Objective:
Evaluate the safety and effectiveness of the FlowTriever System for treatment of PE in a real-world patient population.
Design
- Prospective, single-arm, multicenter registry: 500 patients, 50 sites
- Follow-up at 48-hours & 30-days
Primary Endpoint: MAE Composite through 48h
- Device-related mortality
- Major bleeding
- Intraprocedural device or procedure-related AEs, including clinical deterioration and device-related pulmonary vascular or cardiac injuries
Secondary Endpoints
- Impact on acute hemodynamics, procedural measures, 48h/30d all-cause mortality, and longer-term patient outcomes
FLASH Highlights
230 Patients Enrolled at 19 US Sites
93%
Intermediate-Risk
96.3%
Positive RVD Biomarkers
7%
High-Risk
69.7%
Concomitant DVT
1.6 + 0.5
RV/LV Ratio
38.3%
Contraindicated for Lytics
On-Table Improvements
7 mmHg
Average drop in mean PA pressure
11.8%
Average improvement in cardiac index
22.7 bpm (20%)
Average drop in heart rate
Acute Safety (48-hrs)
0%
Mortality
0
Device-related pulmonary/cardiac injuries or procedural clinical deteriorations
1.3%
Major Adverse Events
30-Day Outcomes
0.4%
Mortality
6.7%
Readmission Rate
Significant Improvements in:
Dyspnea scores
RV/LV ratio
RV systolic pressure
RV systolic function
RV dilatation
FLASH Interim Results
Interim FLASH data demonstrates the ability of FlowTriever® to safely treat real-world PE patients leading to an immediate and sustained treatment effect including dramatic improvement in vitals, hemodynamics, and meaningful longer-term patient outcomes while obviating the need for thrombolytic drugs or consequent ICU.
Safety
Enrolled intermediate-risk and high-risk PE patients with 0 deaths at 48 hours and only one death (0.4%) at 30 days (non-PE related)
- MAE = 1.3% (0 device-related deaths, 3 major bleeds (non-ICH), and 0 intraprocedural device or procedure-related AEs)
- No Device-Related Major Adverse Events
Effectiveness
Patients experienced significant on-table improvements in hemodynamics and vitals, as well as significant improvement in cardiac function, vitals, and symptoms at 30 days
- Heart Rate, PA pressure, cardiac index, RVSWI, and TPVR all significantly improved at 48 hours compared to baseline
- Dyspnea, RV size, and RV function all significantly improved at 30 days compared to baseline
Length of Stay
Minimal hospital resource footprint following FlowTriever intervention
- Median ICU Stay post-procedure of 0 days
- Median hospital LOS of 3 days
- 30-day readmissions rate of 6.7%
