Intratech Medical, developer of the Booster spiral balloon therapy for the treatment of AMI patients, announced the successful enrollment of two patients in a multi-center first in human study to assess the safety and technical performance of their Booster balloon in the treatment of patients undergoing coronary catheterization following AMI.
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This is the first ever study for treatment of acute heart attacks, using a spiral design balloon intended to minimize infarct size growth, by elevating pressure in the heart's vasculature.
Immediately following the revascularization of the clogged artery, the proprietary Booster balloon is placed in the coronary sinus (the main vein which drains the blood from the heart). Due to its unique spiral design, the Booster balloon causes temporary restriction of blood outflow, which elevates the vascular pressure, without compromising the blood outflow. This elevated pressure improves oxygen delivery to the ischemic myocardium, reducing the infarct area and ultimately improving patient outcomes.
"With over 9 million annual deaths from heart attacks, there is an urgent need for more effective intervention. The Booster balloon can revolutionize the last frontier in ischemic heart disease management, improving the lives of millions of people worldwide, while decreasing related health care costs," said Moshe Barel, Executive Chairman of Intratech Medical.