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: ~1,000 patients, up to 70 sites
- Follow-up at 48-hours & 30-days, 6 months
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 Interim Results
500 Patients Enrolled at 26 US Sites
> 85%
Intermediate-high or high-risk
66.4%
Concomitant DVT
40%
Contraindicated for lytics
Acute Safety (48-hrs)
0.2%
All-cause mortality
0.0%
Device-related pulmonary/cardiac injuries or procedural clinical deteriorations
1.4%
Major adverse events
On-Table Improvements
7.4 mmHg
Average drop in mean PAP pressure
18%
Average improvement in cardiac index
11.5 bpm
Average drop in heart rate
Long-Term Outcomes
1.3%
All-cause mortality at 30 days
91%
Decrease in severe dyspnea at 6 months
Significant Improvements In:
RV/LV Function (mean 77 days)
QoL (6 months)
Transforming the Lives of Patients with Venous Disease
Interim FLASH data demonstrates the ability of FlowTriever® to treat real-world PE patients with unmatched safety, clinically meaningful, on-table improvements, and sustained long-term benefits without 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 = 1.4% (0 device-related deaths, 6 major bleeds (non-ICH), and 1 procedural-related AE (non device-related)
- No device-Related major adverse events
Effectiveness
Patients experienced immediate symptom improvement with significant changes in hemodynamics and vitals, as well as significant improvement in cardiac function and quality of life at 6 months
- Heart rate, PA pressure and cardiac index immediately improved compared to baseline
- Severe dyspnea, RV size, RV function and quality of life all significantly improved long-term
Resource Efficiencies
Minimal hospital resource footprint following FlowTriever intervention
- Median ICU Stay post-procedure of 0 days
- 30-day PE-related readmission rate of 1.3%
- 96.2% of patients treated without adjunctive therapies