New Total Ankle Replacement Systems Earns FDA Approval

People who suffer from arthritic or deformed ankles resulting in a loss of range of motion in the joint now may have a new surgery option.

The Food and Drug Administration has just approved a first-of-its-kind total ankle replacement system made by Small Bone Innovations Inc. of Morrisville, Pa. The medical device, called the Scandinavian Total Ankle Replacement System, or STAR for short, uses bearings and a flexible plastic surface to replace a deformed or damaged ankle.

Arthritis and injuries can destroy the cartilage that cushions the ankle bone, allowing the joint to grind and cause severe pain. In some cases, a total ankle replacement may be necessary.

The STAR system is an alternative to traditional ankle-replacement procedures, in which the tibia (shin bone) is fused to the talus bone in the ankle to stabilize the joint. The surgery substantially reduces the ability of the foot to move up and down.

The STAR system can provide more rotation of the ankle and better movement of the ankle joint, officials said. It is designed to more closely imitate the natural movement of the ankle, according to an FDA official.

Other fixed-bearing ankle devices have already been approved by the FDA. Those devices use an articulating surface which is molded, locked, or attached to a metal component to stabilize the ankle.

A two-year clinical study of the STAR system found that it produced no more side effects, surgical interventions, or major complications compared to traditional ankle fusion surgery, the FDA said.

The maker of the STAR system will for the next eight years evaluate the safety and effectiveness of the device as part of the FDA approval.

Source: attorneyatlaw.com