October 1, 2006Journal of Interventional Cardiology

Off‐Label Use: An Industry Perspective on Expanding Use Beyond Approved Indications

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Population

>7,000 patients in the ARRIVE registry receiving the TAXUS stent

Design

Review

Authors

MRMary E. RussellFamily Research Institute MFMark I. FriedmanMonell Chemical Senses Center SMStephen R. MascioliUniversity of Minnesota

Discussion

Member takes

Implication

Supports registry use for device label expansion strategies; leaves open effects on outcomes or regulatory efficiency pending prospective data.

Structured PICO

Population

>7,000 patients in the ARRIVE registry receiving the TAXUS stent

Intervention

TAXUS Express2 Paclitaxel-Eluting Coronary Stent System

Outcome

Practice patterns and safety outcomes (on-label and off-label use)safety

Real-world registries can provide a data-driven approach for industry to evaluate off-label use and initiate formal label expansion programs for medical devices.

Cite This Study

Russell et al. (2006) studied this question.

synapsesocial.com/papers/6a851f360b777c8ef09646f4 https://doi.org/10.1111/j.1540-8183.2006.00185.x

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Implication

Supports registry use for device label expansion strategies; leaves open effects on outcomes or regulatory efficiency pending prospective data.

Off‐Label Use: An Industry Perspective on Expanding Use Beyond Approved Indications

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Off‐Label Use: An Industry Perspective on Expanding Use Beyond Approved Indications

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Also Consider

Also Consider