Health Science Center celebrates lifesaving device’s FDA approval
San Antonio (March 16, 2004) – The University of Texas Health Science Center at San Antonio is proud to have assisted in the development of the EZ-IO™ system for infusing medications, blood and fluids in emergency situations, Health Science Center President Francisco G. Cigarroa, M.D., said today.
Dr. Cigarroa responded to the news that the device’s maker, VidaCare™ Corp. of San Antonio, had received 510(k) clearance from the U.S. Food and Drug Administration to market the infusion system. The EZ-IO™, which allows intraosseous access through the bone marrow cavity, is expected to provide a viable alternative to traditional intravenous (IV) access, which often is difficult to start in patients whose veins have collapsed because of trauma.
“FDA approval is a major achievement,” said Dr. Cigarroa, a noted pediatric and transplant surgeon. “This innovation will save many lives and could become the standard of care in emergency medicine. We congratulate our colleagues at VidaCare™.”
“FDA approval confirms our sense that the device is both safe and effective for the proposed uses,” said Harold L. Timboe, M.D., associate vice president for administration at the Health Science Center and a member of the VidaCare™ Board of Directors.
Dr. Timboe, former commanding general of Brooke Army Medical Center in San Antonio and Walter Reed Army Medical Center in Washington, D.C., said the device combines straightforward science and existing technology, “resulting in potentially many lives saved in challenging circumstances – from paramedics coming upon an accident scene to battlefield casualty care to emergency departments in the hospital setting.”
The EZ-IO™ provides rapid and reliable access to the bone marrow cavity in about nine seconds through a hand-held, battery-powered drill. It is expected to assist some of the 12 million patients a year for whom starting an IV line is difficult and time-consuming.
The Health Science Center holds 6 percent equity in VidaCare™, which means if the company is sold and there is no dilution of ownership, the Health Science Center will derive 6 percent of the acquisition price. Alan Dean, director of the Office of Technology Ventures at the Health Science Center, credited Steven A. Wartman, M.D., Ph.D., executive vice president for academic and health affairs, with “giving us the freedom to construct what was then a unique licensing arrangement for this Health Science Center.” VidaCare™ has multiple patents to protect this platform technology from competition in the marketplace, Dean said.
The Health Science Center provided support and consultation during the product’s development, including protocols utilizing its laboratory animal resources department.
“It’s a great day for us and a great day for the Health Science Center, which has been a very supportive partner throughout the development of this device,” said VidaCare™ CEO Larry Miller, M.D. “I want to thank Drs. Cigarroa and Wartman for their understanding of a start-up company and what it takes to make this a success in the marketplace. This is an investment that should result in a significant benefit to the critically ill and injured in this country and on the world’s battlefields.”
VidaCare™ plans to market the EZ-IO™ in the United States, Canada and Europe. It will conduct marketing trials in about 20 U.S. centers and expects to roll out the product in June.