DVI Stops Shipment of Atherectomy Catheter.INDIANAPOLIS--(HealthWire)--May 17, 1995--Guidant Corporation today announced that its subsidiary, Devices for Vascular Intervention, Inc. (DVI (1) (Digital Video Interactive) An earlier compression technique that provided up to 72 minutes of full-screen video on a CD-ROM. Acquired by Intel in 1988 from RCA's Sarnoff Research labs, Princeton, NJ, DVI never caught on. ), has voluntarily stopped shipment of its AtheroCath-GTO(R) atherectomy catheter. This action is the result of a meeting initiated by DVI with the Food and Drug Administration (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. ), where certain modifications to the product and other regulatory issues were discussed. After approval of the AtheroCath-GTO catheter by the FDA, DVI made certain modifications to the product pursuant to feedback from physicians and to achieve manufacturing improvements. There have been no reports of any problems or injuries caused by the modifications. The stop shipment does not affect any product already distributed to customers. Because of DVI's commitment to full compliance with all applicable FDA requirements, DVI voluntarily informed the FDA of the modifications to the AtherCath-GTO catheter in order to obtain the agency's interpretation of the requirements. In addition, DVI is submitting to FDA a premarket approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) supplement covering the modifications for FDA's review. Until that review has been completed, DVI has voluntarily suspended shipment of the product in the U.S. DVI anticipates having ongoing discussions with FDA regarding the regulatory issues DVI raised, and expects to work closely with FDA to meet all applicable regulatory obligations. DVI will continue to ship the SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. EX(TM) atherectomy catheter pending FDA's review of the AtheroCath-GTO PMA supplement. For the first quarter of 1995, sales of the AtheroCath-GTO catheter were less than five percent of Guidant's total revenue. A leader in the medical device industry, Guidant Corporation provides innovative, cost-effective products and services to the global cardiology and minimally invasive surgery minimally invasive surgery Laparoscopic surgery, see there. See Laparoscopic cholecystectomy. marketplaces. Guidant comprises Advanced Cardiovascular Systems, Inc. (ACS (Asynchronous Communications Server) See network access server. ), Cardiac Pacemakers, Inc. (CPI), Devices for Vascular Intervention, Inc. (DVI), Heart Rhythm Technologies, Inc. (HRT HRT abbr. hormone replacement therapy Hormone replacement therapy (HRT) Also called estrogen replacement therapy, this controversial treatment is used to relieve the discomforts of menopause. ), and Origin Medsystems, Inc., and the company's international affiliates. CONTACT: Guidant Corporation, Indianapolis Emile S. Godfrey, 317/971-2030 or Devices for Vascular Intervention, Inc. William A. Hawkins III, 415/599-5600 |
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