Boston Scientific has begun subject enrolment in the HI-PEITHO clinical trial to analyse the use of its EkoSonic Endovascular System (EKOS), along with anticoagulation for the treatment of acute, intermediate-high-risk pulmonary embolism (PE).
PE is a blood clot that leads to one or more pulmonary artery blockages in the lungs and is a major cause of in-hospital deaths in the US.
Leveraging ultrasound energy along with a thrombolytic drug, the EKOS system can dissolve blood clots and normalise blood flow in PE and peripheral arterial occlusion cases.
The company noted that the ultrasound technology used in the endovascular system boosts the breakdown of blood clots or thrombolysis, thereby reducing the time needed to treat a patient.
Furthermore, the technology can reduce the required thrombolytic dose to offer better outcomes and reduce bleeding risk.
The randomised, controlled HI-PEITHO trial is being conducted in partnership with the Pulmonary Embolism Response Team Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz.
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The trial will enrol up to 544 subjects with acute, intermediate-high-risk PE at nearly 65 sites in the US and Europe.
It will compare the use of the EKOS system plus anticoagulation to anticoagulation alone in substantially decreasing adverse events in less than seven days after randomisation.
The participants will also be followed up for a year, Boston Scientific noted.
PE-linked mortality, cardiorespiratory decompensation or collapse and non-fatal symptomatic and objectively confirmed PE recurrence will be the trial’s composite primary goal.
Boston Scientific Peripheral Interventions clinical affairs, technology and innovation vice-president Michael Jaff said: “This first-of-its-kind international randomised controlled trial is intended to address current gaps in clinical guidelines and underscores our support of the highest level of research that may enable physicians to make data-based clinical decisions when choosing the best therapy for their patients with PE.”
Last month, Boston Scientific reported net sales of $3.07bn in the second quarter of 2021, a surge of 53.6% on a reported basis, compared with $2bn in the same period last year.