Inari Medical Announces Results from the Fully Enrolled 800-patient US Cohort of the FlowTriever FLASH Registry

Rhea-AI Summary

Inari Medical (NASDAQ: NARI) announced positive results from the 800-patient FLASH registry, presented at the 2022 TCT conference. The study, evaluating the FlowTriever system in treating pulmonary embolism (PE), reported a low major adverse event rate of 1.8% and 30-day all-cause mortality of just 0.8%. The findings underscore FlowTriever's strong safety profile and clinical effectiveness, suggesting it may enhance PE treatment outcomes. Inari aims to continue developing high-quality evidence through ongoing studies like the FLAME registry and PEERLESS trial.

Positive

• FLASH registry demonstrates a major adverse event rate of only 1.8%.
• 30-day all-cause mortality rate is just 0.8%, significantly lower than the 10% reported in the PERT registry.
• Clinical improvements noted with minimal hospital resource burden and high patient satisfaction.
• Results support FlowTriever as a front-line therapy for pulmonary embolism.

Negative

• None.

IRVINE, Calif., Sept. 19, 2022 (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 and other diseases, announced positive outcomes of the fully enrolled 800-patient FLASH registry in pulmonary embolism (“PE”). The data was presented during a Late-Breaking Clinical Trial session at the 2022 TCT (Transcatheter Cardiovascular Therapeutics) conference on September 18^th by Principal Investigator (PI), Catalin Toma, MD, an Interventional Cardiologist at University of Pittsburgh Medical Center (UPMC). The data was also simultaneously published in EuroIntervention, the official journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

FLASH is a prospective, multicenter, single-arm registry evaluating real-world patient outcomes after treatment of PE with FlowTriever. The primary endpoint, major adverse events (MAEs) comprising device-related mortality or major bleeding within 48 hours and intraprocedural device or procedure-related acute events, was low at 1.8%. Patients experienced immediate hemodynamic and symptom improvement with modest hospital resource burden, demonstrated by minimal need for adjunctive therapy and a median post procedure ICU stay of 0 days. All-cause mortality was only 0.8% at 30 days.

“These results, in a large patient population spanning 50 sites, further reinforce the strong safety profile of the FlowTriever System, while achieving substantial on-table clinical improvements and immediate symptom relief,” said Dr. Toma. “A 30-day all-cause mortality rate less than 1% in intermediate- and high-risk PE patients is exceptional, especially in lieu of the 10% mortality reported in the PERT registry. These data suggest that safe, rapid thrombus extraction with FlowTriever may significantly improve the natural course of the disease.”

“The FLASH registry data presented in the Late-Breaking Clinical Trials session at TCT represents the largest study to date in the interventional approach to PE, which is the 3^rd leading cause of cardiovascular death,” said Dr. Sahil Parikh, Director of Endovascular Services at Columbia University Irving Medical Center and Associate Professor of Medicine at the Columbia University College of Physicians and Surgeons. “The study demonstrates exceptional safety and acute and midterm results with dramatic improvement in clinical symptoms with efficient single session procedure. These data, along with ongoing RCT, will hopefully herald a new era in the interventional treatment of PE.”

“We believe these results, in addition to the more than 35,000 patients treated commercially, reinforce FlowTriever as a front-line therapy for PE,” said Thomas Tu, MD, Chief Medical Officer of Inari Medical. “We remain committed to developing high-quality evidence that advances the treatment of this disease, including the currently enrolling FLAME registry and PEERLESS randomized controlled trial.”

About Inari Medical, Inc.

Inari Medical, Inc. is a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases. Our current product offering consists of 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 results of the FLASH registry for Inari Medical (NARI)?

The FLASH registry reported a 1.8% major adverse event rate and a 0.8% 30-day all-cause mortality rate for the FlowTriever system in treating pulmonary embolism.

When were the FLASH registry results presented?

The results of the FLASH registry were presented on September 18, 2022, at the TCT conference.

What is the significance of the FLASH registry results for NARI?

The FLASH registry results reinforce the safety and clinical efficacy of FlowTriever, supporting its use as a front-line therapy for pulmonary embolism.

How many patients were enrolled in the FLASH registry?

The FLASH registry included 800 patients treated with the FlowTriever system.

What kind of company is Inari Medical (NARI)?

Inari Medical is a medical device company focused on treating venous diseases, notably through its FlowTriever and ClotTriever systems.