FDA Clears KCI’s V.A.C.® Therapy For Closed Surgical Incisions

In short

Kinetic Concepts, Inc.(KCI) has announced that it has received FDA 510(k) clearance to market its proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy System, for the management of closed surgical incisions.

Background

KCI’s  Negative Pressure Technology Platform includes a collection of products that deliver negative pressure to promote wound healing and/or address a variety of surgical challenges.

The company says that since 2006, surgeons across various specialties have conducted clinical studies demonstrating the benefits of managing surgical incisions post-operatively using V.A.C.® Therapy.

Ten studies have been published by surgeons representing multiple specialties and incision types, including abdominal wall reconstruction, foot and ankle surgery, traumatic surgery, abdominal wound closure and cardiothoracic surgery. KCI stats that these studies have demonstrated that incisional V.A.C.® Therapy is associated with improved clinical outcomes.

In 2010, KCI also introduced the Prevena™ Incision Management System, a portable disposable therapy system designed specifically for the management of closed surgical incisions of up to 8 inches, composed of a Peel & Place Dressing and a therapy unit pre-programmed to deliver up to 7 days of treatment, with negative pressure pre-set at -125mmHg.

The new indication for V.A.C.® Therapy for closed incision management will allow surgeons to treat longer incisions by customising the dressing accordingly. This will extend the benefits of negative pressure closed incision management to a much broader spectrum of surgical incisions, allowing more patients around the world to benefit from this therapy.

Company comments

“This new indication will allow more surgeons to provide their patients with the known benefits of V.A.C.® Therapy for the management of their closed surgical incisions,” said Ron Silverman, MD, chief medical officer, KCI.

Clinician comments

” V.A.C.® Therapy on closed incisions is a very powerful, innovative and cost-effective technique that has helped my patients heal – especially those with high risk incisions,” said Devinder Singh, MD, Assistant Professor, Division of Plastic Surgery, University of Maryland School of Medicine. “I use negative pressure dressings on all of my abdominal wall reconstructions and sternal wound repairs and I’ve noted improvement in incision outcomes. V.A.C.®Therapy has changed my practice forever, and for the better.”

Source: Kinetic Concepts, Inc.