FDA Clears EkoSonic® Endovascular System for Pulmonary Embolism

EKOS Corporation has gained U.S. FDA clearance to market its 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 (PE).

Background

PE occurs in approximately 600,000 patients in the US, causing or contributing to an estimated 200,000 deaths each year. PE also causes or contributes to 15% of all hospital deaths. 

EKOS Corporation, a BTG International group company, pioneered the development and clinical application of ultrasound infusion technologies in medicine, introducing its first system for the treatment of vascular thrombosis in 2005. Today, interventional radiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use the EKOS EkoSonic® Endovascular System to provide faster, safer and more complete dissolution of thrombus.

The EKOS® ultrasonic devices are designed to gently accelerate the penetration of thrombolytic agents into thrombus, providing high levels of lysis. EKOS® is the only minimally invasive endovascular therapy on the market that has been FDA cleared for the treatment of PE.

Physician comments

Samuel Z. Goldhaber, MD, Professor of Medicine, Harvard Medical School and Director, Thrombosis Research Group, Brigham and Woman’s Hospital (Boston, MA), said, “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.”

Company comments

“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,” commented Matt Stupfel, General Manager of EKOS. “We are proud to have completed the world’s only 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.”

Source: EKOS Corporation, Business Wire

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