BTG plc, the global healthcare company, highlighted the presentation of OPTALYSE PE trial results at the Society for Cardiovascular Angiography and Interventions in San Diego, California. The findings further confirm that bilateral pulmonary embolism treated in as little as 2 hours with significantly less tissue plasminogen activator (tPA) than used in previous studies- as low as 8mg total - show significant improvement in RV/LV ratio over both the short and long term and with a very low mortality rate of 2% and an equally low recurrent PE rate of 2%.
"EKOS is the only endovascular device cleared by the FDA for the treatment of pulmonary embolism," said Dr. Gregory Piazza, Cardiologist for Brigham and Women's Hospital and professor at Harvard Medical School. "We are constantly in need of more data to help drive decision-making in PE. So far the most data that exists in PE is associated with EKOS therapy and the data provided in the OPTALYSE study advances the science of PE treatment even further."
The one-year data from OPTALYSE PE demonstrates improved quality of life of over 30% using two unique measurement systems. "Prior to this data being published, comparable studies put one-year mortality at 8-10% when treating with systemic thrombolysis or anti-coagulation," explained Lynn Allen, Vice President of Clinical Affairs for BTG Vascular. "This one-year data further demonstrates the safety - with only 3% bleeding, proven quality and effectiveness of the OPTALYSE PE treatment regimens and now we can also demonstrate quality of life improvement for these patients."
A separate registry study, KNOCOUT PE is intended to measure how institutions are adopting OPTALYSE PE and this new standard of care. The study is expected to include as many as 100 centers globally and is currently enrolling.