Latest news with #revascularization
Yahoo
16-07-2025
- Health
- Yahoo
Perfuze Presents Preliminary Results from MARRS Pivotal Trial at SNIS, Highlighting Millipede88 Performance in Acute Ischemic Stroke
Millipede88 Demonstrates High Revascularization and First Pass Effect Rates in 180 patient multicenter study GALWAY, Ireland, July 16, 2025--(BUSINESS WIRE)--Perfuze, a medical device company developing catheter technology for interventional stroke care, today announced positive preliminary results from its pivotal IDE clinical trial, MARRS (Millipede Aspiration for Revascularization in Stroke Study). These preliminary results were presented at the Society for NeuroInterventional Surgery (SNIS) Annual Meeting in Nashville, Tennessee, USA. The trial is evaluating the safety and effectiveness of the Millipede System for revascularization in acute ischemic stroke. Conducted across a network of leading stroke centers in the U.S. and Europe, the study included patients with occlusions in the ICA, M1, M2 and basilar, or vertebral arteries. The Millipede System includes the Millipede88 aspiration catheter, Perfuze's flagship Superbore aspiration catheter. The MARRS trial enrolled 180 evaluable subjects, with first pass direct aspiration being performed with the Millipede88 in 101 of these patients. The preliminary analysis shows a high rate of First Pass Effect (FPE), defined as complete or near-complete revascularization (mTICI 2c) following a single device pass. For patients treated with Millipede88, an FPE rate of 61% was observed across all target vessels in the Per Protocol (PP) population. Specifically, for M1 artery occlusions treated with Millipede88 in the PP population, an FPE rate of 77% was achieved. "The MARRS data are truly exceptional. Achieving 77% First Pass Effect for M1 occlusions in a pivotal study is a major advance for stroke care. The ability to reliably achieve rapid, complete reperfusion with a single aspiration pass is exactly what we need to improve efficacy. This technology is a powerful tool that simplifies thrombectomy and delivers outstanding performance," said Dr. Raul G. Nogueira, Principal Investigator of the MARRS Study and Professor of Neurology and Neurosurgery at the University of Pittsburgh School of Medicine. Across the 180 patients enrolled, delivery success of the Millipede System was 99%, and the median number of passes was 1. Preliminary safety analysis showed a symptomatic intracranial hemorrhage (sICH) rate of 1.7%. Perforation was reported at 0% and the rate of intracranial dissection was 1.1%, indicating a promising safety profile. "The MARRS study represents several years of work by the Perfuze team and our clinical partners," said Wayne Allen, CEO and Co-Founder of Perfuze. "We designed the Millipede88 to navigate seamlessly to the clot face, enabling a superbore catheter that improves the likelihood of achieving First Pass Effect. This early data reflects that intent, and we're encouraged by the physician feedback we've received to date." The MARRS trial completed enrollment earlier this year, executed ahead of schedule, reflecting strong engagement from stroke centers and interest in next-generation aspiration technology. These clinical results follow several successful milestones for Perfuze, including FDA 510(k) clearance for its Zipline™ Access Catheters and a €22 million funding round to support commercial expansion and operational scale-up. With these preliminary MARRS data, Perfuze is preparing for FDA submission. "This is a significant inflection point for the company," said Perfuze Chairperson, Hooman Hakami. "Preliminary MARRS results support the Millipede88 catheter's safety and effectiveness and underpin our vision to advance stroke intervention." About the Millipede System and MARRS Trial Millipede88 is a superbore aspiration catheter developed to support effective clot retrieval while maintaining navigability through challenging cerebrovascular anatomy. The MARRS trial is a prospective, multicenter, single-arm pivotal IDE study designed to evaluate the safety and effectiveness of the Millipede System in patients with large vessel occlusion stroke. Revascularization outcomes were adjudicated by an independent core laboratory. About Perfuze Perfuze is a privately held medical device company based in Galway, Ireland. The company is dedicated to developing advanced catheter technologies that simplify stroke procedures and aim to improve outcomes for patients suffering from acute ischemic stroke. For more information, visit Follow us on LinkedIn and X (formerly Twitter). Disclaimer: United States: CAUTION – Investigational device. Limited by Federal law to investigational use. Europe: Exclusively for use in a clinical investigation. These are preliminary results from an ongoing clinical investigation. The Clinical Study Report has not yet been approved or reviewed by regulatory authorities. Data may be subject to change and may not fully reflect the contents of the Clinical Study Report. View source version on Contacts Media Contact: Dr. Freskida GoniCommunications Consultant, Perfuzecomms@ +44 7473678178 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
30-06-2025
- Health
- Medscape
Revascularizing Vessels After STEMI Sees Durable Gains
For patients with ST-elevation myocardial infarction, complete revascularization of all vessels with stenosis appears to be a more effective long-term approach than targeting culprit arteries alone, according to a 10-year follow-up analysis of a Danish study. The new findings come from an analysis of patients in the DANAMI-3-PRIMULTI trial, one of several studies between 2017 and 2024 to show the value of complete revascularization, which is now recommended for patients with STEMI and multivessel disease by both US and European guidelines. But those recommendations are based on shorter-term outcomes. The question remained how long the benefits would last, said Thomas Engstrøm, MD, PhD, professor and senior consultant in the Department of Invasive Cardiology at The Heart Center, part of the University of Copenhagen, Copenhagen, Denmark. The latest data, published May 20 in the Journal of the American College of Cardiology , span the longest to date of a study of complete vs culprit-artery revascularization, he said. 'A short term of 1 or 3 years is good to see if a treatment works, but what's more important for patients is whether it is durable,' said Engstrøm, one of the authors of the original study as well as the follow-up analysis. 'Many of our patients are not that old; 10 years is not that long for a patient who has an acute myocardial infarction at 60 years of age.' The follow-up included all 627 patients in the original study, 313 of whom were randomized to culprit-artery revascularization and 314 to complete revascularization. Engstrøm said he and his colleagues manually reviewed hospital records for each patient to ensure they captured any events. Which Benefits Last? Complete revascularization was associated with better outcomes for a combination of death, recurring myocardial infarction, and recurring revascularization (hazard ratio, 0.76 compared with culprit-artery revascularization), according to the researchers. The ability of complete revascularization to prevent further revascularization accounted for the bulk of the difference, with a hazard ratio of 0.62. The results 'add further support for complete revascularization. It shows there's a persistent benefit, especially in regard to the need for repeat vascularization,' said William Fearon, MD, a professor of medicine at Stanford University, chief of interventional cardiology at Stanford University School of Medicine, Stanford, California, and the chief of the cardiology section at the VA Palo Alto Health Care System, Palo Alto, California. He was not involved in the trial. But other outcomes showed less benefit and were not statistically significant. All-cause mortality was almost the same in both groups (hazard ratio, 0.96). Cardiovascular mortality showed a 20% reduction with complete revascularization, but this difference was not statistically significant due to the low number of patients, Engstrøm said. Rates of recurrent myocardial infarction and definite stent thrombosis also were essentially the same in each group, the researchers found (odds ratio, 0.90 for both outcomes). Open Questions Other studies have shown benefit for mortality and myocardial infarction following complete revascularization. The COMPLETE trial in 2019 showed benefits for a combined outcome of cardiovascular death or myocardial infarction after 3 years (hazard ratio, 0.74), driven by a lower rate of recurrent myocardial infarction (hazard ratio, 0.68). At least two factors may explain the discrepancy in findings, Engstrøm said. The COMPLETE trial was much larger, with more than 4000 patients. 'It was more adequately powered to show effects,' Engstrøm said. 'I think the [DANAMI-3-PRIMULTI] study was relatively small relative to some others,' Fearon said. 'So, that limits the ability to look at specific endpoints that have a lower incidence.' 'What we're learning is that, for harder endpoints like [myocardial infarction], the benefit is really in more severe lesions.' DANAMI-3-PRIMULTI did not analyze patient outcomes by severity of lesions, whereas the COMPLETE trial did, he noted. In addition, revascularization was guided by different methods in the two trials. In DANAMI-3-PRIMULTI, complete revascularization was guided by fractional flow reserve (FFR) measurements, whereas the COMPLETE trial involved angiography-guided revascularization. 'The COMPLETE trial used a less stringent way of defining the lesions, by angiography. These lower-grade stenoses were not identified by FFR,' Engstrøm said. DANAMI-3-PRIMULTI did not measure FFR in patients in whom revascularization involved only the culprit artery, Fearon said. Another study reported in 2017, Compare-Acute, measured FFR in both complete and culprit-artery revascularization groups and found a lower FFR was associated with a higher rate of subsequent events, he said. The COMPLETE-2 trial currently underway is looking at whether FFR or angiography is a better way to measure blood flow in vessels, Engstrøm said. 'The COMPLETE trial showed us that angiography-guided complete revascularization is superior to culprit-artery revascularization,' said Fearon, who is on the steering committee for the COMPLETE-2 study. 'The other trials showed us that FFR-guided complete revascularization is superior, but we don't know whether FFR-guided complete revascularization is superior to angiography-guided complete revascularization.' Studies to date of complete vs culprit-vessel revascularization show 'a very uniform arrow that leads to complete revascularization,' Engstrøm said, 'but there are some corners that have not been shed light on.' Engstrøm is on the advisory board for Novo Nordisk and Abbott Medical. He has received speaker's fees from Abbott Medical, Boston Scientific, and Novo Nordisk. Fearon receives institutional research support from Abbott, CathWorks, and Medtronics. He has received consulting fees or honoraria from Shockwave Medical and from Edwards Lifesciences, and he has stock options in Heartflow.
