KCI's Prevena Incision Management System receives FDA clearance

Kinetic Concepts, Inc. (NYSE: KCI) announced today it has received 510(k) clearance from the Food and Drug Administration for the Prevena™ Incision Management System, a negative pressure wound therapy product designed for management of surgically closed incisions. KCI estimates more than three million procedures are performed each year worldwide that could benefit from treatment with the Prevena™ System, representing a potential global opportunity greater than $1 billion. The product will be available to hospitals in the U.S. in early July.

“I have used the Prevena™ Incision Management System on a number of cardiac surgery patients who were at high risk for wound complications. The results have been promising.”

"KCI's focus is on developing new technologies that improve patients' lives, something we have done again with the launch of the Prevena™ System," said Catherine Burzik, KCI's president and CEO. "It's another important milestone as we continue to execute on our growth strategy of commercializing a highly differentiated portfolio of products that help improve clinical outcomes and deliver tangible cost benefits."

The Prevena™ System is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by:

• Removing exudate and potentially infectious material
• Helping hold the edges of the incision together
• Protecting the surgical site from external contamination
• Providing a clean, protected postoperative wound environment

The Prevena™ System is designed for single-patient use. Portable and discreet, it accompanies the patient during transition from the hospital to the home.

"The Prevena™ Incision Management System represents the latest innovation to emerge from KCI's negative pressure technology platform and strengthens our growing portfolio of products designed specifically for the surgical suite," said Mike Genau, global president of KCI's Active Healing Solutions™ business. "Postoperative incision complications are serious clinical challenges often associated with poor patient outcomes and increased hospital cost. The Prevena™ System is already getting high marks from surgeons in Europe and Canada who have told us it addresses an important unmet need in the surgical suite."

Examples of complications that can follow surgical incisions include dehiscence, infection, hematoma and seroma. Sternal wound infections remain a serious complication from open-heart surgery, resulting in one-year mortality rates of up to 33 percent from mediastinitis after coronary artery bypass. The total annual cost to health care institutions for sternal wound infections alone has been estimated at more than $20 million.

"Effective postoperative management of incisions is vital because complications such as infection and dehiscence can compromise patient quality of life, prolong hospital stays and increase overall cost of care," said Mackenzie Quantz, MD, consultant, Cardiac Surgery, London Health Sciences Centre, London, Ontario and vice chair of the Specialty Committee in Cardiac Surgery at the Royal College of Physicians and Surgeons of Canada. "I have used the Prevena™ Incision Management System on a number of cardiac surgery patients who were at high risk for wound complications. The results have been promising."

The Prevena™ System has been available in Canada and Europe since spring 2010.