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EKOS™ Endovascular System

EKOS-PE

EKOS-PE Long Term and Quality of Life (QOL) Outcomes

The EKOS-PE study followed 137 patients for 3 years after they received EKOS treatment for massive and submassive PE. EKOS therapy was associated with significantly reduced the RV/LV diameter ratio, improved long-term RV function, and is associated with a low all-cause mortality rate and favorable perceived QoL post-procedure.


QOL Results at 37 Months (n=52)

Patients reported substantial improvements in respiratory symptoms, functional capacity, and social impact

61.5%

Felt their lungs were 'much better'

65.4%

Had no interference with normal activity

69.2%

Had no pain around the shoulder blade or chest


The EKOS-PE Study is one of the first to demonstrate long-term clinical outcomes after use of EKOS for PE. 


Safety


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Mean follow-up 26.5 ± 17.2 months

7.2% all-cause mortality


During patient hospital stay

0.7% in-hospital adverse event rate

 0.7% major bleeding (not ICH)
  0.7% ischemic stroke


At 30 days

5.1% all cause readmission rate

0.7% PE-related readmission



Efficacy

Mean follow-up 5.2 ± 7.8 months

RV/LV Ratio decrease: 

26.7%

Residual RV dysfunction

 

None79%
Mild8%
Moderate8%
Severe5%

Quality of life

Mean follow-up 37 ± 12 months

Substantial symptom improvement:

  • Most patients reported minimal or no pulmonary complaints post-procedure
  • Median scores for various lung-related pain or nagging sensations were at “never” levels
  • Mild chest pain and breathlessness were infrequent or absent for most

Enhanced functional capacity:

  • Routine home tasks, social activities, and moderate exertion showed “no limitation at all”
  • More strenuous activities (e.g., running) had mild-to-moderate limitations in a subset

 


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References

1. Sayfo, S. Evaluation of Long-Term Key Outcomes and Safety in Pulmonary Embolism: The EKOS-PE Study. Presented at the Cardiovascular Research Technologies Annual Conference. March 2025