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Small Bone Innovations plans to acquire STAR total ankle replacement system

Small Bone Innovations : 30 January, 2008  (New Product)
Small Bone Innovations (SBi) has entered into definitive agreements to acquire Link America d/b/a LINK Orthopaedics, The Scandinavian Total Ankle Replacement system, known as the STAR Ankle.
The deal also includes certain assets related to the STAR Ankle from Waldemar Link of Hamburg, Germany.

Outside North America, both Waldemar Link and SBi are committed to continue to provide the highest level of service to all customers throughout the existing global distribution network.

The STAR Ankle is manufactured by Waldemar Link, and was first designed as an anatomic non-constrained, resurfacing prosthesis in 1978 by Hakon Kofoed, MD, president elect of the European Foot and Ankle Society and associate professor of orthopaedics at the University of Copenhagen, Denmark.

It was designed to be less invasive, bone conserving and tissue preserving and a significant improvement over the prostheses of the early 1970s that required resection of large portions of bone and sacrificed soft tissue integrity.

Anthony G Viscogliosi, chairman, CEO and president of SBi, said: “The current version of the STAR Ankle has been used clinically since 1990 throughout the world in 27 countries with over 10,000 implantations. There have been at least 30 clinical papers written and countless presentations given over the past three decades on the STAR Ankle.”

According to Viscogliosi, there are an estimated 65,000 ankle procedures done in the USA annually, including an estimated 18,000 arthrodeses and ankle replacement procedures for which the STAR Ankle could be used in properly selected patients, if and when it receives FDA approval.

A US IDE (Investigational Device Exemption) Clinical Trial was initiated in 2000 as a prospective, multi-centre, concurrently controlled study, and remains ongoing while FDA completes its review of the PMA (Pre-Market Approval) application for the STAR Ankle. SBi believes this represents the most rigorous study ever undertaken in the USA for an ankle joint replacement prosthesis.

The study follows patients for a minimum of 24 months. The two principal investigators were Roger Mann, MD and Michael Coughlin, MD. There were 10 sites that enrolled STAR Ankle patients in the Pivotal Trial and a larger group in the Continued Access study.

The FDA accepted the PMA application for filing in March 2006. An FDA Panel recommended approval with conditions on April 24, 2007.

SBi believes that, if and when the device receives final approval by the FDA, the device would be the first and only FDA approved, non-cemented mobile bearing total ankle replacement prosthesis available to patients in the USA.

“Currently, there are no FDA approved mobile bearing ankles for use in the USA. The only total ankle replacements available in the USA are of the two-part, constrained, fixed bearing design that do not restore full, natural motion, and in order for those ankles to be used in accordance with FDA approved labelling, they should be fully cemented in place,” Viscogliosi said.

Massimo Calafiore, president of Link America, said: “We are very pleased to have entered into this agreement with SBi. Throughout the process SBi demonstrated focus, continuing enthusiasm and commitment to this opportunity.”

Andy Greenberg, managing director of Link America, said: “The US IDE Clinical Trial has required a tremendous decade long commitment from all the surgeons and staffs involved - who agreed to participate for no other reason than to attempt to improve the lives of patients. Helmut D Link, chairman of Link America, and I want to thank everyone personally for their efforts.”

The inventor of the STAR Ankle, Dr Kofoed, noted: “The experience from the 1970s showed significant individual differences between a patient’ s ankle pathologies and that patients need more than a 2-piece device. A 3-piece mobile-bearing ankle prosthesis allows the ankle to find its own direction and accommodate patient variability.”
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