This article is more than 5 years old. Information may no longer be current.
FDA advisory panel recommends ankle replacement system for premarket approval
A draft statement of the approval cites five conditions including postapproval study and patient education.
Click Here to Manage Email Alerts
The Orthopaedic and Rehabilitation Devices advisory panel to the FDA voted 4-2 yesterday to recommend the Scandinavian Total Ankle Replacement System be approved with conditions.
|
|
"This is a culmination of a 7-year premarketing approval (PMA) study," Michael J. Coughlin, MD, a co-investigator for the Scandinavian Total Ankle Replacement System (STAR) [Link Orthopaedics] project, told Orthopedics Today in an interview.
Coughlin and colleagues presented 2-year follow-up data for a trial comparing total ankle arthroplasty using the STAR system to ankle arthrodesis. The results showed "diminished pain, improved function and continued range of motion with the three-part total ankle that includes a mobile bearing," Coughlin said.
At 24 months follow-up, the patient success rate was 13.7% for controls vs. 45.1% for the STAR group. Also, the efficacy success rate was 14.9% for controls vs. 58.5% for the STAR group and the safety success rate was 82.7% for controls vs. 71.1% for the STAR group, according to the executive summary provided to the committee by Link Orthopaedics.
At 12 months, Buechel-Pappas scores averaged 65.9 points for controls vs. 80.7 points for STAR patients. At 24 months, scores averaged 69.7 points for controls and 81.6 points for STAR patients, according to the executive summary.
The executive secretary of the panel, Ronald P. Jean, PhD, told Orthopedics Today that a draft statement of the conditions for approval includes the following:
- a long-term postapproval follow-up study;
- pre-clinical testing to support the proposed weight limit;
- an update to the surgical manual;
- patient education explaining risks in laymen's terms in the package insert; and
- excluding severe deformity and primary arthrosis from the device's indications.
Steven D.K. Ross, MD, president-elect of the American Orthopaedic Foot and Ankle Society and an Orthopedics Today editorial board member, said that the organization's members welcomed the panel's recommendation.
"I think once approved, [the STAR] would allow orthopedic surgeons to have another option for the treatment of patients with severe ankle arthritis," Ross told Orthopedics Today. "[We're] all pleased that the safety and effectiveness data that were presented were found to be acceptable and that the benefits to the patients have been found to outweigh the potential risks."
For more information:
- Michael J. Coughlin, MD, can be reached at St. Alphonsus Regional Medical Center, 901 N. Curtis Road, Boise, ID, 83706; 208-377-1000; footmd@aol.com. He is a co-investigator for the STAR system and is a paid consultant for Link Orthopaedics. He has no equity in the company and received no grants or royalties regarding the STAR or any other product from Link.
- Ronald P. Jean, PhD, executive secretary of the Orthopaedic and Rehabilitation Devices panel, can be reached at Center for Devices and Radiological Health, FDA, 9200 Corporate Blvd., Rockville, MD, 20850; 240-276-3676; ronald.jean@fda.hhs.gov.
- Steven D.K. Ross, MD, can be reached at the American Orthopaedic Foot and Ankle Society, 6300 N. River Road, Suite 510, Rosemont, IL 60018; 1-800-235-4855; sdross@uci.edu. He has worked on a total ankle arthroplasty design but has no product, and is not a consultant for a company.