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CARDIOPULMONICS REPORTS PMA SUBMISSION

 SALT LAKE CITY, May 18 /PRNewswire/ -- CardioPulmonics(R) Inc. (NASDAQ-NMS: CRDS) today announced that it has submitted to the United States Food and Drug Administration ("FDA") a Pre-Market Approval ("PMA") application for its IVOX(R) intravascular gas exchange device.
 The company believes that the PMA application for the IVOX device contains data which constitutes valid scientific evidence to support the safety and efficacy of the IVOX device and its use. However, since the company began its IDE clinical trial in 1989, the FDA PMA review process has become increasingly uncertain, long and complex. The FDA is now proposing and may require that clinical data from randomized controlled clinical trials be used to determine clinical benefit in PMA applications for new medical devices such as the IVOX device. The company's clinical trial design as approved by the FDA in 1989 and as amended in 1990 did not provide for, nor was it required by the FDA to include, a randomized control group of patients supported without IVOX, against which patients receiving IVOX augmentation could be measured.
 In an attempt to meet the FDA's current recommendations the company has included in its PMA submission data from a "comparison" group of patients against which IVOX-assisted patients can be contrasted, subject to the constraints of the original design of the IVOX clinical protocol. While the company has attempted to tailor its PMA submission to current FDA guidelines, acceptance of the company's PMA application by the FDA is uncertain. Providing the company's PMA application is accepted for filing, the company believes the PMA review process will be lengthy. The company intends to submit the information generated by the IVOX clinical trials to regulatory agencies in several European countries to seek approval for marketing the IVOX device.
 CardioPulmonics Inc. manufactures the IVOX device (Intravascular Oxygenator) under an IDE (Investigational Device Exemption) from the FDA (United States Food and Drug Administration).
 -0- 5/18/93
 /CONTACT: Herb Taus, president and CEO of CardioPulmonics, 801-350-3600/
 (CRDS)


CO: CardioPulmonics Inc. ST: Utah IN: MTC SU:

LS-JB -- LA016 -- 9953 05/18/93 16:37 EDT
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Publication:PR Newswire
Date:May 18, 1993
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