World Medical Receives Permission from FDA to Initiate Two New
Clinical Studies in the United States
SUNRISE, Fla., July 8 /PRNewswire/ -- World Medical Manufacturing Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to initiate human clinical studies of its TALENT(TM) Endoluminal Stent Graft System for treating aneurysms of the thoracic aorta. The company has also received permission to expand the Phase II IDE study of the TALENT(TM) device for treating abdominal aortic aneurysms (AAA) to an additional 150 patients with low to moderate surgical risk status.
The company previously completed enrollment in a Phase I study and has nearly completed enrollment in a Phase II IDE study in high risk patients in the United States. Foreign human clinical evaluation of the TALENT(TM) AAA device began in 1995 and CE Mark status was granted in Europe for both the AAA and thoracic models in the spring of 1998.
''World Medical is proud to sponsor the careful study in the United States of this exciting technology. We are providing numerous levels of support to this study including on-site technical and clinical staff for each case, advanced imaging services, a core laboratory, a full training and physician proctoring program, and a Physician Advisory Board. Aneurysms of the aorta, particularly the thoracic aorta, represent an extremely difficult disease to treat. Thoracic aneurysms are usually asymptomatic, presenting as an unsuspected mass on chest radiograph. When symptoms do occur, they are due to compression of adjacent structures, dissection, or rupture. Rupture occurs in up to 50% within 5 years and is almost uniformly fatal. The current standard treatment of descending thoracic aortic aneurysm is surgical resection of the aneurysm and replacement with a segment of prosthetic graft material. This surgical procedure has a mortality of up to 50% in emergency cases. In elective operations the mortality rate is lower, approaching 12%, however there is considerable morbidity, with paraplegia reported in 5-10%. Endovascular stent grafting utilizing the TALENT(TM) THORACIC and TALENT(TM) AAA devices offer a new alternative method of treatment which is potentially less hazardous and less costly, and potentially with a faster recovery time than standard operative repair, which will be evaluated carefully over an extended time period,'' said Howard J. Leonhardt, President & CEO of World Medical.
''The important work of many physicians conducting general research in this area has made this pioneering study possible. This includes; Robert Ersek, Alexander Balko, N. Volodos, E. Kornberg, Charles Dotter, Syde Taheri, E. Diethrich, G. Dorros, R. White, C. Donayre, M. Hallisey, B. Katzen, G. Becker, G. Coppi, U. Blum, K. Hausegger, J. Lammer, G. Biamino, H. Scharrer-Pamler, P. Fry, L. Machan, B. Bui, P. Capasso, L. Von Segesser, F. Criado, S. Ishimaru, D. Raithel, W. Stelter, M.L. Brown, K. Ivancev, K. Thomson, R. Waugh, G. White, M. Denton, P. Mossop, T. Chuter, J. May, F. Veith, T. Ohki, R. Uflacker, L. Hollier, H. Beebe, M. Marin, Juan Parodi, Michael Dake and Charles Semba. We gratefully acknowledge the contributions of these individuals and the many others who have advanced the overall field of endovascular research,'' Leonhardt further added.
On April 10, 1998, World Medical entered into a definitive agreement to merge with Arterial Vascular Engineering (Nasdaq: AVEI - news) a leading provider of coronary stents and other medical devices for the less invasive treatment of cardiovascular disease.
SOURCE: World Medical Manufacturing Corporation
|
