products - agilus™
Agilus™ is a highly purified hyaluronan, also known as hyaluronic acid (HA) or sodium hyaluronate. HA is a naturally occurring substance found in synovial fluid, a clear, viscous (thick) fluid with a stringy consistency that acts as a lubricant, reducing the friction between articular cartilage and other tissues in joints, and as a shock absorber during movement. In osteoarthritis, there is a decrease in the hyaluronan concentration in the synovial fluid, reducing its viscosity (thickness) and elasticity (resilience). Supplementing the joint's naturally-produced hyaluronic acid with intra-articular injections of HA, a procedure known as viscosupplementation, may restore the synovial fluid's ability to cushion, lubricate and protect joints damaged by osteoarthritis. Viscosupplementation has been shown to relieve pain in patients with knee osteoarthritis who cannot get relief from or are unable to tolerate pain medication.
Agilus (1% sodium hyaluronate) is manufactured in the United States through a proprietary process. This process, free of any animal proteins, results in a finished product of high purity. Unlike the majority of hyaluronic acid products currently marketed in the United States for osteoarthritis of the knee, Agilus is not made from rooster combs, eliminating the potential for an allergic response in patients with sensitivity to avian products (such as feathers, eggs or poultry). Agilus was specifically developed to optimize performance in mid-size and small joints. Its combination of purity, high molecular weight and ease of injection through a tiny needle, could potentially make it ideal for joints such as the foot and hand.
Clinical Trial
Agilus is currently being evaluated in a multicenter clinical research study.
The objective of the study is to compare the safety and effectiveness of Agilus
to a saline injection (placebo) in the treatment of ankle osteoarthritis (OA).
The clinical trial is a prospective, randomized, double blind, controlled
clinical trial enrolling approximately 380 patients at 20 sites throughout the
United States. The active treatment group will receive three (3) weekly
intra-articular injections of Agilus and the control group will receive three
(3) weekly intra-articular injections of normal saline. For more information
on this clinical study or to see if you are eligible to participate, please
visit www.anklestudy.com.
Caution: Investigational device. Limited by Federal (or United States) law to investigational use.