FDA Clears EKOS EkoSonic Endovascular System

EKOS said Tuesday that the FDA has cleared its EkoSonic endovascular system for use in treating pulmonary embolism. The device provides ultrasound-assisted, controlled and selective intravenous infusion of physician-specified fluids, including thrombolytics.

The device — the only FDA-cleared, minimally invasive endovascular therapy on the market, according to EKOS — is designed to accelerate the penetration of thrombolytic agents into blood clots, breaking them down before they can cause serious harm or death.

According to the Bothell, Wash.-based company, a subsidiary of BTG International, the standard treatment for pulmonary embolism is thrombolytic agents administered through an IV. But that can cause complications: too little of the agent doesn’t dissolve the clot fast enough, while too much can cause dangerous or even deadly bleeding elsewhere in the body.

“The challenge has been to minimize the major bleeding complication of intracranial hemorrhage, which occurs 10 times more often with IV-administered thrombolysis than with anticoagulants alone,” said Samuel Goldhaber, principal investigator of the SEATTLE II EkoSonic clinical trial, upon which 510(k) clearance was based.

The EkoSonic is currently available in the U.S. for the treatment of blood clots, EKOS spokesman Chris Gale told Device Daily Bulletin.

Pulmonary embolisms occur when something, often a clot, blocks the main artery to the lungs or one of its branches. Failure to treat it can lead to serious complications and death. — Kellen Owings

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