FDA clears Kinetic Concepts VAC therapy system for new indication
Kinetic Concepts (KCI), a medical technology company, has won 510(k) FDA clearance for Vacuum Assisted Closure, or VAC therapy system, for the management of closed surgical incisions.
The new indication for VAC therapy for closed incision management is expected to allow surgeons to treat longer incisions by customising the dressing accordingly.
KCI chief medical officer, Ron Silverman, said: "This new indication will allow more surgeons to provide their patients with the known benefits of VAC therapy for the management of their closed surgical incisions."
The FDA clearance will widen the benefits of negative pressure closed incision management to a broader spectrum of surgical incisions, according to the company.
VAC therapy promotes wound healing through negative pressure wound therapy.
By delivering negative pressure at the wound site through a patented dressing, VAC therapy assists in drawing wound edges together, removing infectious materials and actively promoting granulation at the cellular level.
The studies, which were conducted by surgeons across various specialties, demonstrated that the incisional VAC therapy is associated with improved clinical outcomes.
University of Maryland School of Medicine division of plastic surgery assistant professor Devinder Singh said VAC therapy on closed incisions is a powerful and cost-effective technique that has helped the patients heal - especially those with high risk incisions.
"I use negative pressure dressings on all of my abdominal wall reconstructions and sternal wound repairs and I've noted improvement in incision outcomes," Singh said.
Image: VAC Therapy promote wound healing through negative pressure wound therapy. Photo: courtesy of Noles1984.