Cerapedics Gains FDA Approval of IDE Supplement


FDA approved Cerapedics' Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the ongoing ASPIRE clinical trial for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF). Enrollment is reduced from 364 to 270 patients, leading to an earlier premarket approval (PMA) submission.

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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