STAR™ Total Ankle Replacement Passes 5,000 Implant Milestone In The US

MORRISVILLE, Pa., June 26, 2013 /PRNewswire/ -- Small Bone Innovations, Inc. (SBi) announced today that surgeons in the US have now implanted more than 5,000 STAR Total Ankle Replacement Systems since receiving FDA approval in May 2009. 

STAR is the only three-piece, mobile-bearing, non-constrained total ankle replacement system approved for uncemented use through the FDA's rigorous Premarket Approval (PMA) process.  All other total ankle replacement systems available in the US have FDA 510(k) marketing clearance and must be implanted using bone cement.

The Investigational Device Exemption (IDE) study results supporting the PMA demonstrated STAR to be superior in efficacy and comparable in safety to fusion.  The IDE and other subsequent studies have also shown that the STAR ankle provides better pain relief, greater clinical success, less blood loss and a shorter operating time than fusion.

The company believes STAR leads the market in terms of volume of clinical literature - 119 published clinical papers worldwide (29% of all Total Ankle Arthroplasty papers).  Furthermore, the company believes that STAR is the only total ankle replacement system with published long-term US clinical results with 91% survivorship at an average follow-up of 9.1 years and 92% patient satisfaction¹.   

Roger A. Mann², MD, co-lead investigator in the IDE study commented: "The distinct advantage of the STAR ankle has always been its preponderance of clinical evidence.  Patients want access to innovative, life-changing technologies.  STAR's clinical data gives surgeons the confidence to provide patients with a technology proven to be more effective, but just as safe as the fusion alternative.  It has been a personal pleasure for me to see STAR improve quality of life for so many of my own patients."

Michael P. Simpson, President & CEO of SBi added: "The 5,000 implant mark is a huge milestone on the road to offering both patients and providers access to an innovative technology with a history of clinical success.  The fact that STAR has grown to become the market leading total ankle replacement system signals its superiority in addressing a rapidly growing, unmet clinical need." 

¹ Mann, J, Mann, R, Horton E: STARTM Long Term Result, Foot and Ankle International/Vol 32, No. 5/2011
² Dr. Mann provides consulting services to SBi

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 Morrisville, PA, Peronnas, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in more than 40 countries.

Forward-looking statements

This news release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995.  Readers are cautioned not to place undue reliance on these forward-looking statements.  Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting SBi's business including increased competition; the ability of SBi to expand its operations and to attract and retain qualified professionals; technological obsolescence; general economic conditions; and other risks.

Contact:
Varun Gandhi
Small Bone Innovations, Inc.
P: (215) 428-1791
E: [email protected]

SOURCE Small Bone Innovations, Inc.