UK-based healthcare firm BTG has reported positive results from the OPTALYSE PE trial of EKOS therapy for the treatment of patients with pulmonary embolism (PE).
The EKOS system is designed to dissolve clots by delivering a combination of ultrasonic waves and clot-dissolving thrombolytic drugs.
The results indicated that EKOS effectively treats PE in a shorter time with safer thrombolytic doses, compared to the existing standard treatment.
The OPTALYSE PE trial evaluated therapeutic anticoagulation in combination with EKOS Acoustic Pulse Thrombolysis therapy in 101 acute proximal PE patients in 17 clinical sites.
The trial involved administration of 4mg per catheter of tissue plasminogen activator (tPA) over two hours or four hours, and 6mg or 12mg per catheter tPA over six hours.
BTG EKOS vice-president and general manager Matt Stupfel said: “EKOS is the only device cleared for the treatment of pulmonary embolism and with the OPTALYSE results, BTG is once again demonstrating our commitment to advancing the treatment of PE.
“Now patients can be treated in half the time and with half the dose or less, providing greater flexibility to clinicians, improved safety to patients, and potential cost savings to hospitals.”
The trial showed a significant 23-26% decrease in the main indicator of right heart strain from PE, which was measured as right ventricular to left ventricular diameter ratio (RV/LV), and a low bleeding rate of 3%.
The results were found to be consistent with previous EKOS trials such as multi-centre ULTIMA and SEATTLE II trials for acute massive and submassive pulmonary embolism.
In both the trials, the EKOS therapy was found to reduce RV/LV ratio by 23-25% at 48 hours.