NEW YORK--(BUSINESS WIRE)--Small Bone Innovations, Inc. (SBi) announced today that LifeWise health plans in Washington State, Oregon and Alaska, covering 1.6 million members, have revised their coverage policies to cover the company’s STAR™ total ankle. The STAR ankle is the only total ankle replacement system (TAR) cleared through the U.S. Food and Drug Administration’s (FDA) rigorous pre-market approval process (PMA).
LifeWise offers plans under the brand name Premera Blue Cross in Alaska and Washington State, as well as its LifeWise Health Plans of Oregon and LifeWise Health Plans of Washington.
LifeWise’s policy changes extend STAR ankle coverage to more than 92 percent or 161 million privately insured health plan members in the U.S. This includes major private insurers such as all BlueCross and BlueShield Association member companies, Aetna, Cigna, Coventry and others. 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 well as most individuals covered by state workers’ compensation programs. This brings the total covered lives for TAR in the U.S. to 261 million.
The STAR ankle’s safety and effectiveness was compared with ankle fusion in a multi-center, multi-year, Investigational Device Exemption (IDE) study. The study results, published in 2009, supported the only PMA order to be issued by the FDA for a total ankle joint replacement by demonstrating the STAR to be superior in efficacy and comparable in safety to fusion.
Dr. Jeffrey Christensen¹, a Seattle-based Podiatric Foot & Ankle Surgeon said: “The latest generation of TAR systems are providing a high level of functionality as well as eliminating or minimizing pain – leading to longer term benefits that patients, as well as insurers, can recognize. Should these early surgical benefits last up to ten years or more, which STAR has demonstrated, we could see total ankle technology replacing fusion as the gold standard for treating mid-to-late stage ankle arthritis.”
¹ Dr. Christensen is paid consultant to SBi - providing education services.
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, Bourg-en-Bresse, 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: http://www.totalsmallbone.com/us/press.php4.
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