P000054 Wyeth Pharmaceuticals, Inc' InductOs rhBMP2ACS Device

1
P000054Wyeth Pharmaceuticals, Inc.InductOs
(rhBMP-2/ACS Device)

• Restorative Devices Branch
• Division of General, Restorative and Neurological
  Devices
• Office of Device Evaluation
• Center for Devices and Radiological Health

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Review team Primary review team

• Aric Kaiser, MS - PMA lead reviewer
• Peter Hudson, PhD - lead preclinical reviewer
• Barbara Buch, MD - clinical reviewer
• Chang Lao, PhD - statistical reviewer

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Review teamAdditional review expertise

• Josie Yang, CDER
• Mercedes Serabian, CBER
• Barbara Wilcox, CBER
• John Hill, CBER
• Gary Kikuchi, CBER
• Carol Rehkopf, CBER

• Angel Torres-Cabassa, CDRH
• Martin Yahiro, CDRH
• Pam E Scott, CDRH
• Sergio Gadaleta, CDRH
• Erin Keith, CDRH
• Kevin Lee, CDRH
• Tracey Bourke, CDRH
• Nirmal Mishra, CDRH
• Carol Arras, CDRH
• Mary Ann Wollerton, CDRH
• Jean Toth-Allen, CDRH

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Device description

• InductOs (rhBMP-2/ACS Device)
• 2 component combination product
• growth factor - rhBMP-2
• recombinant human bone morphogenetic protein 2
• carrier/scaffold - ACS
• absorbable collagen sponge

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Indication for Use

• studied
• acute open tibia fractures stabilized by IM nails
• proposed
• "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"

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Submission history

• Original PMA
• not approvable letter issued
• 2nd submission
• reanalyses of original data to address not
  approvable issues and other deficiencies

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Data review

• Preclinical
• issues being addressed
• tumor promotion
• fetal development
• new ELISA assays
• Clinical and statistical
• outstanding issues to be discussed

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Panel questions

• Study design
• Effectiveness
• Safety
• Labeling