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| May 1997 | Vol. 5 Issue 6 |
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IN THIS ISSUE: U.S. I.D.E. received for TALENT" device. Live implant of TALENT" device completed in Australia. TALENT" to join EUROSTAR registry. Autologous endothelial cell sodding study started. Two-stage ultra-thin polyester stent graft study started. WorldMed sponsors Dr. Volodos to present 10 yr. human data. TALENT" system review and new developments. Editorial. WorldMed TALENT" to join EUROSTAR Endoluminal Graft Implant Registry EUROSTAR is a European registry established to collect and analyze data on endovascular abdominal aortic aneurysm repair. It is independent of commercial interests. Dr. Ann Tunstall, Director of Clinical Affairs, has met with members of the EUROSTAR Steering Committee, and affirmed the company's commitment to participate in the registry. Eight plus TALENT" implants have already been submitted to the registry. |
U.S. IDE Study of Bifurcated TALENT" Endoluminal Graft Begins April 1997WorldMed WorldMed started the pre-IDE process for the TALENT" device 20 months ago, August 1995, when the company presented to the FDA initial lab test results and data on 15 animal implants. Since then the company has undertaken an extensive battery of additional tests, based on discussions with the FDA. These tests include: 20+ additional animal implants including aneurysm models, finite element analysis, 10 year fatigue testing in pulsatile model (University of Miami Department of Biomedical Engineering), Class VI Biocompatibility testing (Viromed), sterilization validation, compression testing, pull testing, bend testing, deployment testing, and histopathological examination of TALENT" animal explants (Dr. J. Butany, Toronto Hospital, in association with Dr. F. Schoen of Harvard Medical School). The TALENT" device is comprised primarily of components which are already commercially available in the United States and have been used in thousands of human patients without significant complications. The TALENT" endoluminal graft is made with surgical grade 0.18mm thick polyester which has been used for surgical repair of aneurysm since 1982. Frank Criado, M.D. at the Union Memorial Hospital in Baltimore, Maryland is the principal investigator of this study in the U.S.A. Analysis of 1996 WorldMed Field Complaints - 0.06% for Heart Catheters In 1996 WorldMed shipped 31,900 heart balloon catheters, approximately 140 TALENT" stent grafts and more than 1000 localized delivery catheters. The TALENT" device was designed and manufactured by our Research & Development Department until January of 1997 when it was transferred to our Manufacturing Department. The composition of complaints was published in our February 1997 newsletter. WorldMed is committed to continuous quality improvement. All members of the company participate in the quality improvement program. Analysis of all complaints is a key part of this program. May 1997 - Number of TALENT" Implants Worldwide is over 300. Live TALENT" Implant Completed at Asia-Pacific Society of Interventional Radiology Congress in Melbourne Australia April 8, 1997 - A bi-furcated TALENT" endoluminal graft was successfully placed to treat a subrenal 6cm aorto-iliac aneurysm in a 75 year old male. A team consisting of Peter Milne, M.D. (Vascular Surgeon) Ken Thomson, M.D. (Interventional Radiologist, Chairman of Society) and G. Dorros, M.D. (Visiting Cardiologist from the USA) completed the procedure in less than 2 hours. The device sealed the aneurysm immediately. The patient was awakened at the end of the procedure and was discharged the following day. A follow up examination was made of a previous TALENT" implanted in a female patient in december of 1995 (16 months) at the Royal Melbourne Hospital. The examination showed that the aneurysm decreased in size and the device showed no signs of fatigue. The TALENT" has unconditional T.G.A. approval in Australia.
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