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EKOS™ Endovascular System

A first-line pulmonary embolism intervention. Proven to yield safe and effective results, EKOS is low risk and reliable. Because of EKOS’ small size, it allows further reach into smaller distal pulmonary vessels. The EKOS+ catheter builds on the legacy of EKOS, and provides more ultrasound power to resolve clot burden more quickly and completely.

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EKOS features & benefits 

EKOS is a safe, repeatable and reliable treatment that dissolves thrombus quickly with low lytic, low blood loss and low trauma – resulting in proven long-term outcomes. EKOS leverages the power of targeted ultrasonic waves to thin and separate fibrin strands and accelerates lytic dispersion deeper into the clot. The addition of the new EKOS+ catheter offers the same procedure & clinical workflow, with 50% more ultrasound power.1

Ultrasonic core technology

  • Minimally invasive, 15-minute EKOS procedure that is quick to perform
  • Lytic agent: as low as 8 mg tPA used2
  • Ultrasonic waves accelerate clot dissolution by unwinding and thinning fibrin strands to expose more drug receptor sites; acoustic streaming drives the drug deeper into the clot for safe dissolution
EKOS Control Unit 4.0.
Circle target icon.

Target thrombus safety

Blue outlined circle with various size dots icon.

Superior clot dissolution

Blue outlined circle with small dots and lines icon.

Acoustic pulse acceleration

EKOS+ Endovascular System: How it works



  1.  Bench data on File
  2. Tapson V et al. A randomized trial of the optimum duration of acoustic pulse thrombolysis procedure in acute intermediate-risk pulmonary embolism. JACC: Cardiovascular Interventions 2018; 11(14):1401-1410.

The EKOS ultrasound difference

EKOS is a minimally invasive system for dissolving thrombus. The ultrasonic core generates an acoustic field which greatly accelerates lytic dispersion by driving the drug deeper into the clot and unwinding the fibrin to expose plasminogen receptor sites.

EKOS systems for dissolving thrombus.

EKOS' targeted ultrasound waves accelerate thrombus dissolution by unwinding the fibrin matrix.1

Fibrin before EKOS ultrasound.

Before EKOS ultrasound

Fibrin after EKOS ultrasound.

After EKOS ultrasound



1. Braaten JV et al. Ultrasound reversibly disaggregates fibrin fibers.Thromb Haemost 1997;78:1063-8

Technical information

EKOS™ Endovascular System

  • 5.4 F infusion catheter for all EKOS products
  • 106 cm infusion catheter (.035” guidewire compatible) with one ultrasonic core matched to corresponding length
    • Treatment zones from 6 cm – 50 cm
  • 135 cm infusion catheter (.035” guidewire compatible) with one ultrasonic core matched to corresponding length
    • Treatment zones from 12 cm – 50 cm

EKOS™+ Endovascular System

  • 7.8 F infusion catheter for all EKOS+ products
  • 106 cm infusion catheter (0.035" guidewire compatible) with one ultrasonic core matched to corresponding length
    • Treatment zones from 8 cm – 20 cm
  • 135 cm infusion catheter (0.035" guidewire compatible) with one ultrasonic core matched to corresponding length
    • Treatment zones from 8 cm – 20 cm

  See Ordering Information for additional details


Now available: EKOS Control Unit 4.0

EKOS cu 4.0 and cart

 

EKOS Control Unit 4.0 (EKOS CU4.0) offers new functionality and workflow-based intelligence for EKOS devices both at the procedure table and in the ICU. It is a critical part of the EKOS system that continues to break new ground in the treatment of PE.

EKOS CU4.0 is the result of extensive collaboration with our clinician partners to improve every step of the EKOS therapy experience to support your team's ability to perform at its highest level making workflow easier and more integrated from the lab to ICU. New features of the EKOS CU4.0 include an interactive color touchscreen, a built-in battery and separate ports for managing two EKOS devices simultaneously, simplifying bilateral treatment of pulmonary embolism (PE).

EKOS control Unit 4.0 console overview

Bilateral PE treatment, simplified

  • Manages two EKOS Devices at once with A/B channels and easy-to-read screens for bilateral PE Acoustic Pulse Thrombolysis treatment.
  • Small, lightweight and portable allowing easy integration into hospital workflow.
  • Speeds set-up time with easy to follow on-screen step-by-step prompts.
  • Intelligent on-screen troubleshooting tells you where the issue is and how to correct it.
  • Built in battery makes it easier to transport patients from the lab with zero interruption in therapy. 

Compatibility

  • EKOS CU4.0 will run all EKOS devices currently run by the PT-3B Control Unit.
  • EKOS+ is only compatible with the Control Unit 4.0.

Ordering information

EKOS™ Endovascular System

5.4 F infusion catheter for all EKOS products.

106 cm infusion catheter (0.035" guidewire compatible) with one ultrasonic core matched to corresponding length.

UPN/Order code

GTIN

Catheter length (cm)

Treatment zone (cm)

500-55106

858593006028

106

6

500-55112

858593006134

106

12

500-55118

858593006141

106

18

500-55124

858593006158

106

24

500-55130

858593006165

106

30

500-55140

858593006172

106

40

500-55150

858593006189

106

50

135 cm infusion catheter (0.035" guidewire compatible) with one ultrasonic core matched to corresponding length.

UPN/Order code

GTIN

Catheter length (cm)

Treatment zone (cm)

500-56112

858593006264

135

12

500-56130

858593006295

135

30

500-56140

858593006301

135

40

500-56150

858593006318

135

50

EKOS™+ Endovascular System

7.8 F infusion catheter for all EKOS+ products.

106 cm infusion catheter (0.035" guidewire compatible) with one ultrasonic core matched to corresponding length.

UPN/Order code

GTIN

Catheter length (cm)

Treatment zone (cm)

H74939605106080

191506015459

106

8

H74939605106120

191506015466

106

12

H74939605106160

191506015473

106

16

H74939605106200

191506015480

106

20

135 cm infusion catheter (0.035" guidewire compatible) with one ultrasonic core matched to corresponding length.

UPN/Order code

GTIN

Catheter length (cm)

Treatment zone (cm)

H74939605135080

191506015497

135

8

H74939605135120

191506015503

135

12

H74939605135160

191506015510

135

16

H74939605135200

191506015527

135

20

EKOS™ Endovascular System Control Unit 4.0

UPN / Order code

GTIN

Equipment class

Power requirements

Size

Weight

600-40500

858593006462

Class II (product code KRA)

250VAC, 50/60Hz

26.9 x 22.7 x 11.4 cm

12.5 lb

EKOS clinical trials and highlights

EKOS offers a safe and effective treatment to dissolve thrombus in the body's vascular system. With Level 1, Long-Term, and Quality of Life data, EKOS is the most studied device in the space.

EKOS uses targeted ultrasonic waves in combination with clot-dissolving drugs in the treatment of PE. Clinical evidence shows the therapy's ability to effectively target an entire clot without an increase in bleeding complications.

Efficacy

EKOS has been shown to yield safe and effective results for acute, massive and submassive PE.

  • Reduces RV/LV ratio by more than 23% on average in as little as 2 hours
  • Reduces PA pressures by 28% (at 48 hours)
  • Up to 88-92% less thrombolytic dose than standard systemic treatment 1,2
  • Minimized risk of bleeding
StudyRV/LV reduction
ULTIMA23% (24 hours)
SEATTLE II25% (48 hours)
OPTALYSE23-26% (48 hours)

Safety

EKOS has been shown to have a low risk of bleeding and ICH.

  • Low major bleeding rate across studies (1.44%)
  • ICH rate of 0.4% across major studies, two with 0 instances of ICH
StudySafetyTotal dose
ULTIMA0% (Major bleed) | 0 (ICH)20mg
SEATTLE II0.67% (Severe bleed) | 0 (ICH) 24mg
OPTALYSE3% (Major bleed) | 1 (ICH)4/8mg-12/24mg

Study  nameStudy  description (Level)Status
 Venous thromboembolism: Deep venous thrombosis* 
CAVAA randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis, combined with standard anticoagulant therapy, with standard anticoagulant therapy alone, for acute primary iliofemoral deep vein thrombosis (Level 1)Enrolling
ACCESS PTSAccelerated thrombolysis for post-thrombotic syndrome using the EKOS system (Level 2) Download the data summary
Completed
   
 Venous thromboembolism: Pulmonary embolism 
ULTIMAUltrasound accelerated thrombolysIs of pulmonary embolism (Level 1)Completed
SEATTLE IIA prospective, single-arm, multi-center trial of EKOS for acute pulmonary embolism (Level 2)Completed
OPTALYSE PEStudy of the optimum duration of acoustic pulse thrombolysis procedure in the treatment of acute submassive pulmonary embolism (Level 2)Completed
KNOCOUT PEInternational EKOS registry of the treatment and clinical outcomes of patients with pulmonary embolismCompleted
   
 Arterial occlusion* 
DUETDutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thrombo-emoblic infra-inguinalCompleted
DUET IIDutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thrombo-emoblic infra-inguinalStart-up

*Safety and effectiveness have not been established in this patient population

1.       Tapson V et al. A randomized trial of the optimum duration of acoustic pulse thrombolysis procedure in acute intermediate-risk pulmonary embolism. JACC:Cardiovascular Interventions 2018; 11(14):1401-1410.

2.        Konstantinides S, Geibel A, Heusel G, et al. Heparin plus alteplase compared with heparin alone in patients with submassive pulmonary embolism. N Engl J Med.2002;347:1143–1150.

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