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Noticias
The Only FDA Approved Endovascular Stent Graft for Use in Challenging Abdominal Aortic Aneurysm Cases
London, UK and Irvine, CA, November 18, 2013 – Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company focused on the treatment of abdominal aortic aneurysms (AAAs), today announces a stand-alone symposium and program of presentations to mark the formal US launch of Aorfix™, the Company's flexible stent graft, at the 40th Annual VEITH Symposium, November 19-23, New York Hilton Midtown Hotel, Manhattan, New York City.
CEO of Lombard Medical Technologies, Simon Hubbert, commented:
“Published clinical data suggest that up to 30% of patients present with tortuous AAA anatomy. US physicians now have access to Aorfix, a highly effective, FDA approved treatment option for such cases. VEITH Symposium is one of the most important annual gatherings of vascular surgeons from around the world and the ideal venue to formally launch Aorfix in the US.”
Aorfix was approved by the US FDA in February this year and includes a unique label indication for the treatment of patients with neck angulations up to and including 90 degrees. Lombard Medical will be hosting a launch stand-alone symposium, where leading physicians will present clinical data and provide their first-hand experience of Aorfix, on Thursday November 21, 12:00 noon to 1:00 PM.
Clinical discussions at the launch stand-alone symposium will be led by key investigators from the Pythagoras US clinical trial of Aorfix, including:
· Overall 1-year results of the Aorfix Pythagoras PMA Study – Mark F. Fillinger, M.D. Director, Vascular Surgery Training Programs, Professor of Surgery, Geisel School of Medicine, Dartmouth and Principal
Investigator for Lombard’s PMA Trial
· Anatomical angles and effect on Aorfix PMA Study results – Mahmoud B. Malas, M.D. Chief of Endovascular Surgery and Director of Vascular and Endovascular Clinical Research, Johns Hopkins
Bayview Medical Center
· Gender and its impact on Aorfix PMA Study outcomes – William D. Jordan Jr., M.D. Professor of Vascular Surgery, University of Alabama School of Medicine
· Access techniques for tortuous anatomy – Jeffrey P. Carpenter, M.D. Chairman and Chief, Department of Surgery, Cooper University Health Care
· Clinical insights from the Aorfix PMA Study – Kim J. Hodgson, M.D. Professor and Chair, Division of Vascular Surgery, SIU School of Medicine
In addition, Lombard Medical will host a meeting and product demonstration for investors and analysts on November 20, 2:30 PM to 4:30 PM at the Hilton hotel, no new material financial or other information will be disclosed.
The following presentations highlighting Aorfix will also take place at this year’s VEITH Symposium on Friday
November 22:
· Advantages and Limitations of the Lombard Aorfix Endograft. Now FDA Approved in the US – Mark F. Fillinger, M.D. Director, Vascular Surgery Training Programs, Professor of Surgery, Geisel School of Medicine, Dartmouth and Principal Investigator for Lombard’s PMA Trial
· Challenging Anatomy: Can Freedom from Adjunctive Fixation mean Freedom from Migration and Endoleak? – Prof. Brian R. Hopkinson, M.D., Emeritus Professor of Vascular Surgery, University of Nottingham; Consultant Vascular Surgeon, Queen's Medical Centre, Nottingham, United Kingdom.