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 FREMONT, Calif., Oct. 5 /PRNewswire/ -- Target Therapeutics Inc. (NASDAQ: TGET) today announced that it is pursuing changes to its Guglielmi Detachable Coil (GDC) system, an investigational medical device intended for the treatment of high-risk or inoperable cerebral aneurysms. These changes will have a negative financial impact on the company.
 During investigational clinical trials over the past three years, approximately 1,200 patients at 80 sites worldwide have been treated with the GDC. Early clinical results from these trials are promising. Recent evidence based on magnetic resonance imaging (MRI) examinations done on a limited number of patients treated with the GDC indicates that there is the potential for the creation of small metallic particles during electrolytic detachment of the coil. Artifacts attributable to such metallic particles have been observed on the MRI examinations of 13 patients, two of whom have experienced ischemic strokes. Although inconclusive, the presence of these particles, along with other pre-existing medical conditions, may contribute to the occurrence of an ischemic stroke.
 "It is important to point out that candidates for treatment with the GDC are at high risk for neurological injury because of their underlying disease and have, as a requirement to inclusion in the clinical trial, been judged to have no other acceptable therapeutic options available to them," said Gary R. Bang, Target's president and chief executive officer.
 "During the investigative stage of these trials, our goal is to optimize the performance and safety of the GDC by responding to occurrences that indicate possible problems associated with its use," continued Bang. "To that end, we have studied the phenomenon thought to be responsible for these latest MRI findings and feel that we have identified potential enhancements to the GDC technique and system which, when implemented, may eliminate the phenomenon as a source of concern. We have begun testing these changes, which we expect will be forthcoming.
 "We are contacting all GDC clinical investigators regarding these concerns and changes, and have made initial contact with the U.S. Food and Drug Administration (FDA) to present and discuss the development," said Bang. "We expect to work closely with the FDA to ensure the continuation of patient safety throughout the duration of these clinical trials."
 Target's Scientific Advisory Board, comprised of leading interventional neuroradiologists, has reviewed this situation and has concluded that, for patients with high risk or inoperable cerebral aneurysms for which there is currently no suitable therapeutic alternative, the decision to treat the patient with the GDC should be left to the discretion of the physician.
 "Ongoing clinical trial results indicate that the GDC is a valuable treatment for inoperable and high-risk cerebral aneurysms," said Dr. Fernando Vinuela, an interventional neuroradiologist at the UCLA Medical Center and a GDC clinical trial participating physician. "Based upon the serious condition of patients for whom use of the GDC is prescribed, the recognition of artifacts in such a small percentage of the test population does not significantly impact my decision to continue to use the GDC."
 Aneurysms are weak balloon-like defects that protrude from arterial walls and, left untreated, may rupture and cause hemorrhagic stroke. The GDC is an electrically detached micro-coil that by filling the cavity of the aneurysm and by promoting clotting is felt to provide protection from aneurysm rupture. The company filed an application for a 510(k) marketing clearance for the GDC with the FDA in November 1992.
 "Based on information currently available, the impact on the company's future revenue is unclear," said Bang. "Preliminary information indicates the effect on earnings for the September 1993 quarter to be approximately $500,000 to $2 million."
 Founded in 1985, Target Therapeutics Inc. develops, manufactures and markets specialized disposable micro-catheters, guidewires, micro-coils and angioplasty products. These therapeutic devices are used in minimally invasive non-surgical procedures to reach disease sites throughout the body via the circulatory system. Target's products allow highly targeted treatment of the diseased, ruptured or blocked vessels of the brain responsible for stroke, as well as other disease sites in the body that are accessible through small blood vessels.
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 /CONTACT: Analysts: Larry Tannenbaum, vice president, Finance and Administration, and chief financial officer, of Target Therapeutics, 510-440-7700; or Press: Bruce Voss of Edelman Public Relations, 415-433-5381, for Target Therapeutics/

CO: Target Therapeutics Inc. ST: California IN: MTC SU:

SW -- NYON1 -- 8631 10/05/93 03:01 EDT
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Publication:PR Newswire
Date:Oct 5, 1993

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