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Medtronic’s Securant > Lombard Medical > U.S. clinical trial for its EndoRefix endostapling device > New Stent Graft Fixation Device > Stent Stapler Closer to Launch

What are the limited European launch results that followed on the conclusion of a 10-patient clinical study? Is the clinical utility of EndoRefix to serve as an adjunctive procedure to endovascular abdominal aortic aneurysms stent-graft repair? Will Medtronic improve the proximal fixation of the Aneurx stent-graft with the technology?

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IIP > read on here > http://www.hemscott.com…

…Lombard Medical Technologies Plc. said it has begun the pivotal U.S. clinical trial for its EndoRefix endostapling device on schedule.

The company added that it has received full Food and Drug Administration approval of the investigational device exemption application for the trial, extending it to ten centres and up to 95 patients.

Trial recruitment is expected to be completed by the end of July and clinical data submitted to the FDA in September.

Chief executive Brian Howlett said the company continues to expect to receive market clearance for the product later this year…

This was written by admin. Posted on Wednesday, May 7, 2008, at . Filed under Complication of stent-graft repair, Paraplegia secondary to spinal cord ischaemia, Endovascular techniques prone to similar complications, Men in England are to be offered AAA screening, Interventional procedures, Interventional Cardiologists, Interventional Neuroradiologists, Interventional Radiologists, Aneurysm rupture, Type I endoleaks, Vascular disease, GORE EXCLUDER AAA Endoprosthesis, Life Line Screening, Surgical revision, Aorfix Dacron stent-graft, Stent graft migration following endovascular aneurysm r, Lombard Medical, Vascular Surgeons, Cook Medical, Endovascular repair of abdominal aortic aneurysms EVAR, Aortic aneurysms or occlusive disease, Endovascular Therapy, Endovascular resection, Medtronic's Securant, Closer to Launch, Stent Graft Fixation Device, EndoRefix endostapling device, Aortic Aneurysmal and Occlusive Disease, Aortic Stapler for End-to-End Anastomosis, Joseph Lombardi, Zenith Dissection Endovascular System, STABLE Aortic Dissection Trial, Thomas Jefferson University Hospital in Philadelphia, Zenith TX2 Endovascular Graft, Endovascular aneurysm repair EVAR, Endoscopic Surgical Procedures, Benefit from screening, Keep the graft in place, Surgical aneurysm repair, Open aneurysm repair, Watchful waiting, Elective surgical treatment of AAA, Endoaneurysmorrhaphy, Endovascular stenting, Larger aneurysms can leak or rupture, Totally laparoscopic AAA replacement, Treatment of aneurysms, Albert Einstein, Abdominal aortic aneurysm AAA, Ultrasound screening, Rupture of an abdominal aortic aneurysm, Endovascular stent graft, Silent killer, Sudden severe back or abdominal pain, Risk of developing AAA, Need for reintervention, Long-term graft performance, Stapling may replace stitching, Endoscopy Endoscopic, Scanning and visualizing the aorta, Stent Stapler, Stent graft fixation product, Endoleaks, Stent grafts have a tendency to migrate, Fixation of stent grafts, Screen the aorta, Welcome to Medicare physical, Subsidiary of a major stent-graft company, Warning letter, AAA stent-graft device, Stent-graft technology under serious scrutiny, Simple $50 ultrasound scan, Free screening for AAA, Ascending aortic aneurysm, Endoluminal Endolumenal Hollow Vessel. Bookmark the permalink. Follow comments here with the RSS feed. Post a comment or leave a trackback.

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