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