NOVOSTE CORPORATION ANNOUNCES FDA APPROVAL TO PROCEED WITH HUMAN CLINICAL TRIAL OF ITS INTRACORONARY BETA IRRADIATION CATHETER SYSTEM
For Coronary Restenosis
NORCROSS, Ga., Sept. 11 /PRNewswire/ -- The Food and Drug Administration granted Novoste Corporation an Investigational Device Exemption (IDE) today to perform a feasibility study of its intracoronary beta irradiation catheter system for the prevention of post-angioplasty restenosis. Novoste believes it is the first company to receive such an approval. The IDE application was filed on June 19, 1995, to conduct the study at Emory University Hospital in Atlanta, Georgia. Spencer B. King III, M.D., is the principal investigator for the study.
The Novoste catheter system is intended to be used immediately following a balloon angioplasty procedure. The catheter is positioned at precisely the same location where the balloon angioplasty took place. Beta radiation is then delivered locally to the section of arterial wall previously stretched by the balloon. The total body exposure from this procedure typically represents less than 1% of the radiation exposure a patient receives from the routine imaging of the coronary anatomy by x-ray during balloon angioplasty. Novoste estimates the additional time required to perform this procedure will be just a few minutes. The adjunctive procedure is intended to reduce the incidence of restenosis, the renarrowing of arteries after an interventional procedure such as angioplasty.
Restenosis occurs in approximately 40% of all angioplasty procedures, and Novoste estimates the cost of associated revascularization procedures approaches $3 billion annually in the U.S. alone. A successful preventive treatment for restenosis would therefore represent a substantial cost savings for the health care system, as well as improve the lives of hundreds of thousands of patients with coronary artery disease.
Novoste Corporation is a privately-held enterprise based in Norcross, Georgia. The company is focused on the development of patent-protected medical devices for use in interventional medicine. Novoste is placing direct distribution for the intracoronary beta irradiation catheter system in the U.S., although it typically structures alliances with market leaders for the marketing of its products. Novoste's development programs are presently concentrated in two of the fastest-growing medical specialties, Interventional Cardiology and Electrophysiology.
/CONTACT: Thomas D. Weldon, President & CEO of Novoste Corporation, 404-717-0904; or Desmond Towey or Bernadette McLaughlin, both of Desmond Towey & Associates, 212-888-7600/
CO: Novoste Corporation ST: Georgia IN: MTC SU:
TM-DC -- NY010 -- 7802 09/11/95 08:45 EDT
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|Date:||Sep 11, 1995|
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