BTG (LON:BTG) touted data today from the Optalyse PE trial showing that pulmonary embolism can be treated effectively with Ekos over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard.
The 101-patient trial randomized participants to receive therapeutic anticoagulation and Ekos acoustic pulse thrombolysis therapy at different doses for different lengths of time. The 1st group received 4 milligrams per catheter of tissue plasminogen activator over 2 hours, while the 2nd cohort received the same dose over 4 hours. The 3rd group was treated with 6 milligrams per catheter over 6 hours and the 4th group received 12 milligrams per catheter over 6 hours.
BTG’s Ekos system uses ultrasonic waves in combination with thrombolytic drugs to dissolve clots and restore heart function.
All 4 groups saw a significant reduction in the main indicator of right heart strain from pulmonary embolism by 23% to 26%, which is consistent with results from previous Ekos studies when treatment was applied for up to 24 hours, according to BTG.
The trial’s results also showed a low bleeding rate of 3% compared to 10% in a previous study where patients were treated with 24 milligrams for 12 or 24 hours.
“Optalyse PE sets a new standard for PE treatment,” study author Dr. Victor Tapson said in prepared remarks. “This trial builds on a growing body of clinical evidence, including the Ultima and Seattle II studies, showing a significant reduction in right-heart strain with shorter treatment durations and lower tPA doses. In addition to moving patients out of danger more quickly, hospitals can potentially save significant intensive care, drug and clinician time and cost due to increased safety and shorter treatment durations.”
“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,” Ekos VP and GM Matt Stupfel added. “Now patients can be treated in half the time and half the dose or less, providing greater flexibility to clinicians, improved safety to patients, and potential cost savings to hospitals.”