Panel Questions

 

1.      Based on the study adverse events and other hypersensitivity data in the PMA, please discuss the hypersensitivity potential of Restylane to induce hypersensitivity reactions..

2.      21 CFR 860.7(d)(1) states that there is a reasonable assurance that the device is safe when it can be determined that the probable benefits to health from use of the device for its intended uses, when accompanied by adequate instructions for use and warnings against unsafe use, outweigh any probable risks.  Considering the data in the PMA, please comment on whether there is a reasonable assurance that the device is safe.

1.      21 CFR 860.7(e)(1) states that there is a reasonable assurance that a device is effective when it can be determined, based on valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will produce clinically significant results.  Considering the data in the PMA, is there reasonable assurance that the device is effective?  If you believe that there is a reasonable assurance of effectiveness, please comment on whether the data demonstrate that Restylane is superior to the control device (Zyplast) for the proposed intended use.

3.       

 

1.      Only two African-American patients were enrolled in the Restylane clinical study (i.e., patient #s 410 and 618).  Ten patients listed as “other” were enrolled and the remaining patients were Caucasian.  The study did not enroll sufficient numbers of specific ethnicities that may be at a higher risk for adverse clinical outcome, e.g., African Americans. 

1.      As stated in 21 CFR 860.7, is there reasonable assurance that the device is safe for its stated indication?

4.      If the device is approved, should the sponsor be required to conduct a post-approval study to collect safety data on specific minorities?  Is specific labeling needed to address potential use in minorities that may be at a higher risk for adverse clinical outcome, e.g., African Americans?
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  1.  

5.      Investigators treated 138 nasolabial folds in the study.  The sponsor proposes the following indications for use “Restylane is intended for temporary correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.”   Please discuss the adequacy of these indications based on the fact that only nasolabial folds were treated in the PMA.

 

3.Incidence of SRS at 6 months by evaluating investigator:

Restylane lower (better) than Control:        80 

Restylane equal to Control:         44

Restylane higher (worse) than Control:          13

 

 

Mean SRS Score by evaluating investigator:

                       N           Restylane     Control            Absolute                                             Difference

Pre-treatment       138        3.29         3.31      0.02

Baseline          138        1.80       1.79                0.01

6 months    134        2.36       2.94      0.58

 

SRS at 6 months was clinically significantly (1 unit, minimum) higher for Restylane than Control in 59.7% patients, but less than clinically significantly higher (0.6 unit) for the overall cohort.

 

a)As stated in 21CFR 860.7, is there reasonable assurance that the device is   effective for its stated indication in the target population?

a)Please discuss if Restylane is superior to Zyplast for its proposed intended use.

 

3.Based on the adverse event data in the PMA, please discuss if Restylane is safe for its proposed intended use.