NEWLY AVAILABLE, NEWLY APPROVED


HIP-BEARING SYSTEM

DePuy Orthopaedics, Inc., has announced a new option for restoring hip mobility in patients who require total hip replacement: the Pinnacle® Acetabular Cup System AltrX™ hip bearing. This system provides advanced technology for recreating the natural ball-and-socket joint of the hip to help increase joint stability, range of motion, and longevity.1, 2

The AltrX polyethylene bearing is used with DePuy’s Pinnacle Acetabular Cup System — the only product available that provides surgeons with the option of choosing a polyethylene or metal insert for use with the same outer titanium cup that replaces the socket of the natural hip.

The Pinnacle cup exhibited 99% survivorship at 5 years and differences between patients, surgeons, femoral stems, head size, and articulation types did not affect survival.3

Key benefits are said to include significant wear reduction, with AltrX polyethylene liners achieving a 92% wear reduction over conventional polyethylene liners, while maintaining excellent mechanical integrity and oxidative resistance in laboratory simulations.4 In addition, the system is designed to provide optimized mechanical integrity by using an AltraLink™ material enhancement process. DePuy notes that AltrX liners achieve excellent mechanical toughness and oxidative resistance, which helps provide long-term durability of the implant. 5

For more information, contact,

DePuy Orthopedics
700 Orthopaedic Drive
Warsaw, IN 46582-3900
phone: (800) 366-8143
www.depuyorthopaedics.com

References

  1. "Data on file at DePuy Orthopaedics, Inc.
  2. A. Engh, et al. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non—cross-linked Enduron polyethylene liners. J Arthroplasty. 2006; 21 (Suppl. 2).
  3. Kindsfater K, Barrett W, Dowd J, Southworth C, Cassell M. Poster #P077, Midterm survival of the pinnacle Multi—Liner Acetabular Cup in a prospective multi-Center study, 2007. AAOS Annual Meeting.
  4. Data on file at DePuy Orthopaedics, Inc.
  5. Data on file at DePuy Orthopaedics, Inc.


ONCE-YEARLY TREATMENT FOR POSTMENOPAUSAL OSTEOPOROSIS

Reclast® (zoledronic acid) Injection has been approved by the US Food and Drug Administration as a once-yearly medicine for postmenopausal osteoporosis.

Efficacy and safety data from a 3-year Pivotal Fracture Trial showed that Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine, and the wrist, arm, leg, and rib. Novartis Pharmaceuticals points out that Reclast is the only treatment proven to reduce fractures across all of these key sites. In this study involving more than 7,700 women, Reclast reduced the risk of spine fractures by 70% and of hip fractures by 41%.1 The reduction in spine fractures was sustained over 3 years (60% in year 1, 71% in year 2, and 70% in year 3). Bone mineral density increased significantly in the spine by 6.7% and the hip by 6% in women taking Reclast compared with placebo.1

Osteoporotic fractures are responsible for an estimated 800,000 emergency room visits, 500,000 hospitalizations, 180,000 nursing home placements, and 2.6 million physician visits in the US each year, costing the healthcare system approximately 12.2 to 17.9 billion dollars annually.2

Reclast/Aclasta is approved in more than 60 countries, including the US, Canada, and the European Union for the treatment of Paget’s disease, the second most common metabolic bone disorder. Additional studies are ongoing to examine the use of Reclast to prevent fractures following a hip fracture in men and women, treatment of corticosteroid-induced osteoporosis, and male osteoporosis.

The active ingredient in Reclast is zoledronic acid, which is also available in a different dosage under the brand name Zometa® (zoledronic acid 4 mg) Injection for use in certain oncology indications.

To learn more, contact,

Novartis Pharmaceuticals
Corporation One Health PlazaEast
NJ 07936-1080
(888) 669-6682
For prescribing information, call 866-RECLAST (866-732-5278) or visit www.reclast.com.

References

  1. Black D, Delmas S, Eastell R, et al, for the HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. NEJM. 2007; 356(18):1809-1822.
  2. U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. 2004.