Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone & joint sector of the orthopedics industry, announced today that an ‘Approvable Letter’ has been received from the U.S. Food and Drug Administration (FDA) for the Scandinavian Total Ankle Replacement system (S.T.A.R. Ankle).
The Approvable Letter states that the FDA has concluded its review of the S.T.A.R. Ankle PMA application. It has determined that the device can proceed through the final steps of the PMA process as an alternative to fusion for replacing an ankle joint deformed by rheumatoid arthritis, primary arthritis or post-traumatic arthritis.
The S.T.A.R. Ankle implant is designed to mimic normal ankle movement and function through its three functional components. The tibial plate component, which attaches to the tibia, and the talar component, which attaches to the talus, are both made of a highly polished cobalt-chromium-molybdenum alloy. Both the upper tibial surface and the lower talar surface are coated with a titanium porous plasma spray coating to help enhance bone incorporation into the implant. The third component, the mobile bearing, is placed between the tibial and talar components and is made from ultra high molecular weight polyethylene (UHMWPE). The S.T.A.R. Ankle is intended for uncemented use, allowing for better bone ingrowth and increased preservation of bone. The 3-piece system is designed to restore anatomic form, preserve near normal motion in most planes, and realize near full-range motion.
The S.T.A.R. Ankle has a 30 year development history beginning with the development of the first generation S.T.A.R. prosthesis by Hakon Kofoed, MD*, in 1978. In 1986, polyethylene was added to the S.T.A.R. Ankle design to create the second generation of the prosthesis. Then in 1990, the third generation of the S.T.A.R. Ankle was created when a titanium plasma spray coating was applied to the implant’s tibial and talar components.
A U.S. Investigational Device Exemption (IDE) Clinical Trial of the S.T.A.R. Ankle was initiated in 2000 as a prospective, multi-center, concurrently controlled study. The study followed patients for a minimum of 24 months. The two principal investigators were Roger A. Mann, MD**, of Oakland Bone & Joint Specialists, Oakland, CA and consulting surgeon at the Steadman-Hawkins Clinic, Vail, CO and Michael J. Coughlin, MD**, of the Idaho Orthopaedic Institute at St. Alphonsus Regional Medical Center, Boise, ID. S.T.A.R. Ankle patients were enrolled at ten sites in the Pivotal Trial and additional patients were enrolled and followed-up during the “Continued Access” phase of the clinical study at these same ten sites.
The S.T.A.R. Ankle Pre-Market Approval (PMA) application was accepted for filing by the FDA in March, 2006. An FDA Advisory Panel recommended approval on April 24, 2007.
On February 3, 2009, SBi announced that it had completed the acquisition of Link America, Inc., d/b/a Link Orthopaedics, the S.T.A.R. Ankle system, and certain assets related to the S.T.A.R. Ankle from DERU GmbH and Waldemar Link GmbH & Co. KG of Hamburg, Germany. The value of the transaction has not been disclosed.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “This Approvable Letter is one of the final steps toward providing U.S. patients with a proven, advanced technology that we believe will change the standard of care from fusion to total ankle arthroplasty. The third generation of S.T.A.R. Ankle has been used clinically since 1990 in more than 25 other countries with over 14,500 implantations. It is anatomically designed to alleviate pain through a less invasive, bone-conserving surgical procedure. The S.T.A.R. Ankle surgical procedure minimizes bone resection and is therefore a resurfacing-type approach.”
James K. DeOrio, MD**, Associate Professor in Orthopedic Surgery and a specialist in lower limb reconstruction at Duke University Medical Center, Durham, NC, said: “As an active participant in the United States S.T.A.R. Ankle Investigational Device Exemption (IDE) clinical study and a total ankle implant specialist, it is clear that the 3-part, non-constrained, mobile bearing design represents a viable option not only to arthrodesis, but also to all other ankle treatment or replacement options available to me.”
“The non-restrained mobile bearing design is now state-of-the-art worldwide, and those of us in the S.T.A.R. Ankle study can now look forward to sharing the benefits of this successful technology with our colleagues and their patients throughout the U.S.,” he added.
Massimo Calafiore, Former President of Link Orthopaedics, said: “SBi is an excellent partner in bringing this technology to the U.S. market and is ideally suited to take advantage of the substantial promise of the S.T.A.R. Ankle.”
Currently, only two-piece ankle replacement devices requiring the use of bone cement are available in the U.S. as alternatives to fusion. Fusion of the ankle joint significantly reduces mobility and may lead to other musculoskeletal pathologies. Upon final PMA approval of the S.T.A.R. Ankle from the FDA, the device would be the first and only FDA-approved, uncemented, mobile-bearing, total ankle replacement prosthesis available to patients in the U.S.
With the receipt of the Approvable Letter from the FDA, one of the final steps in the approval process is the satisfactory completion of a quality system inspection by the FDA at Waldemar LINK GmbH & Co. KG. Waldemar LINK will continue to manufacture the S.T.A.R. Ankle at its manufacturing facility in Hamburg, Germany. SBi currently expects the inspection of LINK’s manufacturing facility to be completed in 2009.
Thomas A. Crowley, President of SBi, noted that: “A study conducted among attendees at the 2008 24th Annual Summer Meeting of the American Orthopedic Foot & Ankle Society in Denver, CO (June 26-28), found that the key criteria for adoption of a total ankle replacement (TAR) prosthesis were FDA PMA-approved TAR prosthesis, peer-reviewed articles and the availability of long-term clinical data.”
“S.T.A.R. Ankle meets all the criteria for rapid adoption of total ankle replacement (TAR) prosthesis in the U.S. The effect of a final FDA approval order for the S.T.A.R. Ankle has long been anticipated by surgeons specializing in TAR treatment and their patients. In addition, our training curriculum, developed in consultation with several surgeons who participated in the U.S. clinical trial, will help accelerate acceptance in the U.S.,” Mr. Crowley added.
Florian Kemmerich, President of SBi International, said: “We expect the final FDA PMA approval order and subsequent publication of IDE clinical data for S.T.A.R. Ankle to accelerate growth of clinical use of the S.T.A.R. total ankle replacement in countries outside of the U.S. where it has long been used, as surgeons view this important clinical milestone positively.”
*Surgeons quoted in this release are or previously were contracted by SBi for product development work.
**Surgeons quoted in this release provide consulting services to SBi.
Source: Small Bone Innovations