Solventum Announces FDA 510(k) Clearance for Combined Use of Restrata™ Matrix and Solventum™ V.A.C.® Therapy*
Key Highlights
- ➤Solventum receives FDA 510(k) clearance for combined Restrata Matrix and V.A.C. Therapy use
- ➤Clearance follows Solventum’s December 2025 acquisition of Acera Surgical
- ➤Combined therapies may reduce dressing changes and streamline complex wound care
- ➤Restrata Matrix is 100% synthetic and fully resorbable for soft tissue healing
Expert Statements
Kelley Moffett, President of Advanced Wound Care at Solventum
“We're focused on delivering meaningful innovation that helps healthcare providers address clinical challenges and supports patients as they return to daily life”
Kelley Moffett, President of Advanced Wound Care at Solventum
“By combining Restrata™ Matrix's technology with our trusted V.A.C.(®) Therapy, we're giving clinicians an effective way to streamline care and support better patient outcomes.”
Matthew MacEwan, Ph.D., Chief Science Officer and Co-founder of Acera Surgical
“Complex wounds require clinicians to support tissue repair while also maintaining the right healing environment”
Matthew MacEwan, Ph.D., Chief Science Officer and Co-founder of Acera Surgical
“This indication brings those needs together in a single approach, giving clinicians another option to support healing more effectively across the course of care.”
Dr. Luis Fernandez, Professor of Surgery at The University of Texas at Tyler
“Restrata Matrix and V.A.C.(®) Therapy can succeed even in the most complex wound environments”
Dr. Luis Fernandez, Professor of Surgery at The University of Texas at Tyler
“With Restrata Matrix, I consistently see significant granulation tissue growth within a few days, even in the most challenging cases. Combining Restrata Matrix with V.A.C.(®) Therapy provides an even greater opportunity to promote healing and improve patient outcomes.”
Solventum Announces FDA 510(k) Clearance for Combined Use of Restrata™ Matrix and Solventum™ V.A.C.® Therapy* PR Newswire
* First-of-its-kind clearance combines two advanced wound care technologies into one path for active healing to help streamline care and improve patient outcomes * Clearance pairs innovative synthetic electrospun fiber matrix technology with an industry-leading negative pressure wound therapy to optimize healing EAGAN, Minn., Oct. 19, 2026 /PRNewswire/ -- Solventum (NYSE: SOLV), a leader in advanced wound healing, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the combined use of Restrata™ Synthetic Electrospun Fiber Matrix and Solventum™ V.A.C.(®) Therapy*. Following Solventum's acquisition of Acera Surgical in December 2025, this regulatory milestone brings two advanced technologies together into one path to support active wound healing.
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