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1、I. General InformationA. Device generic name: Dermal ImplantB. Device trade name: Artecoll, PMMA/Collagen ImplantC. ApplicanVs name and addressARTES MEDICAL, INC.4660 La Jolla Village Drive, Suite 825 San Diego, CA. 92122 USAD. PMA number*E. Date of Panel recommendation *F. Date of notice of approva
2、l to the applicant*(*to be completed by FDA )II. Indications for UseArtecoll is indicated for the correction of contour deficiencies of soft tissue.III. Device DescriptionArtecoll is composed of PMMA microspheres, 30 to 42 microns in size, suspended in a water based carrier gel composed of 3.5% bovi
3、ne collagen, 96.5% buffered, isotonic water for injection including 0.3% lidocaine.0.5 cc syringe containsPolymethylmethacrylate120 mg3.5% Bovine Collagen Solution0.4 ccBovine Collagen3.5%Phosphate Buffer2.7%Sodium Chloride0.3%Lidocaine Hydrochloride0.3%Water for Injection93.2%IV. Contraindications,
4、 Warnings, and PrecautionsContraindicationsArtecoll must not be injected if the patient has a positive response to the required Artecoll Test Implant. Refer to Artecoll Test Implant Package Insert for complete instructions for administration and evaluation of the test implant.Artecoll must not be us
5、ed in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.Table 7.Improvement in masked observer FFA Scale ratings from pre-treatment to three monthsTreatment AreaTreatmentNMeanStd.Dev.Std. Err.Mean RankMann-Whitney TestUPGlabell
6、ar FoldsArtecoll650.250.800.1067.12213.0.348Control750.350.600.0773.5Nasolabial FoldsArtecoll870.810.810.09107.02173.5.001Control880.150.790.0869.2Upper Lip LinesArtecoll530.180.640.0950.31236.5.454Control510.250.520.0754.8Mouth CornersArtecoll640.450.800.1083.61657.5.001Control770.010.660.0760.5To
7、determine investigator assessment of success with respect to how closely the treatment met the investigators initial expectations for correction, the investigators assessment (not masked) of success was rated using a five-point scale, with 1 corresponding to completely successful and 5 to not at all
8、 successful, at one, three and six months post-treatment. Descriptive statistics were used to characterize the investigator ratings. Table 8 summarizes the findings and the means are illustrated in Figure 1. By month three, ratings that are more successful were obtained for Artecoll than for Control
9、 in each treatment area. Mean investigator ratings of Artecoll were roughly at the very successful level at all follow-up points. Mean investigator ratings of success for Artecoll treatment were in the very successful1 range at all follow-up points while less successful for Control at months three a
10、nd six.Table 8.Investigator ratings of success for each treatment area at each follow-up timeTime (months)Treatment AreaArtecollControNMeanStd. Dev.Std. Err.Mean RankNMeanStd. Dev.Std. Err.Mean Rank1Glabellar Folds681.930.940.1174.82791.911.000.1173.30Nasolabial Folds931.990.890.0992.89932.061.030.1
11、194.11Upper Lip Lines611.880.820.1155.49542.020.880.1260.83Mouth Corners742.000.970.1166.91772.551.280.1584.733Glabellar Folds672.021.000.1261.51742.681.400.1679.59Nasolabial Folds891.900.870.0968.08893.071.410.15110.92Upper Lip Lines582.040.900.1243.58513.111.390.2067.99Mouth Corners682.080.940.115
12、1.85763.381.340.1590.976Glabellar Folds742.061.070.1257.91823.431.510.1797.09Nasolabial Folds971.730.690.0758.87964.051.320.13135.53Upper Lip Lines601.980.930.1236.76544.131.280.1780.55Mouth Corners732.190.980.1248.95814.091.320.15103.23Figure 1. Mean investigator success ratingsTo determine subject
13、 assessment of satisfaction with respect to the subjects personal expectations, the subjecfs assessment (masked) of satisfaction was rated using a five-point scale, with 1 corresponding to very satisfied and 5 to very dissatisfied,* at one, three and six months post-treatment. Descriptive statistics
14、 were used to characterize the satisfaction ratings. Table 9 summarizes the findings and the means are illustrated in Figure 2. By month three, more satisfied ratings were obtained for Artecoll than for the established Control implants in each treatment area. Mean satisfaction ratings for Artecoll were roughly at the satisfied level at all follow-up points while subjects showed lower satisfaction with Control at months three and six.Table 9.Subject ratings of satisfaction for each treatment area at each follow-up pointTime (months)Treatment AreaA
