approach to super-bore direct aspiration while supporting the commercial development of its Millipede88 technology.
With 89% successful reperfusion without rescue therapy, a 75% first-pass effect in M1 occlusions, 96% delivery success and favorable reported safety outcomes, the MARRS study establishes an important clinical dataset for Perfuze. As the company continues its U.S. market rollout, the findings may help shape the role of standalone aspiration in the evolving treatment landscape for patients with acute ischemic stroke caused by large vessel occlusion.
About Perfuze
Perfuze is a medical device company headquartered in Galway, Ireland, dedicated to developing next-generation catheter-based aspiration technology for acute ischemic stroke. Its growing neurovascular portfolio, including the Millipede88 Aspiration Catheter, Millipede70® Aspiration Catheter, and Zipline® Access Catheter family reflects a commitment to meaningful innovation at the frontier of stroke intervention. For more information, visit www.perfuze.com.