BTG trial shows safety and efficacy of pulmonary embolism device

Healthcare company BTG said on Monday that its EKOS combination therapy device for pulmonary embolism is effective over a much shorter period and at safer thrombolytic doses far below the current standard, which will allow for scheduling flexibility and efficiencies in clinician time and drug costs.

The group’s OPTALYSE PE trial, which was carried out on 101 patients with acute proximal pulmonary embolism, saw patients achieve a significant reduction in the main indicator of right heart strain from PE by approximately 23% to 26%. The trial also showed a very low bleeding rate of 3% compared to 10% in the previous SEATTLE II study where patients were treated with 24mg for 12 or 24 hours.

"OPTALYSE PE sets a new standard for PE treatment," said study author Dr. Victor Tapson of the Pulmonary and Critical Care Division at Cedars-Sinai Medical Center in Los Angeles.

"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."

Pulmonary embolism is a condition that occurs when a piece of a blood clot breaks off from a clot in the legs and travels through the vasculature, getting trapped in the pulmonary arteries. When this happens the clot keeps blood from getting to some areas of the lungs to receive oxygen, sometimes leading to excessive strain on the right side of the heart, ultimately causing heart failure and/or cardiovascular collapse.

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