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EKOS™ Endovascular System

Clinical Evidence

The Data Behind the Smart Choice

Vascular Surgery / EKOS Endovascular System Overview / Clinical Evidence

A Reputation Built on Data

No pulmonary embolism interventional therapy has been studied as much as EKOS. The conclusion? EKOS is the only interventional device to treat PE that provides efficacy and safety data with long-term outcomes. The evidence is in the data—and in the 75,000+ patients who have benefitted from the procedure.

Reputation built on data - statistics icons.

A Decade Committed to Clinical Advancement

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  • 2014 ULTIMA – Level 1 PE Data Published
  • 2015 SEATTLE II – Pivotal PE Trial Published
  • 2018 OPTALYSE PE – Optimized PE Protocol; Long-Term Patient Outcomes
  • 2021 KNOCOUT PE Registry
    OPTALYSE Protocol Adoption & Additional Data Collection
  • 2024 HI-PEITHO – First & Largest Of Its Kind in PE

Safety or Efficacy is Not a Choice

You can have both with EKOS. See highlights and detailed data points behind some of the most critical studies in PE interventional treatment.
The ULTIMA Trial Results
Ultima Trial Results
The SEATTLE II Trial Results
Seattle II Trial Results
The OPTALYSE Trial Results
Optalyse Trial Results
Lungs in glowing light blue lines



The Future of EKOS Clinical Evidence

With the goal of gaining a deeper understanding of intervention for treating PE, Boston Scientific continues to invest in clinical studies. 


KNOCOUT

KNOCOUT has been designed to better understand the adoption of OPTALYSE protocols and provide additional safety, efficacy, and long-term data to the EKOS data set.

HI-PEITHO

HI-PEITHO represents the first-ever large-scale transatlantic, multi-center, prospective, randomized, controlled trial for an interventional device in PE. It has been designed to address critical gaps in clinical evidence by comparing the clinical benefit of intervention with EKOS vs anticoagulation alone.

 

Evidence Based Medicine, Now Backed by Updated Reimbursement.

Reimbursement increase

Weighted averages based on distribution of MS-DRGs from CMS’ Final IPPS FY 2021, MedPAR Vol 7b

Qualifying PE procedures increased +151% and qualifying vascular procedures increased +204%. To help your institution benefit from these new changes, we created an EKOS coding guide. It will show your billers and coders staff how to map the 58 new ICD-10-PCS codes to the appropriate DRGs.

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Indications, Safety and Warnings 

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