Aesculap Unveils OrthoPilot -- Industry's First CT-Free Navigation System for Orthopedic Surgery.

Business Editors & Health/Medical Writers

NEW ORLEANS--(BUSINESS WIRE)--Feb. 5, 2003

New System Ensures Precise Implant Alignment and Positioning for

Optimal Surgical Results, Without Changing Preoperative Routine

Aesculap, Inc., the worldwide leader in orthopedic navigation, today announced the U. S. commercial availability of the OrthoPilot(R), the industry's first CT-free navigation system for orthopedic surgery. The system was unveiled at the American Academy of Orthopedic Surgeons conference being held here.

The OrthoPilot system provides surgeons with real-time, patient-specific information during knee surgery to ensure precise cuts and proper implant positioning without relying on manual techniques or requiring preoperative CT and MRI scans to be acquired, digitized and transferred into the system.

More than 350,000 knee surgeries are performed in the United States annually, including Total and Unicompartmental knee replacements, High Tibial Osteotomies and Anterior Cruciate Ligament (ACL) reconstructions. In most of these cases, surgeons use manual techniques to determine bone cuts alignment angles and ligament tensions. A mismeasurement, deviation in cutting angle, or inaccurate implant positioning can undermine the procedure and result in long-lasting pain and increased wear in a prosthesis.

In a recent study comparing 821 patients(1), approximately three of 10 individuals who received knee implants through traditional methods were found to have a prosthesis out of optimal alignment by more than three degrees. And one of 10 was out of out of alignment by 5 degrees or more. Yet, in surgical procedures supported by the OrthoPilot system, there was a 300 percent improvement in knee implant alignment accuracy.

"The OrthoPilot system provides the ability to confirm the precise position of every instrument before the procedure and confirm the accuracy of cuts and implant positions, which is simply not possible with manual instrumentation alone" said Dr. S. David Stulberg, Professor of Clinical Orthopedic Surgery at Northwestern University's Medical School and Director of Joint Reconstruction and Implant Surgery at Northwestern Memorial Hospital. "Obviously the more precise we are at each stage of the procedure, the greater the likelihood of achieving positive, long term outcomes for our patients."

The OrthoPilot system works like a global positioning system for the leg. A series of transmitters are strategically positioned on a patient's leg. As the leg is manipulated, an infrared camera tracks the movement of these transmitters and relays that information to the OrthoPilot computer. The computer analyzes these positions and the kinematics of the leg to create an anatomic drawing of the knee in real time, including all relevant axes, angles and distances. The surgeon then uses the OrthoPilot graphical display to guide cuts, to align and position the bone and implants and to balance soft tissue. The result is a more precise and reproduceable procedure than can be attained by manual techniques alone.

"In developing the OrthoPilot system our goal was to create an intuitive solution that surgeons can easily integrate into their current protocols and that compliments their own skills," said Kenneth Ludwig, Vice President and General Manager of Aesculap's Intelligent Implant Division. "With more than 10,000 surgeries in Europe completed, and based on feedback from our U.S. evaluation sites, we've accomplished that and more."

The system consists of the OrthoPilot computer and high-resolution, flat-panel monitor, instrumentation sets and an NDI POLARIS camera system, which can be positioned anywhere in the operating room. The entire system is housed in a portable cabinet enabling it to move quickly from one operating room to another. After surgery, components can be easily cleaned and disinfected and stored in the cabinet. Entire instrumentation sets, including transmitters can be autoclaved, there is no special treatment required for individual components.

Four surgery-specific software modules comprise the OrthoPilot Knee-Suite(TM), including Total Knee Arthroplasties ,Anterior Cruciate Ligament reconstruction, and High Tibial Osteotomies.. Each module utilizes specific instrumentation sets for the respective surgical procedure. Software modules for Unicompartmental Knees and acetabular cup positioning are nearing completion.

About Aesculap

Aesculap, Inc. is a subsidiary of Aesculap AG & Co KG and is headquartered in Center Valley, PA. Based in Tuttlingen, Germany, Aesculap AG & Co KG is the world's largest manufacturer of surgical instruments and medical devices. For more than 135 years, the company has provided customers with surgical instrumentation and implants for neurosurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparoscopic and general surgery and central processing in a mission to provide "All it takes to operate." Aesculap is a member of the B. Braun family of healthcare companies, currently the fourteenth largest healthcare company in the world. For more information about Aesculap and its products, please contact Aesculap Customer Service at 1-800-282-9000 or visit the Aesculap website at www.aesculap-usa.com.

(1) R.K. Miehlke, H. Kiefer, S. Kohler, J.Y. Jenny, W. Konerman, Navigation in Knee Arthoplasty Abstract, Combined ERASS & ARO-Congress, June 20-22, 2002 Berlin, Germany; Abstract Book No. T. 5,4.