Inari Medical Announces 6-month FLASH Registry Interim Data Demonstrating Benefits of Lytic-Free Mechanical Thrombectomy in 500 Real-World PE Patients

Rhea-AI Summary

Inari Medical, Inc. (NASDAQ: NARI) announced promising interim results from the FlowTriever Outcomes Registry (FLASH) involving 500 pulmonary embolism patients. At 48 hours post-procedure, the major adverse event rate was 1.4% and mortality rate a low 0.2%, with no device-related complications. Significant improvements were observed in cardiac function and quality of life at 6 months. The study highlights FlowTriever as a leading therapy for intermediate and high-risk PE patients, demonstrating safety and effectiveness while minimizing hospital resource use.

Positive

• Major adverse event rate at 1.4% and mortality rate at 0.2%, indicating strong safety profile.
• Substantial improvements in hemodynamics and quality of life at 6 months post-treatment.
• FlowTriever system shows potential as frontline therapy for pulmonary embolism.

Negative

• None.

IRVINE, Calif., Oct. 28, 2021 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today announced positive acute and long-term interim results from the first 500 pulmonary embolism (“PE”) patients enrolled in the FlowTriever Outcomes Registry (“FLASH”). At 48 hours post procedure, the major adverse event rate and mortality rate were low, at 1.4% and 0.2%, respectively. None of the deaths or major adverse events were device related. Collectively, these PE patients experienced substantial on-table improvements in hemodynamics and symptoms, which translated to 6-month improvements in cardiac function, functional status, and quality of life measures. The outcomes were achieved while limiting utilization of hospital resources, with less than 4% of patients receiving adjunctive therapy and a median of 0 days in the ICU post procedure.

FLASH is a prospective, multicenter, single-arm registry evaluating real-world patient outcomes after treatment of PE with FlowTriever. The 500-patient interim results were presented at TCT 2021 on October 27^th via webcast by Principal Investigator, Catalin Toma, MD, an Interventional Cardiologist at University of Pittsburgh Medical Center (UPMC) in Pittsburgh, PA.

“These interim results reinforce the strong safety profile of the FlowTriever System in real-world PE patients, with substantial on-table clinical improvements and immediate symptom relief,” said Dr. Toma. “We believe these 6-month follow-up data suggest that removal of clot burden without the risks of lytics has potential positive long-term implications for PE patients, including strikingly low rates of hospital readmissions, dyspnea, CTED, and CTEPH. These data suggest that treatment with FlowTriever may fundamentally improve the natural course of the disease, and that is tremendously exciting.”

“FlowTriever is quickly becoming the frontline therapy for intermediate and high-risk PE. FLASH, already the largest prospective interventional data set in the field of PE, reinforces the excellent safety, functional improvement, and long-term outcomes of this approach,” said Thomas Tu, MD, Chief Medical Officer of Inari Medical. “We believe these data continue to raise the bar to which existing and new treatments will be held. We remain committed to venous thromboembolism patients and to advancing the treatment of this disease through clinical research and the continued development of purpose-built devices.”

About Inari Medical, Inc.
Inari Medical, Inc. is a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases. Inari has developed two minimally invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by FDA and CE marked for the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by FDA and CE marked for the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of pulmonary embolism and clot in transit in the right atrium.

Investor Contact:
Westwicke Partners
Caroline Corner
Phone +1-415-202-5678
caroline.corner@westwicke.com

FAQ

What were the interim results of Inari Medical's FlowTriever Outcomes Registry?

The interim results from the FlowTriever Outcomes Registry (FLASH) indicated a major adverse event rate of 1.4% and a mortality rate of 0.2% among 500 pulmonary embolism patients.

How does the FlowTriever System perform in treating pulmonary embolism?

The FlowTriever System has demonstrated a low major adverse event rate and significant improvements in cardiac function and quality of life for patients treated in the FLASH registry.

When were the results of the FLASH registry presented?

The results from the FLASH registry were presented on October 27, 2021, during the TCT 2021 conference.

What is the significance of the 6-month follow-up data for FlowTriever?

The 6-month follow-up data suggest that the FlowTriever System may improve the natural course of pulmonary embolism, with low rates of hospital readmissions and other complications.