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(Medical-NewsWire.com, October 06, 2012 ) Boca Raton, FL --- The STAR ankle is the only total ankle replacement system approved through the US Food and Drug Administration's (FDA) rigorous Premarket Approval (PMA) process. In the PMA process, the STAR ankle's safety and effectiveness was compared with ankle fusion in a multi-center, multi-year, 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 subsequent studies show that the STAR ankle has better pain relief, greater clinical success, less blood loss and a shorter operating time than fusion.
The 21st Century Health broadcast features interviews with Thomas O. Clanton MD, an internationally renowned orthopaedic surgeon and the head of the Foot & Ankle practice at the Steadman Clinic in Vail, Colorado and SBi’s Founder and Executive Chairman, Anthony G. Viscogliosi.
J.L. Haber, Vice President of Programming at Multi Media Productions, Boca Raton, FL, the segment producer, said: “In our search for companies that are truly making a difference in their industry and we are pleased to report that 21st Century Health wishes to broadcast the STAR total ankle replacement story alerting the many thousands of patients suffering from ankle arthritis.”
The STAR ankle news segment and other programs can also be viewed immediately on SBi’s YouTube channel: http://www.youtube.com/user/SmallBoneInnovation
For Airing Schedule, please click the following link: http://21cbtv.com/clearance-report/21cb2305-fbn.pdf
¹ Charles L. Saltzman MD et al: Prospective Controlled Trial of STAR™ Total Ankle Replacement Versus Ankle Fusion: Initial Results, Foot & Ankle International/Volume 30, No. 7/July 2009
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 41 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 on the STAR ankle please visit: www.star-ankle.com and www.staranklereplacement.com
Contact: Varun Gandhi Small Bone Innovations, Inc. P: 212.583.0370 ext. 2126 E: vgandhi@totalsmallbone.com
MultiMedia Productions
Gila Stern
561-988-9449 x269
gstern@mmpusa.com
Source: EmailWire.Com
Source: EmailWire.com
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