Design
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 (800 US + 200 Europe), 69 sites (50 US, 19 Europe)
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 and Clinical Outcomes
- Individual components of the primary endpoint
- Major access site complications
- All-cause mortality through 30 days
- Device-related serious adverse events through 30 days
- Hemodynamic improvements during the procedure
- Reduction in RV/LV ratio from baseline to 30 days and 6 months
- 6-month clinical outcomes, including echocardiographic RV function assessment, dyspnea score, 6-minute walk test distance, quality of life score, and CTEPH/CTED diagnoses
Key Eligibility Criteria
- Clinical signs and symptoms consistent with acute PE
- Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
- Intermediate- or high-risk PE
Duration of Patient Follow-up
- Patients are assessed at 48-hours, 30-days, and 6-months
Outcomes
Outcomes from the US Cohort of the FLASH Registry1, 2
for the treatment of pulmonary embolism with the FlowTriever system
<1.0%
All-cause mortality at 30-day follow-up1
N=734
N=734
Immediate
Hemodynamic
Improvement
800 patients enrolled
800 Patients Enrolled1
Intermediate-High or
High-Risk Patients
High-Risk Patients
Lytics
Contraindication
Contraindication
Concomitant
DVT
DVT
100mL median EBL
with the FlowSaver® Blood Return System
(n=79)
Immediate hemodynamic improvements1
P < 0.0001
P < 0.0001
* In patients with cardiac index <2.0 L/min/m2 at baseline
P < 0.0001
P < 0.0001
1.8%
Major Adverse Events (MAEs)
at 48 hours
Major Adverse Events (MAEs)
at 48 hours
0
Device Related Deaths
at 30-day follow-up
Device Related Deaths
at 30-day follow-up
<1.0%
All-Cause Mortality
at 30-day follow-up
All-Cause Mortality
at 30-day follow-up
Longer-term functional improvements2
*P < 0.0001 campared to baseline
*P < 0.0001 campared to baseline
*P < 0.0001 trend test over time
1.0% CTEPH
n=581
Read the Peer-Reviewed FLASH Results
Acute Outcomes from the FLASH Registry published in EuroIntervention
6-month Outcomes from the FLASH Registry published in JSCAI
Prevalence and Predictors of Cardiogenic Shock in Intermediate-Risk PE published in JACC:CI
Outcomes from the high-risk PE cohort of the FLASH Registry published in JSCAI
References
- Toma C et al. Acute Outcomes for the Full US Cohort of the FLASH Mechanical Thrombectomy Registry in Pulmonary Embolism. EuroIntervention 2023;18:1201-1212.
- Khandhar S et al. Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-risk Pulmonary Embolism: 6-Month FLASH Registry Results. JSCAI 2023;2(4):101000.
Indications for Use
The FlowTriever retrieval/aspiration system is indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels and (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever retrieval/aspiration system is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever catheters are intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever catheters. The Triever20 Curve is used coaxially within the Triever24 for (1) the non-surgical removal of emboli and thrombi from blood vessels and (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Triever20 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever20 Curve catheter is not indicated for use with FlowTriever catheters. Triever20 Curve is also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever catheters. Triever20 Curve must be used within the Triever24. The FlowSaver blood return system is used with Triever catheters for autologous blood transfusion. The Triever16 Curve is indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels and (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Triever16 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever16 Curve is not indicated for use with FlowTriever catheters. The Triever16 Curve is also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever catheters.
Review complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and contraindications prior to use of the product.
For all non-Stryker products, please refer to manufacturer Instructions for Use/Intended Purpose for complete indications for use, contraindications, warnings and precautions.
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.
All trademarks are property of their respective owners.
PRO-4506-USA-EN-v1