Researchers studied the 12-month outcomes of 101 patients who were treated over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard. Pulmonary embolism patients treated with BTG’s Ekos device and anti-coagulation drugs received therapy in as little as two hours with a tissue plasminogen activator dose as low as 8 mg, the company reported.
After one year, those patients sustained a 2% all-cause mortality rate, a recurrent pulmonary embolism rate of 2% and continued improvements in their quality of life, according to BTG.
The company also noted that the study’s participants experienced significant reductions in RV/LV diameter ratios which persisted through one year.
“The long-term follow-up results reinforce that a new interventional standard is being set for PE treatment,” principal investigator Victor Tapson said in prepared remarks. “The 2% one-year all-cause mortality rate observed in Optalyse PE is much lower than the ~8% rate seen in comparable anticoagulation studies. This is important for institutions that are adopting the new low-dose, shorter duration treatments explored in Optalyse PE.”
“Ekos is the only device cleared for the treatment of pulmonary embolism. This is the first time that long-term mortality and quality of life data has been reported for an interventional PE treatment, which continues to show our commitment to evidence-based innovation, predictable and cost-effective procedures, and strong safety profiles that improve patient outcomes and help make the most challenging cases easier,” Ekos VP & GM Matt Stupfel added.
“Within a short time we have seen the science advance so that patients today can be treated in as little as 2 hours and with total tPA doses as low as 8mg, providing greater flexibility to clinicians, improved safety to patients, and potential cost savings to hospitals at a time when healthcare systems need these efficiencies.”
BTG is also conducting a registry study, Knocout PE, to assess how hospitals are adopting and using the Ekos device to treat patients with pulmonary embolism.