LAS VEGAS and MARLBOROUGH, Mass., Oct. 5, 2021 /PRNewswire/ -- Today, Boston
Scientific (NYSE: BSX) announced positive results for the EkoSonic™
Endovascular System (EKOS system) during a late-breaking clinical
trial presentation at the Vascular InterVentional Advances (VIVA)
meeting in Las Vegas. Data from
the KNOCOUT PE registry – established to measure institutional
adoption of a lower dose and lower-duration thrombolysis protocol
for the EKOS system – confirmed the safety and efficacy of the
EKOS system for the treatment of patients with intermediate-high
and high-risk pulmonary embolism (PE).
"PE remains a life-threatening and complex disease, but
these results provide an opportunity to advance patient care by
showcasing evidence that proves a lower drug dose and shorter
infusion duration of a thrombolytic agent may result in enhanced
safety and efficacy," said Keith M.
Sterling, M.D., FSIR, Inova Alexandria Hospital,
Alexandria, VA, study principal
investigator.i "The findings in this registry
analysis are very reassuring to physicians making critical
evidence-based decisions for their patients in what are oftentimes
emergent treatment situations."
The international registry of 489 patients across 83 centers
included data from patients treated with the EKOS system who were
provided a lower drug dose and shorter infusion duration of a
thrombolytic agent than administered in previous studies,
reflecting contemporary clinical practice. In the data, there were
no intracerebral hemorrhagic (ICH) events, or brain bleeding
events, with a low major bleedingii rate of 2.5%,
compared to the rate previously observed with systemic thrombolysis
treatment.iii Results also demonstrated a 23%
post-procedure reduction in the main indicator of heart strain from
PE, measured as right ventricular to left ventricular diameter
ratio (RV/LV).
"As the largest prospective body of evidence in the
interventional PE space to date, the KNOCOUT PE registry provides
an accurate modern representation of patients with PE treated with
the EKOS system every day," said Michael R.
Jaff, D.O., chief medical officer and vice president
clinical affairs, technology and innovation, Peripheral
Interventions, Boston Scientific. "The strong safety and
efficacy findings exhibited in this registry add to the existing
clinical evidence supporting the EKOS system as a treatment option
that physicians can trust, as it is already the most studied
interventional device in the PE space."
The ultrasound technology used by the EKOS system accelerates
thrombolysis – the breakdown of the clot – minimizing the time it
takes to treat a patient and lowering the necessary thrombolytic
dose, which can result in optimized outcomes and a lower risk of
bleeding.
To learn more about the EKOS system, please visit
www.bostonscientific.com/ekos.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the world. As
a global medical technology leader for more than 40 years, we
advance science for life by providing a broad range of high
performance solutions that address unmet patient needs and reduce
the cost of healthcare. For more information, visit and connect on
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CONTACTS:
Karin Dalsin
Media Relations
(763) 494-1914
Karin.Dalsin@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
i Dr. Keith
Sterling is a paid consultant for Boston Scientific
Corporation. He has not been compensated for his quote within this
press release.
ii Major bleeding as defined by International
Society on Thrombosis & Haemostasis (ISTH).
iii Meyer G, et al. Fibrinolysis for patients with
intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr
10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.
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SOURCE Boston Scientific Corporation