Pulmonary embolism treatment
EKOS Corporation addresses treatment for pulmonary embolism
  • Thu, 05/03/2012 - 11:18am

Washington State’s EKOS Corporation announced two new clinical studies that will explore the safety and performance of its new pulmonary embolism treatment, a blood clot-busting ultrasound-accelerated thrombolysis. Whereas doctors used to give patients blood thinners that would dissolve a blood clot over two to four months’ time, ultrasound-accelerated thrombolysis melts blood clots that form in leg arteries or veins within hours.

EKOS Corporation boasts that studies Seattle I and II will round out data gleaned by another study it started in 2010.

“When completed, the ULTIMA and SEATTLE studies will represent the largest and most rigorous medical device studies in medical history for the treatment of pulmonary embolism,” said Dr. Samuel Z. Goldhaber, Professor of Medicine at Harvard Medical School and Director of the Brigham and Women’s Hospital Venous Thromboembolism Research Group.

Ultima is more than half enrolled and will be completed next year. Researchers have already begun collecting Seattle I data from its nine international sites. Seattle II enrollment will begin next month.

More than 600,000 people suffer from pulmonary embolism each year in the U.S., according to a U.S. Surgeon General report. Nearly 180,000 die from it. This toll is reportedly higher than AIDS, breast cancer, and auto accidents combined.

Pulmonary embolism occurs when a large blood clot from the veins of the upper leg or pelvis travels to the lungs and becomes lodged. The pressure that builds can cause heart attack-like symptoms, permanent disability, or death. Massive pulmonary embolism causes patients to deteriorate into cardiogenic shock, or shock caused by cardiac arrest, which means an inadequate amount of oxygen is flowing to cells. A submassive pulmonary embolism is less intense, but still life threatening. Patients are stable but show signs of cardiac dysfunction, or heart failure.

The Food and Drug Administration approved EKOS’ ultrasound system in 2005 to treat blood clots in arteries throughout the body. In 2008, the FDA extended its use for the pulmonary artery. The device has since received the European stamp of approval, the CE Mark, to treat massive and submassive pulmonary embolism.

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