Panel questions Study design Effectiveness Safety Labeling.

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Presentation transcript:

Panel questions Study design Effectiveness Safety Labeling

Study design Discuss the impact of the following on the ability of the study to collect clinically valid data: definition of standard of care in view of the multiple confounding factors clinical relevance of rate of secondary interventions required to promote healing as a primary endpoint reliability of interpretation of terms “union”, “healing”, “delayed union” and “delayed healing” at various sites

Effectiveness Accounting for trial design, resulting data and statistical analyses, discuss the adequacy of effectiveness in terms of: decrease in number of secondary interventions required to promote fracture healing; and accelerated fracture healing determined by: fracture healing at 6 months assessed by investigator fracture union assessed by independent radiologist

Safety Accounting for trial design and resulting data, discuss whether or not the sponsor has provided a reasonable assurance of device safety in view of: rate of authentic antibody response to rhBMP-2 and to bovine Type I collagen rate of hardware failure rate of infection rate of abnormal liver function lab values

Labeling Discuss the adequacy of data from experience treating acute open tibia fractures stabilized with IM nails to support a more general indication: "…the treatment of acute long bone fractures that require open surgical management. InductOs increases the probability of fracture healing, accelerates fracture healing, and decreases the frequency and invasiveness of interventions for delayed union or nonunion…"