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TCT: Inari Medical Announces Results From the Fully Enrolled 800-Patient US Cohort of the FlowTriever FLASH Registry
IRVINE, Calif., Sept. 19, 2022 -- Inari Medical, Inc. 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 18th 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 3rd 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.
