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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namepump, drug administration, closed loop
ApplicantGENSIA, INC.
PMA NumberP940001
Date Received01/03/1994
Decision Date09/12/1997
Withdrawal Date 02/23/2001
Product Code
Docket Number 98M-0136
Notice Date 03/04/1998
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
This device indicated for delivering arbutamine, a catecholamine, through a closed-loop, computer-controlled drug-delivery system to elicit acute cardiovascular responses similar to those produced by exercise. In pts w/suspected coronary artery disease (cad) who cannot exercise adequately, stress induction with the genesa(r) system is indicated as an aid in diagnosing the presence or absence of cad. The effectiveness of the device has been demonstrate in clinical studies using radionuclide myocardial perfusion imaging to predict the results of coronary angiography. These studies were in patients with high and lower risks of cad and utilized blinded, central reading of images. Estimates of sensitivity, specificity and predictive values are presented in the "clinical trilas" section. Although the effectiveness of the genesa(r) system was also assessed in similar clinical studies utilizing echocardiography to predict the results of coronary angiography, the blinded, central reading of the images from the lower-risk echocardiography study was technically inadequate. Estimates of sensitivity, specificity and predictive values, based ont he non-blinded readings of echocardiograms at the local study sites, are presented for the lower-risk patients (see the clinical trials section of the genesa(r) (arbutamine) package insert). For the study of high-risk patients, the estimates are based on valid, blinded, central reading of images. Like exercise testing, cardiac stress testing with the genesa(r) system must always be performed under the direct supervision of a physician, and cardiac emergency equipment and supplies (defibrillator, intravenous b-blocker, etc. ) must always be available. Arbutamine must not be administered without use of the genesa(r) device.