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The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SurgiMend PRS | Device | SurgiMend® PRS and SurgiMend® PRS Meshed are intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® PRS and SurgiMend® PRS Meshed are specifically indicated for plastic and reconstructive surgery, including breast reconstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of SurgiMend | The primary endpoint of this study is the proportion of patients who did not require additional surgical interventions at or associated with the site of the original reconstruction within 12 months after SurgiMend® PRS or SurgiMend® PRS Meshed implantation. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of SurgiMend | The secondary endpoint of this study is the occurrence of relevant (S)AEs within 12 months of SurgiMend® PRS or SurgiMend® PRS Meshed implantation. | 24 months |
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Inclusion Criteria:
The patient has reviewed the ethics-approved consent form and has provided consent for data collection
Subject is a female over the age of 18 at the time of index surgery (mastectomy)
Subject had mastectomy performed for cancer or as a cancer prophylaxis
The surgical plan included one of the following approaches:
If subject received bilateral breast reconstruction, the subject must have received the same surgical technique for both breasts including the implantation of SurgiMend® PRS or SurgiMend® PRS Meshed
If subject received unilateral breast reconstruction, there was no surgical intervention on the contralateral breast within 12 months post-operatively
Subject underwent mastectomy (index surgery) at a minimum of 24 months prior to study initiation at site
Exclusion Criteria:
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Data will be collected for 50 female subjects that have been implanted with SurgiMend® PRS and 50 female subjects that have been implanted with SurgiMend® PRS Meshed according to the IFU.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AULSS9 Scaligera | Verona | Veneto | 37122 | Italy | ||
| Ospedale Regionale di Lugano; Sede Ospedale Italiano |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 28, 2025 | |
| Reset | Sep 15, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 28, 2025 | Sep 15, 2025 |
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| Viganello |
| Switzerland |
| Royal Free Hospital | London | North West | NW3 2GQ | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | Yorkshire | S10 2JF | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| North Manchester General Hospital | Manchester | United Kingdom |