November 13, 2020
Interim 30-Day Data Presented From FLASH Registry of Inari’s FlowTriever System
November 13, 2020—Inari Medical, Inc. announced that 30-day follow-up results of the first patients enrolled in the FLASH study were presented by National Principal Investigator Catalin Toma, MD, at the American Heart Association (AHA) Scientific Sessions 2020 held as a virtual meeting on November 13-17.
FLASH is a 500-patient prospective, multicenter, single-arm registry evaluating outcomes in intermediate- and high-risk, real-world patients after treatment of pulmonary embolism (PE) with the company’s catheter-based FlowTriever mechanical thrombectomy device.
The interim data is from the first 230 patients treated at 19 sites in the United States.
According to Inari, one death (0.4%) was reported at 30 days. By contrast, the national PERT Consortium Quality Database showed 30-day mortality rates of 25.9% and 6.1% for high- and intermediate-risk PE patients.
Additionally, the FLASH registry showed a readmission rate of 6.7%, compared to an approximately 25% readmission rate in the PERT database. Efficacy data showed normalization or near normalization in hemodynamic variables, including pulmonary artery pressure, right to left ventricular ratio, and heart rate, as well as dyspnea metrics.
In October, Dr. Toma presented acute data from the same patient set at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.
The findings presented at TCT showed that the primary endpoint of freedom from major adverse events at 48 hours was met by 227 (98.7%) of the first 230 patients enrolled in the study. Those data also showed clinically and statistically significant improvement in hemodynamic parameters while the patient was still on the table. Postprocedure median ICU stay was 0 days.
The FLASH data presented at AHA extend the follow-up period to 30 days and demonstrate the durability of these acute results with continued improvement in outcomes over time, noted the company.
“FLASH has shown us that PE patients experience symptom relief and improved cardiac function immediately upon removal of significant clot burden,” commented Dr. Toma in the company’s announcement. “These outcomes continue to improve over time. In fact, for a high percentage of these patients, measurements for dyspnea, right heart strain, pulmonary artery pressure, and heart rate actually normalized after FlowTriever thrombectomy.”
Dr. Toma concluded, “We believe this suggests that removal of large clot burden with the FlowTriever system not only has an important impact acutely but might have an important positive effect on long-term implications of PE, like chronic thromboembolic pulmonary disease and chronic thromboembolic pulmonary hypertension.”