Image: The EkoSonic IDDC and removable coaxial ultrasound transducer core (Photo courtesy of EKOS Corporation).
A new system allows controlled and selective infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism (PE).
The EkoSonic Endovascular System is an ultrasound-facilitated catheter-directed low-dose fibrinolysis device designed to gently accelerate the penetration of thrombolytic agents into a thrombus, providing high levels of lysis to minimize the risk of PE and intracranial hemorrhage. The system is intended for the treatment of patients with a 50% or more clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, as well as evidence of right heart dysfunction, based on a mean pulmonary artery pressure of 25 mmHg or higher, and/or echocardiographic evaluation.
The device consists of a multilumen intelligent drug delivery catheter (IDDC) with a removable coaxial ultrasound transducer core and a microsonic device (MSD). The acoustic energy conditions the clot by thinning fibrin and increasing porosity, creating a pressure gradient which transports the thrombolytic agent deep into the thrombus. As a result, there is no thrombus fracture or breakage, no damage to valves or the vascular wall, and no hemolysis.
An added benefit is that since red blood cells (RBCs) are not fractured during the procedure, there is no adenosine release and no additional compromise to renal function. The EkoSonic Endovascular System is a product of EKOS Corporation (Bothell, WA, USA), and has been approved by the US Food and Drug Administration (FDA).
“The EKOS clinical data established that patients stricken with a life-threatening pulmonary embolism can be successfully and safely treated with the EkoSonic system,” said Prof. Samuel Goldhaber, MD, director of the Thrombosis Research Group at Brigham and Woman’s Hospital (Boston, MA, USA). “This is the first FDA cleared treatment option for PE since the approval of the drug tissue plasminogen activator [tPA], in 1990.”
“Interventional radiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use our system to provide faster, safer and more complete dissolution of thrombus,” said Matt Stupfel, General Manager of EKOS. “We are proud to have completed the world’s only randomized controlled trial and the largest prospective single-arm trial 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.”