FDA 510(k) Clearance for Combined Use of Restrata Matrix and Solventum VAC Therapy

Solventum has announced 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.  

“We’re focused on delivering meaningful innovation that helps healthcare providers address clinical challenges and supports patients as they return to daily life,” said 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.” 

Restrata Matrix and V.A.C.® Therapy are engineered to support various stages of the healing journey:  

Restrata is a 100 percent synthetic, fully resorbable matrix engineered to support soft tissue healing. It supports tissue formation through structural cues rather than growth factors to create the foundation for soft tissue repair. Built to perform in challenging wound environments and resist enzymatic degradation, Restrata Matrix allows for cellular infiltration, neovascularization, and organized collagen deposition. It degrades via hydrolysis over time, leaving native tissue behind.

V.A.C.® Therapy delivers negative pressure wound therapy (NPWT) to create an environment that promotes wound healing. When used with dressings like Solventum™ V.A.C.® Peel and Place Dressing, V.A.C.® Therapy helps maintain close contact between the matrix and the wound bed. Macrostrain draws wound edges together while microstrain stimulates cell proliferation, angiogenesis, and granulation tissue formation. It promotes perfusion, reduces edema, and removes fluid and infectious material for up to seven days per application.

“Complex wounds require clinicians to support tissue repair while also maintaining the right healing environment,” said 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.” 

Applied together, Restrata Matrix provides structural support for soft tissue repair, while V.A.C.® Therapy helps create an optimized environment that supports tissue integration. Restrata Matrix’s synthetic profile enables resistance to enzymatic degradation and aligns with V.A.C.® Peel and Place Dressing’s wear time of up to seven days, whereas many collagen-based dressings degrade prematurely and therefore aren’t optimal for concomitant use. Together, these therapies may allow for fewer dressing changes, less disruption to the healing environment, and a more predictable workflow for care teams.

"Restrata Matrix and V.A.C.® Therapy can succeed even in the most complex wound environments,” said 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." 

To learn more, visit go.Solventum.com/AdvancedWoundHealing.