The company designed its FlowTriever for device retrieval and aspiration. The system treats pulmonary embolism (PE). FlowTriever non-surgically removes clots from peripheral blood vessels. Its uses include treatment for PE and clots in transit in the right atrium. It received FDA 510(k) clearance in 2018.
Dr. Catalin Toma of the University of Pittsburgh Medical Center (UPMC) presented data at the 2022 TCT (Transcatheter Cardiovascular Therapeutics) conference. Results from the 800-patient FLASH registry were simultaneously published in EuroIntervention.
The registry evaluates real-world patient outcomes after treatment of PE with FlowTriever. It has a primary endpoint of major adverse events comprising device-related mortality or major bleeding within 48 hours and intraprocedural device or procedure-related acute events. That rate came in low at 1.8%, Inari said in a news release.
Patients experienced immediate hemodynamic and symptom improvement with a modest hospital resource burden. This is demonstrated by a minimal need for adjunctive therapy and a median post-procedure ICU stay of zero days. All-cause mortality registered low at 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.”
‘A new era’
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, said the registry represents “the largest study to date in the interventional approach to PE.”
He added that it 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 Dr. Thomas Tu, CMO 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.”