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%