FDA Approves Ground Breaking Endovascular Aortic Repair Devices
Published date : 01 October 2012
Article date : 01 October 2012
Healthcanal.com reports on 2 devices, recently approaved by the FDA apparently offer more life-saving options to patients experiencing aortic disease or injury. Both devices were tested in clinical trials at the University of North Carolina School of Medicine have been approved by the FDA.
They say that the first device, the RELAY Thoracic Stent Graft with PLUS Delivery System manufactured by Bolton Medical, is designed to treat thoracic aortic aneurysms (the 13th leading cause of death in the US) occuring in the aorta as it passes through the chest. Apparently, the device offers a range of sizes and ease of use to help to expand the use of the minimally-invasive treatment to a broader segment of patients. The US study included more than 120 endovascular patients at 30 hospitals across the country.
Healthcanal describes the second device, the Conformable TAG Thoracic Endoprosthesis, manufactured by Gore Medical as used for endovascular repair of a traumatic thoracic aortic transection. They say that over 8,000 people each year (US) experience a transection of their aorta, involving profuse bleeding and high mortality rate - most often caused by a severe injury to the chest as a result of a motor vehicle accident, crushing of the chest, or a high fall.
Apparently, prior to the successful clinical tria, the only treatment option for traumatic thoracic aortic transection was open surgical repair; the minimally-invasive endovascular repair of traumatic thoracic aortic transection reduces recovery time and pain for patients who have experienced this type of transection.
Source: healthcanal.com, 27 September 2012
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