Aesculap Implant Systems, LLC, has announced the launch of the S4 Element Pedicle Screw System. The S4 Element Pedicle Screw System was made available to a select group of surgeons in May 2009 as part of the company’s Market Preference Evaluation, and a full launch of the system is planned for the second quarter of 2010, at which time the system will be released to surgeons throughout the United States. Aesculap notes that some of S4 Element’s unique features include an industry-leading ultra-low-profile screw head for minimal impingement of anatomical structures and innovative placement instruments, like the speed-multiplier handle, which facilitates tapping and screw placement at a 3.5 times faster rate without altering bone–screw thread properties. The S4 Element System will be sold through the Aesculap Implant Systems direct and indirect sales network. For more information, contact
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Soft-Tissue Repair
KFx Medical Corporation announced it has received 510k clearance from the US Food and Drug Administration (FDA) for products used in a wide variety of arthroscopic tenodesis knee procedures, such as anterior cruciate ligament, posterior cruciate ligament, and medial patellofemoral ligament reconstruction. KFx Medical has also received 510k clearance from the FDA for its AppianFx™ product line for soft-tissue repair and reconstruction in the knee. The AppianFx line of implants from KFx reattach tissue to bone in shoulder, knee, foot, and ankle procedures, which, combined, exceed well over 1 million annual surgical procedures. Product offerings include those that directly place and secure tissue into bone both with and without the use of sutures. For more information, contact KFx Medical Corporation |
Hindfoot Deformities and Arthritis Treatment
Wright Medical Group, Inc., has announced the full commercial launch of the VALOR® Hindfoot Fusion Nail. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial premarket availability announced in November 2009, the system has been limited to use in a few centers in the United States, gathering early clinical results. With an array of sizes and anatomical screw positions, the VALOR® Nail is designed to provide optimal fixation for each patient’s unique anatomy and condition. Each fusion nail also incorporates an internal compression device that allows the surgeon to control the compression between bone surfaces, thereby optimizing the conditions for fusion to occur. Wright estimates that over 30,000 hindfoot fusion procedures are performed annually in the United States, and over 50% are estimated to be treated with a fusion nail. With the expanding diabetic population, the number of patients requiring a nail option for salvage will continue to expand. The new VALOR® Hindfoot Fusion system will be made available immediately through Wright’s specialized Foot and Ankle sales force. For more information, contact Wright Medical Technology |
Monoblock Ceramic Technology
Amedica Corporation, a spinal and orthopedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has been granted a US patent covering its novel hip implant featuring a monoblock ceramic acetabular cup for use in articulating joints for total joint replacement. Currently under development, Amedica’s cup covered under this and other pending patents will be used as an ultra–low–wear–bearing component for motion-preserving implants. The technology allows Amedica to combine high-strength silicon nitride ceramic with an ultra–low–wear surface–bearing technology, along with a bone-contacting Bioactive™ surface designed for secure, long-term fixation. Amedica notes that this provides surgeons with wider design choices and flexibility to improve anatomic fit and function compared with currently available alternate bearing options. In addition to spinal implants, Amedica’s SiN materials have disruptive characteristics for hip and knee implant applications as well. The material is fracture-resistant; its articulating surfaces do not produce the wear debris that is linked to osteolysis-related reoperations. Additionally, the company notes that the Bioactive implants feature a hydrophilic surface and a conductive cancellous structure to enhance bone in-growth and attachment. For more information, contact Amedica |
Postmenopausal Osteoporosis Treatment
Amgen, Inc., announced that the US FDA has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or of patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is a 60-mg subcutaneous injection administered by a health care professional every 6 months. Prolia’s approval is based on a pivotal 3-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip, and nonvertebral fractures measured at 3 years.1 The pivotal 3-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that treatment with Prolia, administered as a 60-mg subcutaneous injection every 6 months, compared with placebo at 3 years resulted in: a 68% reduction in vertebral fractures (4.8% absolute risk reduction), a 40% reduction in hip fractures (0.3% absolute risk reduction), a 20% reduction in nonvertebral fractures (1.5% absolute risk reduction), and significant bone density increases at all key sites measured (8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck).2 The incidence of new spine fractures was 2.3% with Prolia vs. 7.2% with placebo. The incidence of hip fractures was 0.7% with Prolia vs. 1.2% with placebo. The incidence of non-spine fractures was 6.5% with Prolia vs. 8% with placebo. ProliaPlus™ is a multifaceted product support program designed to provide comprehensive assistance to health care providers, patients, and their caregivers to help facilitate access to Prolia for appropriate patients. ProliaPlus provides information and assistance on issues related to product insurance coverage to physician offices. Additionally, upon request, ProliaPlus will remind patients and providers about when the patient’s next dose is due, thus helping to support patient adherence to therapy. ProliaPlus will also have information on the availability of potential financial assistance programs. To review the Prolia prescribing information and REMS materials, visit www.amgen.com. For more information, contact References
Amgen Inc. |