KCI Announces FDA 510(k) Clearance of V.A.C.® Therapy for Management of Closed Surgical Incisions

New Indication Gives Surgeons More Flexibility in the Management of Closed Surgical Incisions

SAN ANTONIO - Friday, June 15th 2012 [ME NewsWire]

-(BUSINESS WIRE)-- Kinetic Concepts, Inc.announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market its proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy System, for the management of closed surgical incisions.

“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.

“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.”

Since 2006, surgeons across various specialties have conducted clinical studies demonstrating the benefits of managing surgical incisions post-operatively using V.A.C.® Therapy. In that time, 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. These studies 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 customizing 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.

Today, KCI is pleased to announce the addition of this new indication to its V.A.C.® Therapy System, offering more flexibility to surgeons in the management of surgical incisions.

About KCI

Kinetic Concepts, Inc. is a leading global medical technology company devoted to the discovery, development, manufacture and marketing of innovative, high-technology therapies and products for the wound care and therapeutic support system markets. Headquartered in San Antonio, Texas, KCI has significantly advanced the science of wound healing over the course of more than three decades. KCI's success can be traced to a history deeply rooted in innovation and a passion for significantly improving patient outcomes while reducing the overall cost of care for patients around the world. KCI's proprietary negative pressure technologies have revolutionized the way in which caregivers treat a wide variety of wound types. The V.A.C.® Therapy System has been used on more than 6 million wounds worldwide. Additional information about KCI and its products is available at www.KCI1.com.

Contacts

KCI Corporate Communications

Mike Barger, 210-255-6824

mike.barger@kci1.com