Inari Medical Submits IPO Prospectus Highlighting Superiority of FlowTriever Mechanical Thrombectomy Over Catheter-Directed Thrombolysis in PEERLESS Randomized Trial

Nov 01, 2024 22:15 CST Updated 22:15

Inari Medical

Cardiovascular Disease Treatment Device Developer

Inari MedicalLarge-Bore Mechanical Thrombectomy Presented at TCT2024 ConferenceFlowTriever) with the randomized controlled trial data of catheter-directed thrombolysis (PEERLESS). The study data was also published in "Circulation》Above.

PEERLESS isA prospective, randomized controlled trial enrolled 550 patients across 57 centers in the United States, Germany, and Switzerland. The experimental group (FlowTriever, n=274) and the control group (CDT, n=276). Assessments were conducted at 24 hours, discharge (orPostoperative7 days) and 30-day postoperative follow-up.

Specific Research Data

Compared with the control group, PEERLESS achieved its primary composite endpoint (odds ratio 5.01, p<0.001) due to a significant reduction in clinical deterioration or treatment escalation, fewer ICU admissions, and shorter ICU stays with FlowTriever compared to CDT. Patients also experienced faster clinical and hemodynamic recovery, shorter hospital stays, and lower 30-day readmission rates.
Reduce Deterioration/Rescue: AndControl GroupPhaseCompare,Experimental GroupClinical deterioration and/or treatment escalation to rescue was reduced by 3 times.
Faster Recovery: The trial group showed greater improvement in clinical symptoms and hemodynamics within 24 hours, with fewer 30-day readmissions.
Reduce Hospital Resource Utilization:Experimental GroupThe ICU admission rate, ICU length of stay (LOS), and hospital LOS were significantly reduced.
Safety Analysis Conclusion: In the trial group, no patients died within discharge or 7 days, no deterioration related to cardiac arrest, high-degree atrioventricular block, or respiratory failure occurred, and the all-cause mortality rate was low at 0.4% during the 30-day follow-up.

PI Evaluation

"These results are crucial for guiding optimal PE treatment decisions, providing strong evidence that FlowTriever can reduce clinical deterioration and the need for repeat interventions through more effective early thrombus removal. As the only randomized trial evaluating mechanical thrombectomy for PE, PEERLESS now allows us to confidently say,FlowTriever treatment is safe, effective, and superior to CDT.。”

---Wissam Jaber Emory University School of Medicine

"These findings highlight the unique efficacy of FlowTriever in helping PE patients feel better faster. Notably, large-bore thrombectomy and blood reinfusion using FlowTriever have produced superior clinical outcomes while maintaining excellent safety. This indicates that we can facilitate faster recovery from pulmonary embolism, enable quicker patient discharge, and do so without introducing additional risks."

---Carin Gonsalves Thomas Jefferson University

Executive Evaluation

"PEERLESS is the first major randomized PE study in over a decade, reaffirming our commitment to research that changes practice and guidelines, and setting a new standard for clinically meaningful endpoints. The results of this study position FlowTriever as a primary intervention tool for intermediate-risk PE. PEERLESS is the first of a series of randomized controlled trials ongoing with Inari and others, ushering in a golden age of PE research. I would like to thank our dedicated steering committee and researchers for making this trial a reality and for their continued impact on patient care."

---Thomas Tu, Chief Medical Officer of Inari Medical

FlowTriever

FlowTrieverIt is the first mechanical thrombectomy system approved by the FDA for the treatment of pulmonary embolism, designed to rapidly remove blood clots and immediately improve symptoms in patients with acute pulmonary embolism.

FlowTrieverIncluding two core components: Triever Aspiration Catheter and FlowTriever Catheter.

The Trieve Aspiration Catheter is a large-lumen catheter with high traceability that can be used with large-bore syringes to quickly aspirate large amounts of thrombus while minimizing blood loss. It is available in three sizes: Triever16, Triever20, and Triever24.

The FlowTriever catheter is a catheter with three self-expanding nitinol mesh disks, available in four sizes: S (6-10 mm), M (11-14 mm), L (15-18 mm), and XL (19-25 mm). This catheter is designed to lyse thrombus and transport it to the Triever20.

Inari Medical

Inari MedicalIs an innovative medical device company focused on developing products that treat patients with venous diseases and transform their lives.