Solventum receives FDA 510(k) clearance for combined Restrata matrix and V.A.C. therapy

Solventum announced that the U.S. Food and Drug Administration has approved the joint use of its Restrata™ synthetic electrospun fiber matrix with Solventum™ V.A.C.® negative‑pressure wound therapy. The clearance follows Solventum’s purchase of Acera Surgical, the developer of Restrata, in December 2025. Company executives said the combined approach should simplify wound‑care workflows and improve patient outcomes.

The clearance enables Solventum to market a new integrated wound‑care solution, potentially expanding its product portfolio and revenue opportunities, as noted by the company’s press release.

  • 1The FDA granted 510(k) clearance for the combined use of Restrata™ matrix and Solventum™ V.A.C.® therapy.
  • 2Solventum acquired Acera Surgical in December 2025, the developer of Restrata™ matrix.
  • 3Kelley Moffett, president of Advanced Wound Care at Solventum, said the combination gives clinicians a way to streamline care and support better patient outcomes.
  • 4Restrata™ matrix is a fully synthetic, resorbable product that supports soft‑tissue healing and degrades by hydrolysis.
  • 5Solventum™ V.A.C.® therapy provides negative‑pressure wound therapy and can be used with dressings that remain in place for up to seven days per application.

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