Valiant Stent Graft system 'Mona LSA' of Medtronic demonstrates proof of concept in preliminary feasibility study

Presented at VEITH, acute results of initial testing of new medical technologies are promising for Endovascular treatment of thoracic aortic aneurysms involving the left subclavian arteryNew YORK– The first device of its kind to undergo clinical evaluation in the United States "Mona LSA" courageous system branch thoracic stent graft of Medtronic, Inc. (NYSE: MDT) has demonstrated proof of concept in a first human study being conducted by the U.S. Food and Drug Administration (FDA) "innovation via" early feasibility pilot programAccording to data presented today at the VEITHsymposium (TM) in 2013.The early feasibility study was approved by the FDA under an investigational device exemption and they recruited seven patients from the United States to demonstrate proof of principle and initial clinical safety. Results of seven patients acute procedure revealed 100% of technical success and permeability of 100 per cent in both and the stent graft branch. There is no type I or III endoleaks."The initial results of this preliminary study of feasibility are extremely encouraging," said Frank Arko, MD, vascular surgeon in heart & Vascular Institute of Carolinas HealthCare System Sanger in Charlotte, North Carolina, and one of two researchers of the United States of the study."This new technology potentially could reduce to a minimum the need for invasive surgery and extend the benefits without additional surgery endovascular repair of most patients with thoracic aortic aneurysms."Mona LSA brave system is designed to enable endovascular repair of thoracic aortic aneurysms and invading the left subclavian artery (LSA) to exclude the aneurysm of the blood flow while maintaining the perfusion of the LSA. Valiant Captivia leading market-based thoracic stent graft, the research system has a handful of branch which accommodates the LSA branch grafting. Its unique design eliminates the requirement of routine for the surgical bypass of the LSA, which is necessary after approximately 40% of cases of thoracic aortic aneurysm where the coverage of the LSA is required to achieve a seal with the stent graft area.Mona LSA brave system was the first of nine devices selected for evaluation as part of the path of innovation of the FDA, a new pilot program designed to promote emerging clinical research of new medical devices in the United States. More information about the program can be found on the FDA web site."Thoracic aortic aneurysms involving vessels branch such as the LSA can be particularly difficult to treat," said Eric Roselli, MD, a cardiothoracic surgeon at the Cleveland Clinic and national principal investigator of the study. "Mona LSA brave system could help to address an unmet need in the treatment of thoracic aortic aneurysms. This is clearly reflected in the decision by the FDA to help advance the development of this new therapy."In collaboration with leading scientists, researchers, and medical, Medtronic offers the widest range of innovative medical technologies for interventional and surgical treatment of cardiovascular disease, and cardiac arrhythmias. The company strives to offer products and services that offer clinical and economic value to providers and consumers of health around the world.ABOUT MEDTRONICMedtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology, alleviate pain, restore health, and extend the lives of millions of people around the world.Forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports in the file of the Securities and Exchange Commission. Actual results may differ materially from expected results.Tags:MEDTRONIC, Mona LSA, VEITHsymposiumCategory: articles, health