Circulatory System Devices Panel

Questions for Discussion

CoSeal Surgical Sealant

P010022

 

September 11, 2001

Question #1

The preclinical sensitization testing demonstrated that this material causes a sensitization response in guinea pigs.

  1. The sponsor has agreed to address this issue in a labeling statement regarding the potential for sensitization in animal testing. Please discuss whether a labeling statement is adequate, of if additional testing is necessary to evaluate the sensitization potential of this material in humans.

Question #2

All of the adverse events seen in the US clinical study were expected for this type of procedure (e.g., edema, fever, erythema, infection, thrombosis, occlusion, hematoma, etc.) and none were attributed by the clinical investigators to CoSeal Surgical Sealant. However, the total number of adverse events in the treatment group (n=188 events, occurring in 56/74 patients) was higher than the control group (n=147 events including 2 deaths, occurring in 49/74 patients).

2. Please discuss the clinical importance of the overall adverse events and complications observed in these patients.

Question #3

One aspect of the pre-market evaluation of a new product is the review of its labeling. The labeling must indicate which patients are appropriate for treatment, identify potential adverse events with the use of the device, and explain how the product should be used to maximize benefits and minimize adverse effects. Please address the following questions regarding the product labeling (Section 2):

3a. The proposed labeling states that the sealant is indicated for use in "sealing arterial and/or venous reconstructions". The US clinical study investigated use of CoSeal Surgical Sealant in peripheral arterial bypass patching or grafting, and AV shunting for dialysis access. The European clinical study investigated use of the sealant in peripheral arterial bypass patching or grafting, AV shunting for dialysis access, and sealing of femoral arteriotomy sites.

Please discuss whether the clinical data provide adequate information to determine the safety and effectiveness of CoSeal Surgical Sealant for the proposed indication.

3b. Please comment on the DIRECTIONS FOR USE section as to whether it adequately describes how the device should be used to maximize benefits and minimize adverse events.

3c. Do you have any other recommendations regarding the labeling of this device?