Objective:

Evaluate the safety and effectiveness of the FlowTriever System for treatment of PE in a real-world patient population.

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Design

Prospective, single-arm, multicenter registry: 500 patients, 50 sites
Follow-up at 48-hours & 30-days

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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%

Now Enrolling