NEW YORK--(BUSINESS WIRE)-- Small Bone Innovations, Inc. (SBi) announced today that Humana, Inc., with nearly 11.3 million health plan members in the U.S. and UPMC Health, the second largest health plan in western Pennsylvania, with 1.2 million members, will each cover SBi’s STAR™ total ankle replacement system.
The STAR ankle is the only total ankle replacement system ever to be cleared through the FDA’s rigorous Premarket Approval (PMA) process. In the PMA process, the STAR ankle’s safety and effectiveness was compared with ankle fusion in a multi-year, multi-center, concurrently controlled, Investigational Device Exemption (IDE) study. The IDE study results, published in 20091, demonstrated STAR to be superior in efficacy and comparable in safety to fusion. The IDE and other study results also showed that the STAR ankle had better pain relief, greater clinical success, less blood loss and a shorter operating time than fusion.
The decisions by Humana and UPMC Health mean that STAR is available to approximately 100 percent or about 175 million of all privately insured health plan members in the U.S. This includes all major private U.S. health insurers including: all Blue Cross and Blue Shield Association member companies; Aetna; United Health Care; Humana; CIGNA; EmblemHealth; Health Net; Medical Mutual of Ohio; Coventry Health Care; Harvard Pilgrim Health Care; UniCare; Tufts Health Plan; LifeWise; QualChoice and others.
In addition, almost all of the 100 million eligible individuals covered by governmental insurance programs, such as Medicare, Medicaid and TRICARE, also have access to the STAR ankle, as do nearly all individuals covered by state workers' compensation programs.
SBi's reimbursement consultant, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), launched a program in late 2009 to inform and communicate to insurers the clinically proven benefits, superior comparative effectiveness versus ankle fusion and overall cost benefits of the STAR ankle. As a result, all major insurers have now revised their policies to provide coverage for an aggregate total of 275 million insured lives in the U.S.
Roger A. Mann2, MD, co-lead investigator in the IDE study and co-author of a recent long term study on STAR, said: "I believe that the reason why insurers have elected to cover the STAR ankle is the recognition of the implant’s superior effectiveness when compared to fusion. In addition, my studies of U.S. patients have demonstrated that the STAR implant is stable and functions for a long time – 91% survival after 9.1 years. The STAR can also be utilized in ankles with a high degree of deformity and is the only total ankle joint replacement with a mobile bearing that has FDA PMA approval for implantation "on-label" without the use of bone cement.”
1 Charles L. Saltzman et al: Prospective Controlled Trial of STAR™ Total Ankle Replacement Versus Ankle Fusion: Initial Results, Foot & Ankle International/Vol 30, No. 7/July 2009
2 Dr. Mann provides consulting services to SBi
3 Mann, J, Mann, R, Horton E: STARTM Long Term Result, Foot and Ankle International/Vol 32, No. 5/2011
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC (VB), the New York-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. SBi was the first company to focus purely on small bones & joints by integrating established companies and professionals in the field. It offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in the small bones & joints. SBi has facilities in New York, NY, Morrisville, PA, Péronnas, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in 46 countries.
For a notice on Forward Looking Statements and more information about SBi, please visit: www.totalsmallbone.com/us/press.php4 For product and patient information please visit: www.star-ankle.com and www.staranklereplacement.com.
Small Bone Innovations, Inc.
Varun Gandhi, 212-583-0370 ext. 2126
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