Becton, Dickinson (BDX) said Thursday that the first patient had been treated in its clinical trial for the use of GalaFlex Lite Scaffold to decrease capsular contracture recurrence during breast revision surgery.
Patient enrollment continues for the trial, which will evaluate whether GalaFlex Lite Scaffold will reduce the likelihood of capsular contracture and/or malposition in breast revision surgery, according to the company.
Becton, Dickinson said it expects to enroll at least 250 patients across 40 sites for the trial.
The company said the trial is intended to advance the product candidate towards premarket approval from the US Food and Drug Administration.
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