PEERLESS Results Show Superiority of FlowTriever® Compared to Catheter-Directed Thrombolytics for Intermediate-Risk Pulmonary Embolism
Inari Medical announced positive results from the PEERLESS Randomized Controlled Trial comparing FlowTriever to catheter-directed thrombolytics (CDT) for intermediate-risk pulmonary embolism. The study, conducted across 57 centers with 550 patients, met its primary composite endpoint with a win ratio of 5.01 (p<0.001). FlowTriever demonstrated superiority with patients experiencing:
- 3X fewer clinical deteriorations and therapy escalations
- Fewer ICU admissions and shorter ICU stays
- Faster recovery of clinical symptoms
- Shorter hospital stays
- Fewer 30-day readmissions
The FlowTriever arm showed excellent safety with zero patient deaths at discharge or 7 days, no cardiac arrest-related deteriorations, and 0.4% all-cause mortality at 30-day follow-up.
Inari Medical ha annunciato risultati positivi dal PEERLESS Randomized Controlled Trial che confronta FlowTriever con trombolitici diretti al catetere (CDT) per embolia polmonare a rischio intermedio. Lo studio, condotto in 57 centri con 550 pazienti, ha raggiunto il suo endpoint primario composito con un rapporto di vittoria di 5,01 (p<0,001). FlowTriever ha dimostrato superiorità con i pazienti che hanno sperimentato:
- 3 volte meno deterioramenti clinici e escalation della terapia
- Meno ammissioni in terapia intensiva e permanenze più brevi in terapia intensiva
- Recupero più veloce dei sintomi clinici
- Permanenze ospedaliere più brevi
- Meno riammissioni a 30 giorni
Il gruppo FlowTriever ha mostrato un'ottima sicurezza con zero decessi dei pazienti alla dimissione o a 7 giorni, nessun deterioramento correlato all'arresto cardiaco e una mortalità per tutte le cause dello 0,4% al follow-up di 30 giorni.
Inari Medical anunció resultados positivos del Ensayo Controlado Aleatorizado PEERLESS que compara FlowTriever con trombolíticos dirigidos por catéter (CDT) para embolia pulmonar de riesgo intermedio. El estudio, realizado en 57 centros con 550 pacientes, alcanzó su objetivo primario compuesto con una relación de victoria de 5.01 (p<0.001). FlowTriever demostró superioridad con pacientes que experimentaron:
- 3 veces menos deterioros clínicos y escalaciones de terapia
- Menos ingresos en UCI y estancias más cortas en UCI
- Recuperación más rápida de los síntomas clínicos
- Estancias hospitalarias más cortas
- Menos reingresos a 30 días
El grupo de FlowTriever mostró una excelente seguridad con cero muertes de pacientes al alta o a los 7 días, sin deterioros relacionados con paro cardíaco y una mortalidad general del 0.4% en el seguimiento a 30 días.
이나리 메디컬은 중간 위험 폐색전증에 대한 FlowTriever와 카테터 지향 혈전 용해제(CDT)를 비교한 PEERLESS 무작위 대조 시험의 긍정적인 결과를 발표했습니다. 57개 센터에서 550명의 환자를 대상으로 진행된 이 연구는 승리 비율 5.01(p<0.001)로 주요 복합 평가 지표에 도달했습니다. FlowTriever는 우수성을 입증했습니다 환자들은 다음과 같은 경험을 했습니다:
- 임상 악화 및 치료 강화가 3배 감소
- ICU 입원이 적고 ICU 체류도 짧음
- 임상 증상 회복이 더 빠름
- 병원에 있는 기간이 짧음
- 30일 재입원이 적음
FlowTriever 그룹은 퇴원 시 또는 7일 후에 환자가 사망하지 않았으며, 심장마비와 관련된 악화가 없었고, 30일 추적 검사에서 모든 원인의 사망률이 0.4%로 나타났습니다.
Inari Medical a annoncé des résultats positifs de l'essai contrôlé randomisé PEERLESS comparant FlowTriever aux thrombolytiques dirigés par cathéter (CDT) pour l'embolie pulmonaire à risque intermédiaire. L'étude, menée dans 57 centres avec 550 patients, a atteint son critère d'évaluation composite principal avec un rapport de réussite de 5,01 (p<0,001). FlowTriever a démontré sa supériorité avec des patients connaissant:
- 3 fois moins de détériorations cliniques et d'augmentations de thérapie
- Moins d'admissions en soins intensifs et des séjours plus courts en soins intensifs
- Récupération plus rapide des symptômes cliniques
- Séjours hospitaliers plus courts
- Moins de réadmissions à 30 jours
Le groupe FlowTriever a montré une excellente sécurité avec zéro décès de patients à la sortie ou à 7 jours, aucune détérioration liée à un arrêt cardiaque et une mortalité toutes causes confondues de 0,4% à 30 jours de suivi.
Inari Medical hat positive Ergebnisse der PEERLESS randomisierten kontrollierten Studie veröffentlicht, die FlowTriever mit kathetergelenkten Thrombolytika (CDT) zur Behandlung von Embolien mittleren Risikos vergleicht. Die Studie, die an 57 Standorten mit 550 Patienten durchgeführt wurde, erreichte ihren primären zusammengesetzten Endpunkt mit einem Gewinnverhältnis von 5,01 (p<0,001). FlowTriever zeigte Überlegenheit mit Patienten, die Folgendes erlebten:
- 3-mal weniger klinische Verschlechterungen und Therapieerhöhungen
- Weniger Aufnahme in die Intensivstation und kürzere Aufenthalte auf der Intensivstation
- Schnellere Erholung von klinischen Symptomen
- Kürzere Krankenhausaufenthalte
- Weniger Wiederaufnahmen innerhalb von 30 Tagen
Die FlowTriever-Gruppe zeigte eine ausgezeichnete Sicherheit mit null Patiententoten bei Entlassung oder nach 7 Tagen, keine durch Herzstillstand verursachten Verschlechterungen und einer Gesamtsterblichkeit von 0,4% nach 30 Tagen Nachbeobachtung.
- Met primary composite endpoint with significant win ratio of 5.01 (p<0.001)
- Demonstrated 3X reduction in clinical deteriorations and therapy escalations
- Achieved faster patient recovery and improved clinical symptoms at 24 hours
- Reduced hospital resource utilization with shorter ICU and hospital stays
- Excellent safety profile with 0.4% 30-day mortality rate
- None.
Insights
The PEERLESS RCT results represent a significant breakthrough in pulmonary embolism (PE) treatment. The study's findings demonstrate FlowTriever's clear superiority over catheter-directed thrombolytics with a remarkable
Key clinical advantages include faster symptom recovery, reduced ICU admissions and shorter hospital stays. The safety profile is particularly impressive with
For Inari Medical, this positions FlowTriever as the potential new standard of care in interventional PE treatment. The simultaneous publication in Circulation adds significant credibility and should accelerate market adoption, potentially expanding FlowTriever's market share in the growing PE treatment space.
This landmark study significantly strengthens Inari's market position in the thrombectomy space. The compelling clinical data showing superior outcomes without the bleeding risks associated with thrombolytics creates a strong value proposition for both hospitals and payers. The reduction in ICU stays and hospital length of stay presents a clear cost-benefit argument for healthcare systems.
The publication in Circulation and presentation at TCT provide maximum visibility within the medical community. With PE affecting approximately 900,000 people annually in the US alone, the addressable market is substantial. The study's results should accelerate physician adoption and help secure favorable reimbursement policies, potentially driving significant revenue growth for Inari in the coming years.
Primary endpoint win driven by both hard clinical outcomes and hospital resource utilization
IRVINE, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced positive results from the prospective PEERLESS Randomized Controlled Trial (RCT) comparing FlowTriever to catheter-directed thrombolytics (CDT). The results were presented by Dr. Wissam Jaber, Professor of Medicine at Emory University School of Medicine and Co-Global Principal Investigator (PI), during the Late-Breaking Clinical Trial Session at the 2024 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in Washington, D.C. In recognition of the clinical relevance of the study, results were also simultaneously published in Circulation, the premier peer-reviewed journal of the American Heart Association (AHA).
PEERLESS met its primary composite endpoint (win ratio 5.01, p<0.001), driven by patients experiencing significantly fewer clinical deteriorations or therapy escalations, fewer ICU admissions, and shorter ICU lengths of stay with FlowTriever versus CDT. Patients also had faster recovery of clinical symptoms and hemodynamics, shorter hospital length of stay, and fewer 30-day readmissions.
“These results are crucial to guiding optimal PE treatment decisions, providing strong evidence that FlowTriever may reduce clinical deterioration and the need for reintervention through more effective early thrombus resolution,” said Dr. Jaber. “As the only randomized trial evaluating mechanical thrombectomy in PE, PEERLESS allows us to now confidently say that treatment with FlowTriever is safe, effective, and superior to CDT.”
The PEERLESS study was conducted across 57 centers worldwide, enrolling 550 intermediate-risk PE patients randomized to receive either FlowTriever thrombectomy or CDT. The primary RCT cohort excluded patients with absolute contraindications to thrombolytics and enrolled very few patients with relative contraindications. In addition to Dr. Jaber, study leadership includes Co-global PI Dr. Carin Gonsalves, Professor of Radiology and Co-Director of the Division of Interventional Radiology at Thomas Jefferson University, and European PI Prof. Stefan Stortecky, Associate Professor, Bern University Hospital, Inselspital, Switzerland.
“These findings underscore FlowTriever’s unique effectiveness in helping PE patients feel better more rapidly,” said Dr. Gonsalves. “What stands out is that large-bore thrombectomy and blood return with the FlowTriever system produced superior clinical outcomes and maintained an excellent safety profile. This shows we can facilitate faster recovery from PE, discharge patients sooner, and do so without additional risks.”
PEERLESS RCT Highlights:
- Reduced Deteriorations/Bailouts: FlowTriever patients had 3X fewer clinical deteriorations and/or therapy escalations to bailout compared to CDT.
- Faster Recovery: FlowTriever patients had greater improvement of clinical symptoms and hemodynamics at 24 hours, and fewer 30-day readmissions.
- Decreased Hospital Resource Use: FlowTriever patients had significantly less ICU admission, ICU length of stay (LOS), and hospital LOS.
- Conclusive FlowTriever Safety Profile: In the FlowTriever arm, there were 0 patient deaths at discharge or 7 days, 0 deteriorations related to cardiac arrest, high-grade AV block, or respiratory failure, and low
0.4% all-cause mortality at 30-day follow-up.
“PEERLESS, the first major randomized PE study in over a decade, reiterates our commitment to practice- and guideline-changing research and sets the new standard for clinically meaningful endpoints,” said Dr. Thomas Tu, Inari’s Chief Medical Officer. “The results of this study position FlowTriever as the primary interventional tool for intermediate-risk PE. PEERLESS is the first in a series of randomized controlled studies that Inari and others are bringing to light, kicking off the golden age of PE research. I wish to thank our dedicated steering committee and investigators for bringing this trial to reality and contributing to its ongoing impact on patient care.”
View the PEERLESS Results Summary Presentation: Link
Accepted for simultaneous publication in Circulation: Link
About Inari Medical, Inc.
Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underserved health needs. In addition to our purpose-built solutions, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous thromboembolism and four other targeted disease states. We are just getting started. Learn more at www.inarimedical.com and connect with us on LinkedIn, X (Twitter), and Instagram.
The FlowTriever system is 510(k)-Cleared by FDA and CE Mark approved for the treatment of pulmonary embolism and clot in transit in the right atrium.
Investor Contact:
Marissa Bych
Gilmartin Group LLC
IR@inarimedical.com
FAQ
What were the main results of the PEERLESS trial for Inari Medical (NARI)?
How many centers and patients participated in the PEERLESS trial for NARI stock?
What was the safety profile of FlowTriever in the 2024 PEERLESS trial?
Where were the PEERLESS trial results presented for Inari Medical (NARI)?
