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Thursday, October 06, 2011 - Arizona Heart Institute Physician Invention Receives FDA Approval

PHOENIX (October 6, 2011) – A new medical device, originally invented by Dr. Venkatesh Ramaiah, a vascular surgeon at Arizona Heart Institute and Arizona Heart Hospital, recently received FDA approval for the treatment of aortic aneurysms.

The “UnBalloon™” is a specially constructed tool that expands and shapes stent grafts that are used to create a new path for blood flow in the aorta away from an aneurysm. An aortic aneurysm is a "bulging" of the major artery which arises from the heart, a serious condition prone to rupture and sudden death. Traditional treatment for aortic aneurysms is open surgical repair, which is an invasive operation associated with longer recovery times.  A more modern, minimally invasive endovascular method uses stent grafts, which are metal stents covered by a fabric graft material, and typically results in shorter recovery times for the patient.  During the endovascular procedure, a balloon catheter is often positioned and inflated to expand and shape the stent graft to the patient’s normal anatomy. However, during balloon inflation, a phenomenon referred to as “wind sock” may occur, which is the rapid, although temporary increase in blood pressure and reduced blood flow to major arteries that branch off of the aorta. The Unballoon™, on the other hand, which is constructed of an open wire mesh, is designed to function like a balloon catheter while allowing for continued blood flow through the device to maintain normal blood pressures intraoperatively.


Venkatesh Ramaiah, MD

“We are excited to have The UnBalloon commercially available in the United States,” said Dr. Ramaiah, who began development of this product in 2006. “With continued innovation like The UnBalloon, endovascular specialists will have even more options to more effectively treat patients with aortic aneurysms.” The Unballoon was originally developed by Dr. Ramaiah together with Robert McNutt, a radiology technician, and in conjunction with Arizona Heart Innovative Technologies, LLC. The device is manufactured, marketed and sold by Burlington, Massachusetts-based LeMaitre Vascular, a developer and manufacturer of devices for use in both open vascular surgery and minimally invasive endovascular procedures.

About Arizona Heart Institute

Arizona Heart Institute (AHI) is among the world’s leading providers of cardiovascular care. Founded in 1971, AHI has earned its reputation for excellent by creating a state-of-the-art facility that specializes in the prevention, diagnosis and treatment of heart and blood vessel disease. Through dedication, education and innovation, AHI is leading the effort to eliminate cardiovascular disease and discovering new ways to save lives along the way. For more information, please visit www.azheart.com.

About Arizona Heart Hospital

Arizona Heart Hospital, a Campus of Phoenix Baptist Hospital, is a 59-bed regional center of excellence dedicated exclusively to cardiac and cardiovascular care. The hospital’s innovative patient-centered approach organizes teams of physicians, nurses, and support services around patients’ needs, offering significant enhancements in the ability to deliver excellent care at lower costs. For more information, please visit www.azhearthospital.com.