Los Angeles, CA – December 4, 2009 — Dr. Harlan Amstutz, pioneer of surface hip replacement and founding director of the Joint Replacement Institute at St. Vincent Medical Center, announced today that the United States Food and Drug Administration (FDA) has given approval to the CONSERVE® Plus Total Hip Resurfacing System which he developed. Manufactured by Wright Medical Group, Inc., the CONSERVE® Plus is now available in the United States. This innovative hip resurfacing system provides surgeons and their patients a less-invasive alternative to traditional total hip replacement.
The approval follows a successful clinical trial involving more than 1,300 patients demonstrating the results of the CONSERVE® Plus for up to eight years after surgery. Dr. Amstutz and Wright Medical Group will commence surgeon training in the first phase of its U.S. introduction. The training is expected to begin immediately.
CONSERVE ® Plus hip resurfacing retains and reshapes the femoral head instead of amputating the femoral head and neck as in total hip replacement. Further, there is no violation of the femoral canal. A thin metallic femoral component is simply placed over the reshaped femoral head and another thin metallic shell in placed into the reshaped acetabulum (hip socket). The contacting surfaces of the two shells are a precision-manufactured, low wear metal-metal bearing. Implant wear can lead to pain, bone loss, implant loosening and potentially complex and costly revision surgery.
The CONSERVE ® Plus femoral component has a relatively thin, tapered peg in graduated lengths, thus reducing the risk of stress shielding (loss of bone in the femoral neck). The acetabular shell has the largest coverage angle of the femoral head by the socket, resulting in less potential for edge wear with a greater range of safe movement.
CONSERVE ® Plus Hip resurfacing may be ideal for young and/or active patients in need of surgical treatment for chronic pain. The CONSERVE® Plus system is designed to offer pain relief and restoration of function while retaining as much healthy bone as possible and preserving future surgery options, including a primary total hip replacement.
“We are very excited about the long awaited FDA approval of the CONSERVE ® Plus device. I dreamed we were going to have a device that would predictably provide the young patient with maybe 10 years more time before a total hip replacement, stated Dr. Amstutz. “I now believe this device, when bone quality is good and recommended surgical technique is followed, can be a lifetime replacement. We will now begin training more U.S. surgeons with the CONSERVE® Plus device which has significant advantages over the other existing FDA approved resurfacing devices.”
Dr. Thomas P. Schmalzried, Medical Director of the Joint Replacement Institute at St. Vincent Medical Center, commented, “Over the past 9 years, I have witnessed amazing results in my own patients with the CONSERVE ® Plus. Patient selection and proper surgical technique are the keys to success. With FDA approval, there is now the opportunity to increase patient access to this less-invasive, high performance technology.”
About Joint Replacement Institute
Worldwide leaders in the surgical management of hip, knee and shoulder arthritis, the Joint Replacement Institute surgeons have operated on thousands of patients, trained numerous other surgeons in less invasive bone-conserving techniques, been widely published in scientific research journals, and lectured worldwide. Joint Replacement Institute is an outpatient clinic of St. Vincent Medical Center, recognized by the Centers for Medicare & Medicaid Services (CMS) for outstanding achievement in clinical quality initiatives. For more information about JRI, visit www.jri-docs.com.
About St. Vincent Medical Center
Providing compassionate healthcare and serving the sick poor has been the mission of St. Vincent Medical Center for more than 153 years. Located in downtown Los Angeles, St. Vincent is a world-renowned, 366-bed facility, offering comprehensive medical services, including multi-organ transplantation, joint replacement, general orthopaedics, cancer treatment, cardiovascular services, thoracic surgery, electrophysiology, interventional cardiology and the multi-disciplinary neurosurgery and neurotology services.
St. Vincent Medical Center is part of the Daughters of Charity Health System, a nonprofit Catholic healthcare system spanning the California coast.
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