FDA gives PE ultrasound device a green light

The FDA cleared an ultrasound-based infusion technology as a treatment for pulmonary embolism (PE). According to EKOS Corp., its EcoSonic system is the sole minimally invasive endovascular therapy on the market.

The EcoSonic Endovascular System allows low-dose thrombolytic treatment in patients with pulmonary embolism using a miniaturized ultrasound device in a catheter designed to deliver drugs such as thrombolytics. The device speeds up the dissolving of clots by accelerating therapeutics into thrombus, which allows physicians to reduce dose compared with standard care.

The device was originally designed to dissolve blood clots in the arms and legs. It received CE mark for the indication of PE in 2011.

EKOS, which is a BTG International group company, is based in Bothell, Wash.