EKOS, a BTG International group company, has received approval from the US Food and Drug Administration (FDA) for its EkoSonic endovascular system to treat pulmonary embolism.
The FDA has approved the EkoSonic endovascular system for the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
The company claims that the EKOS ultrasonic devices have been developed to gently accelerate the penetration of thrombolytic agents into thrombus, providing high levels of lysis.
EKOS general manager Matt Stupfel said that the EKOS clinical data established that patients stricken with a life-threatening pulmonary embolism can be successfully and safely treated with the EkoSonic system.
"This is the first FDA cleared treatment option for PE since the approval of the drug, tPA, in 1990."
"We are proud to have completed the randomized controlled trial (ULTIMA) and the largest prospective single-arm trial (SEATTLE II) on the safety and effectiveness of EKOS therapy in the treatment of PE. The positive outcomes of those trials, combined with our expanded indication will allow a better standard of care for thousands of patients who suffer from PE."
Outcomes of the ULTIMA trial were published American Heart Association’s Journal, Circulation in January 2014.
This trial showed the EKOS treatment was clinically superior to anticoagulation with heparin alone in reversing right ventricular dilation at 24 hours, without an increase in bleeding complications.
Outcomes of the single arm, multi center SEATTLE II trial were released at American College of Cardiology 2014.
This trial showed that ultrasound-facilitated catheter-directed low-dose fibrinolysis for acute pulmonary embolism minimizes the risk of intracranial hemorrhage, improves RV function, and decreases pulmonary hypertension.