Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation
Tela Bio Inc
Summary
The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.
Eligibility
- Age range
- 22–75 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient is a female between the ages of 22 - 75, inclusive, at the time of enrollment (e.g. date of index surgical procedure); 2. Patient is planned for a first-time immediate unilateral or bilateral DTI pre-pectoral breast reconstruction following mastectomy for cancer or as cancer prophylaxis; 3. Patient is not a current cigarette smoker; 4. Patient is willing and able to voluntarily sign the IRB approved Subject Informed Consent Form; 5. Patient is willing and able to comply with the study requirements including completion of required follow-up visits, subject questi…
Interventions
- DeviceOviTex PRS
A multi-layer construct of extracellular matrix (ECM) derived from ovine forestomach and embroidered with polymer filament.
Location
- WakeMedRaleigh, North Carolina