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February 4 February 3 January 2 ------------------------------------------------------------------------------------------ Contact:
Performed by Dr. John Lange and Dr. Paul Schwartz of Shasta Orthopaedics and Sports Medicine in Redding, California, the procedure fulfills the promise of computer-guided surgical navigation in orthopaedics by providing highly accurate implant alignment and real-time vision of the surgical site through an incision 60-percent shorter than that of traditional total knee replacement.
The substantially shorter incision means less trauma to underlying muscle and soft tissues--a benefit to patients that leads to a smaller scar, less post-operative pain and a faster return to physical activity. The high-precision alignment may extend the long-term survival of the implanted artificial knee, thus reducing the need for future corrective surgeries.
"We have taken a huge step towards the future of knee replacement surgery," says Dr. Schwartz. "Being the first surgeons worldwide to combine minimally-invasive total knee replacement surgery with computer-guided navigation in a single procedure is truly remarkable. It's hard to imagine the scope of the impact this technique will have on patients' lives."
“As surgeons, we have always wanted a longer-lasting, less invasive knee replacement procedure” says Dr. Lange. “This technique moves us closer to the day when a patient can return to physical activity soon after surgery and the knee implant will last for the rest of the patient’s life.”
Each year, 250,000 people in the United States and 600,000 people globally undergo total knee replacement surgery. During the procedure, the surgeon removes the top portion of the tibia and the lower portion of the femur, replacing the bone and cartilage with a metal and plastic device that simulates the natural hinge of the human knee. Traditionally, the incision for this surgery is between 8 and 10 inches in length, but using special mini-incision instruments developed with Dr. Steven B. Haas, Associate Chief of the Knee Service at the Hospital for Special Surgery in New York City, Smith & Nephew's technique uses an incision of approximately three and a half inches. In a study of 90 patients who received this surgery in 2002, Dr. Haas showed that post-operative physical rehabilitation was reduced by two months.
At present, this non-computer-guided mini-incision procedure is being evaluated by 10 surgeons in the U.S. and Europe, and more than 200 patients have received surgery using the instrumentation. It will be made widely available to surgeons globally this summer.
“Integrating our minimally invasive instrumentation with our Achieve line of computer-assisted total joint applications has been our long-term vision for this procedure," says Dave Illingworth, president of Smith & Nephew Orthopaedics. "Just as minimally invasive total knee replacement is moving through the early adoption phase, we have strengthened our position in the segment with a unique, high-precision solution. This surgery pioneers the next generation of joint replacement techniques."
Computer-assisted orthopaedic surgery combines data received from infrared cameras and surface mapping of the femur and tibia to track in real-time the precise position of the implant and the surgeon’s instruments relative to the patient's bones during surgery. On-screen prompts guide the surgeon to the ideal alignment of the implant and instruments in order for mathematically precise bone cuts to be made. Precise alignment may extend the life of the orthopaedic implant and extend the successful outcome of the procedure.
Smith & Nephew's original Achieve computer-assisted total knee replacement technique recently reached its first anniversary of clinical use. Drs. Lange and Schwartz performed the first fluoroscopy-based computer-assisted total knee replacement using Smith & Nephew's application on April 10, 2002. In the year since, surgeons in the U.S., Europe, Japan, Canada and Australia have performed more than 600 total knee replacements using the technique.
Smith & Nephew Orthopaedics has computer-assisted surgery development contracts with medical equipment providers BrainLAB, Medtronic and GE Medical Systems, and is working toward an open-platform environment that will allow Smith & Nephew implants and instrumentation to be used on a maximum number of computer hardware systems.
In March of this year, Smith & Nephew, plc, announced the company’s intent to combine with Centerpulse AG, the Swiss orthopaedic medical device manufacturer. The combined company will be the third largest orthopaedic device manufacturer globally, and will have the leading market share position in Europe.
Smith & Nephew Orthopaedics is a leading provider of joint reconstruction, trauma and clinical therapy products. Based in Memphis, Tenn., the company strives to combine industry-leading technology with its history of clinically proven products to deliver simpler, less invasive and more cost-effective procedures to the orthopaedic community.
The orthopaedics division is one of the three core businesses of Smith & Nephew plc, a global advanced medical devices company with a highly successful track record in developing, manufacturing and marketing a wide variety of innovative tissue repair products. These products are primarily in the areas of bone, joints, skin and other soft tissue. Smith & Nephew has extensive marketing and distribution capabilities, with established sales in more than 90 countries.
BrainLAB is a privately held company headquartered in Munich, Germany. BrainLAB develops, manufactures, and markets software-driven medical equipment. Its products allow physicians to provide treatment that improves medical outcomes while being more accurate, less invasive, and less expensive than traditional surgery.
For more than 13 years, BrainLAB has been a leading innovator in the fields of image-guided surgery and stereotactic radiosurgery. BrainLAB has offices in 13 countries and employs over 400 people. Achieve is a trademark of Smith & Nephew.
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Smith & Nephew Extends Revolutionary Oxinium™ Technology to Hip Implants
Already proven effective in a full range of knee implants, Oxinium technology addresses two primary concerns surgeons have about hip implants--wear and fracture, both of which can lead to premature implant failure and additional surgery. Oxinium implants provide patients with the toughness of a metal implant but the wear-reduction of ceramic, yet has been shown to have none of the risks commonly associated with either material.
"Oxinium technology's best-of-both worlds qualities give back to surgeons the confidence they've lacked when choosing between hip implant bearing surfaces," explains Smith & Nephew Orthopaedics President Dave Illingworth. "Presently, surgeons have to choose between the strength of metals and the wear resistance of ceramic surfaces. With Oxinium implants, surgeons and patients have the benefits of both." During a hip replacement procedure, the surgeon removes the top portion of the femur, replacing it with a metal stem with a ball on one end. In 90-percent of cases, this metal ball is made from cobalt chrome, a tough metal able to withstand the weight-bearing demands of the hip joint. The surgeon also removes the acetabulum, or hip socket in the pelvis, replacing it with a metal shell and plastic liner. Over time, as the new ball rotates against the plastic liner, the liner wears down and a follow-up surgery, usually 10 to 15 years later, is required to repair the implant.
In the past, surgeons have successfully reduced this life-shortening wear by implanting a hard, low-friction ceramic ball rather than a tough metal ball. The hardened surface of a ceramic ball resists the roughening associated with a metal ball, thus reducing the rate at which it wears down the soft plastic liner.
Although ceramics can extend the life of hip implants by reducing this wear, a major recall of ceramic implants by French manufacturer Saint-Gobain Desmarquest in 2001 reinforced surgeon concerns that some ceramic implants may be prone to fracture inside patients. As a result, only ten-percent of procedures now involve the use of ceramic implants.
"Before Oxinium components were available, the only recent bearing surfaces developed to address these issues were variations on older technology," explains Dr. Robert Barrack of Tulane University Medical Center, who last year became the world's first surgeon to implant an Oxinium hip ball. "There's no doubt ceramic implants' wear-reducing properties can extend the life of an implant since wear is the leading cause of implant failure. But most surgeons believe the risks and potential consequences for patients outweigh the benefits and they are hesitant to use them now. Cobalt chrome, despite its inferior wear characteristics, is the current standard material of choice."
Oxinium technology may change that decision. Oxinium implants are made from zirconium, an extremely biocompatible metal similar to titanium, the strong, light metal used in orthopaedic implants and airplanes. The metal is heated and infused with oxygen until the outer surface naturally transforms into a ceramic. Rather than converting the entire implant into ceramic, only the outermost portion of the implant--the layer that comes into contact with the plastic cup--takes on ceramic's smooth, hard qualities. The entire component retains the strength and flexibility of the original metal.
As a result, Oxinium hip implants are 4,900 times more abrasion-resistant than cobalt chrome and reduce implant wear by nearly 50-percent. However, since it is still a metal, the new implants have strength characteristics, such as shatter resistance, similar to cobalt chrome--a unique combination in the orthopaedic industry.
Each year, approximately 340,000 total hip replacement surgeries are conducted in the U.S., and 600,000 are performed globally. Smith & Nephew is introducing Oxinium hip implants for use in the United States, as well as in Europe, Australia and Canada, and by year's end, expects them to account for 25-percent of all of its hip ball implants.
The introduction of Oxinium hip components builds on Smith & Nephew's successful application of the technology in knee implants. In five years of clinical use, the company reports no material failures of Oxinium total knee implants. Introduced for sale globally in February 2001, Oxinium knees are now available in all three primary implant variations: cruciate-retaining, macrotextured and posterior-stabilized. Later this year, Smith & Nephew will introduce a revision option, as well as a less-invasive unicompartmental implant, or "uni knee," made with the Oxinium technology.
In 2002, Oxinium knee implant sales grew at more than 300-percent, with 25-percent of all Smith & Nephew knees now being made from the new material. The widespread acceptance of Oxinium technology has lifted Smith & Nephew to the orthopaedic industry's leadership position for knee implant sales growth.
Dr. Richard Laskin, co-Chief of the Knee Service at the Hospital for Special Surgery in New York City, will present the results of his five-year study of Oxinium knee implants at the American Academy of Orthopaedic Surgeons convention in New Orleans, February 5-7.
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Andrew Burns WAUKESHA, Wis. and MEMPHIS, Tenn. (February 3, 2003) – GE Medical Systems, a unit of General Electric Company (NYSE: GE), and Smith & Nephew (FTSE: SN and NYSE: SNN), the global advanced medical devices company, announced today a definitive agreement to jointly develop and distribute new orthopaedic reconstructive and trauma computer assisted surgery (CAS) software applications and instruments to operate on GE’s surgical navigation systems.
GE Medical Systems develops and markets surgical navigation systems used in ear, nose and throat (ENT), cranial, spinal and orthopaedic procedures. Together, GE and Smith & Nephew will develop and distribute new applications for orthopaedics, offering customers access to surgical navigation for Smith & Nephew applications and instruments on the GE’s OEC FluoroTrakÔ 9800 C-arm and InstaTrakÒ surgical navigation systems. It is estimated that more than 25% of all orthopaedic procedures will utilize surgical navigation technology within the next five to seven years.
“We are excited to be working with Smith & Nephew to offer new surgical navigation software applications and tools to Smith & Nephew’s orthopaedic customers,” said Karim Karti, General Manager, GE Medical Systems Navigation & Visualization. “GE is building upon its technology leadership in diagnostic imaging, 3D visualization, and electromagnetic (EM) tracking, to provide an open surgical navigation platform with the most comprehensive set of surgical navigation applications and instruments from an array of device manufacturers.”
Smith & Nephew is committed to accelerating the adoption of CAS tools by surgeons in orthopaedics. Scott Elliott, Vice President of Computer Assisted Surgery at Smith & Nephew, said, “By working with a leader in medical imaging, navigation and visualization, Smith & Nephew will be able to better meet the needs of healthcare professionals and their patients with innovative technology. Our mission is to provide CAS technology as an enabler for truly less invasive and more accurate knee, hip, and trauma applications to the orthopaedic community.”
Karti added, “This agreement with Smith & Nephew exemplifies GE’s commitment to serving the growing areas of minimally invasive and computer assisted surgery. These procedures are playing an increasingly important role in patient care because of the significant benefits associated with smaller incisions, shorter hospital stays and overall faster recovery times.” Both companies will be investing in software and instrumentation development, and by working with surgeons, will accelerate the technological advancements and applications available in surgical navigation for orthopaedic customers. ------------------------------------------------------------------------------------------ Smith & Nephew Orthopaedics drives focused growth with new Trauma, Reconstructive divisions Media Contact: Andrew Burns Memphis, Tenn. (January 14, 2003) -- Smith & Nephew plc (FTSE: SN and NYSE: SNN), the global advanced medical device company, has taken steps to enhance its Orthopaedic business' industry-leading sales growth by creating two separate divisions dedicated to its Trauma and Reconstructive customers. Designed to achieve focus, increase the company's speed of doing business, and improve customer satisfaction, the new structures integrate sales, marketing and product development into distinct operating divisions.
Scott Flora, previously Senior Vice President of U.S. and European Sales, has been named Senior Vice President and General Manager of the Trauma Division, and Steve Hirsch, previously Senior Vice President of Marketing, has been named Senior Vice President and General Manager of the Reconstructive Division. Both executives were chosen based on their broad experience in medical device sales and marketing and have been crucial to the recent industry-leading sales growth of Smith & Nephew's orthopaedic business.
In the December 17, 2002, trading update to investors, Smith & Nephew said it expects the company's Orthopaedic business to grow by 19-percent in 2002, with knee implant sales increasing 23-percent over the previous year. Trauma sales are anticipated to be 8-percent for the year – broadly in line with industry growth in this sector.
"By divisionalizing now," explains Smith & Nephew Orthopaedics President Dave Illingworth, "we are seizing the opportunity to capitalize on the tremendous growth of our knee and hip reconstructive business and to revitalize and strengthen our trauma business. Twenty-five percent of our revenue comes from products introduced in the last three years. By integrating the groups who develop and market our products, we can reduce the time required to deliver a product from the concept stage into the hands of our surgeon customers. This will result in gains in both revenue and market share, as well as in customer satisfaction and loyalty."
In a further effort to provide more specialized service based on the needs of surgeons, Smith & Nephew Orthopaedics will build teams of expert sales representatives focused exclusively on either trauma or reconstructive products. Adding to the existing group of clinic-based specialists, approximately 25-percent of Smith & Nephew's U.S. sales force will be exclusively dedicated to a specific sector of the business by the end of 2003.
"We are excited about the impact our new, focused divisions will have on our customers," says Illingworth. "In my first three months as President last year, I spoke with dozens of orthopaedic surgeons -- many of whom are customers, but some were not. The consensus among them was that the business that quickly delivers technologically advanced products through teams of focused experts stands to make the greatest gains in market share and customer loyalty. These moves position Smith & Nephew to be that company."
Smith & Nephew Orthopaedics is a leading provider of joint reconstruction, trauma and clinical therapy products. Based in Memphis, Tenn., the company strives to combine industry-leading technology with its history of clinically proven products to deliver simpler, less invasive and more cost-effective procedures to the orthopaedic community.
The orthopaedics division is one of the three core businesses of Smith & Nephew plc, a global advanced medical devices company with a highly successful track record in developing, manufacturing, and marketing a wide variety of innovative tissue repair products. These products are used primarily in the areas of bone, joints, skin, and other soft tissue. Smith & Nephew has extensive marketing and distribution capabilities, with established sales in more than 90 countries. ------------------------------------------------------------------------------------------ Media Contact: Andrew Burns Memphis, Tenn. (January 2, 2003) -- Global medical device maker Smith & Nephew (NYSE: SNN; FTSE: SN) today announces it has received U.S. Food and Drug Administration 510(k) clearance for its Achieve brand computer-assisted instruments and software for the accurate placement of the acetabular cup during hip replacement surgery. While the Achieve technology can be used in a conventional hip surgery, it also enables total hip replacement surgery through a mini-incision, providing a reduction in the soft tissue trauma and long rehabilitation normally associated with the procedure.
Using traditional techniques, surgeons have a view of the hip cup's abduction, or angle of inclination, but must estimate its anteversion, or lateral angle, due to restricted visualization during surgery. As a result, studies indicate as many as two-thirds of all acetabular cups are placed incorrectly and are at increased risk of post-operative dislocation. The Achieve surgical application, however, expands orthopedists' view of the surgical site, even through mini-incisions, by using specialized technology to track the movement of the instruments and implant relative to the patient's anatomy. The software provides the surgeon with onscreen views of both the cup’s abduction and anteversion, thus ensuring the cup’s precise placement.
"We are focused on developing safe, reproducible and less-invasive techniques while maintaining high quality implants and ensuring patient wellness," explains Scott Elliott, Smith & Nephew's vice president of computer-assisted surgery. "Hip surgery is moving in the direction of mini-incisions, and the Achieve surgical application provides Smith & Nephew's mini-incision hip replacement technique with a distinct advantage over competitors by providing views of the surgical site unimaginable before now."
Smith & Nephew's Achieve computer-assisted surgical applications provide orthopedic surgeons with improved procedural planning, surgical guidance, enhanced visualization and real-time surgical data capture. Achieve applications enable more accurate and less invasive orthopaedic procedures, potentially resulting in improved outcomes and a reduction in rehabilitation time. Smith & Nephew is the first orthopaedic company to receive FDA clearance for fluoroscopy-based, computer-assisted applications in knee, hip and trauma surgery.
Smith & Nephew Orthopaedics is a leading provider of joint reconstruction, trauma and clinical therapy products. Based in Memphis, Tenn., the company strives to combine industry-leading technology with its history of clinically proven products to deliver simpler, less invasive and more cost-effective procedures to the orthopaedic community.
The orthopaedics division is one of the three core businesses of Smith & Nephew plc, a global advanced medical devices company with a highly successful track record in developing, manufacturing, and marketing a wide variety of innovative tissue repair products. These products are primarily in the areas of bone, joints, skin, and other soft tissue. Smith & Nephew has extensive marketing and distribution capabilities, with established sales in more than 90 countries. Achieve is a trademark of Smith & Nephew.
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