Complete transcript will be available at
The Neurological Devices Panel (the Panel) met on Tuesday, November 30, 2004 in Gaithersburg, MD to make a recommendation to the Food and Drug Administration (FDA) on the approvability of Confluent Surgical, Inc.’s PMA, P040034 for the DuraSeal™ Dural Sealant System intended for use as an adjunct to sutured dura repair during cranial surgery to provide watertight close. The Panel membership for this meeting consisted of five neurosurgeons, two neurologists, an interventional neurological radiologist, a toxicologist, a statistician, a consumer representative, and an industry representative.
The sponsor presented its information on the safety and effectiveness of the device, and FDA reviewers summarized the data in the PMA. Two Panel members, a toxicologist and a neurosurgeon then gave their perspectives on PMA data. After deliberations on the information in the submission, the Panel considered FDA’s questions.
The Panel then voted seven to two with no abstentions that FDA approve the PMA with conditions. The recommended conditions of approval are as follows:
- The sponsor should conduct a postmarket surveillance study of the infection rate of patients treated with device.
- The sponsor should provide data regarding MRI and CT imaging analyses to demonstrate the characteristics of the image viewed upon MRI and CT and the duration of time it will be seen.
- Labeling recommendations included:
- A boxed warning statement that there was an increased infection rate observed in the clinical study patients.
- A statement of the total infection rate in the clinical study patients; the infection rate should not separated or stratified.
- A statement that the device should be used only as an adjunctive closure measure.
- A statement that the device material appears on MRI imaging for a determined period of time after application.
- A warning statement that the device-induced inflammatory response has not been studied.
- A statement that the device should be used where primary watertight dural closure cannot be achieved.
- A statement in the clinical summary that the device is effective in the studied patient cohort.
Contact: Janet L. Scudiero, Executive Secretary, at 301-594-1184 ext. 176 or email@example.com.
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