Thoratec Announces First European Implant of Vectra Vascular Access Graft.PLEASANTON, Calif.--(BUSINESS WIRE)--Dec. 13, 1999-- Thoratec Laboratories Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : THOR), a medical device company, today announced the first European implant of the Vectra(TM) VAG VAG Vagina Vag Vaginal VAG Freiburger Verkehrs Ag (German transportation company) VAG Versicherungsaufsichtsgesetz (German: supervision of insurance companies act) VAG Vancouver Art Gallery (Vascular Access Graft). The implant took place at Albert Schweitzer Hospital The Medical Research Unit of the Albert Schweitzer Hospital was established in order to study major causes of disease burden in the local population. Since its foundation 25 years ago, it has become a leading African research centre, specialising in pathophysiology and treatment of in Dordrecht in the Netherlands. The patient, a 71 year-old man with polycystic polycystic /poly·cys·tic/ (-sis´tik) containing many cysts. pol·y·cys·tic adj. Having or containing many cysts. polycystic containing many cysts. renal disease, had been undergoing hemodialysis through a jugular jugular /jug·u·lar/ (jug´u-lar) 1. cervical. 2. pertaining to a jugular vein. 3. a jugular vein. jug·u·lar adj. dialysis catheter that was performing poorly, providing less than optimal hemodialysis. Less than 24 hours after the implantation of the Vectra VAG, the graft was accessed and used successfully for hemodialysis allowing removal of the jugular catheter. The hospital staff noted a rapid hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis) 1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means. 2. time of only four minutes after decannulation. This implant represents the first step preceding a European roll-out scheduled to begin early next year for Thoratec's distribution program for the Vectra VAG with Guidant Corporation (NYSE/PCX:GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ). The Guidant agreement covers worldwide marketing and distribution rights to the device, except in Japan. The Vectra VAG is CE Marked and available for sale in Europe and is approved in several other countries outside the U.S. The clinical trial in the U.S. is well underway with 140 patients enrolled. Thoratec anticipates completing this study and submitting a 510(k) to gain FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clearance to begin marketing as early as the middle of next year. The Vectra VAG, which incorporates Thoratec's proprietary biomaterial, Thoralon(R), is designed to provide access to the blood stream in renal failure patients undergoing hemodialysis. The device is primarily used as a shunt between an artery and a vein to gain access to the circulatory system. Thoratec believes that this device allows early cannulation can·nu·la·tion or can·nu·li·za·tion n. Insertion of a cannula. cannulation introduction of a cannula into a tubelike organ or body cavity. capability, similar or better patency pa·ten·cy n. The state or quality of being open, expanded, or unblocked. patency the condition of being open. to current products commercially available, rapid hemostasis times, and handling characteristics that are well received by implanting surgeons. "This is a critical step in our European distribution program with Guidant," said D. Keith Grossman, president and chief executive officer of Thoratec. "We are optimistic about the potential for this device, not only because of Guidant's strong presence in the marketplace, but also based on our experience with the Vectra VAG in those markets where it has been available," he added. Thoratec Laboratories Corporation is engaged in the research, development, manufacture and marketing of medical devices for circulatory support and vascular graft applications, all of which incorporate its proprietary biomaterial, Thoralon. For additional information about Thoratec, visit the company's Web site at http://www.thoratec.com. The portions of this news release that relate to future plans, events or performance are forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including announcements by the company's competitors, risks related to the government regulatory approval process, rapidly changing technology, an intensely competitive market and market acceptance of new products. These factors, and others, are discussed more fully in the company's annual report on Form 10-K for the fiscal year ended January 2, 1999, and the company's other filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. These forward-looking statements speak only as of the date hereof. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. |
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