Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARTIA Reconstructive Tissue Matrix · 1 trial · 1 indication
Number of participants with at least one major complication related to breast reconstruction.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a medical device which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Acellular Dermal Matrix | EXPERIMENTAL | Breast reconstruction with ARTIA Tissue Matrix. |
| Name | Type | Description |
|---|---|---|
| ARTIA Reconstructive Tissue Matrix | DEVICE | Surgical Implant |
Inclusion Criteria: * Participants who will undergo unilateral or bilateral mastectomy upon enrollment. * Participants who are willing and able to undergo immediate prepectoral, implant based, two-stage breast reconstruction with ARTIA. Exclusion Criteria: * Has an existing carcinoma of the breas...
ARTIA Reconstructive Tissue Matrix is used for breast reconstruction. It is an investigational product being studied in adult female participants undergoing breast reconstruction procedures. The product is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
ARTIA Reconstructive Tissue Matrix is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and effectiveness of this product for breast reconstruction.
ARTIA Reconstructive Tissue Matrix is in Phase 3 clinical development. It is an investigational product, meaning it has not yet received regulatory approval. The ongoing Phase 3 trial is currently recruiting participants in the United States to evaluate its safety and effectiveness for breast reconstruction.
ARTIA Reconstructive Tissue Matrix is being evaluated in a Phase 3 clinical trial with the identifier NCT06575192. This study, titled ADORA, is assessing the safety and effectiveness of the product in adult participants undergoing breast reconstruction. The trial is recruiting 264 female participants in the United States.
ARTIA Reconstructive Tissue Matrix is not FDA approved. It is an investigational product currently in Phase 3 clinical development. The ongoing clinical trial is evaluating its safety and effectiveness for breast reconstruction, but regulatory approval has not been granted.