Solventum Announces FDA 510(k) Clearance for Combined Use of Restrata™ Matrix and Solventum™ V.A.C.® Therapy*
Solventum received FDA 510(k) clearance for the combined use of its Restrata Synthetic Electrospun Fiber Matrix with V.A.C. negative pressure wound therapy, described as a first-of-its-kind pairing of the two advanced wound care technologies. The clearance follows Solventum's December 2025 acquisition of Acera Surgical, Restrata's developer, and is intended to streamline care by combining a fully synthetic, resorbable matrix with industry-leading NPWT for better healing outcomes.
Key figures
- Drug Name
- Restrata Synthetic Electrospun Fiber Matrix + Solventum V.A.C. Therapy
- Clearance type
- 510(k) combined-use indication
- Dressing wear time
- up to seven days per application
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