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FDA OK's First Synthetic Implant

FDA OK's First Synthetic Implant
(Copyright DPC)

Thursday, 07 July 2016 01:27 PM

The U.S. Food and Drug Administration  (FDA) has approved its first synthetic cartilage device, which is designed to help people with painful arthritis in the big toe joint.

This is the first synthetic cartilage device to win FDA approval, according to Cartiva, the company that makes it.  The device, called the Cartiva Synthetic Cartridge Implant, is intended for use in the treatment of patients with painful arthritis at the base of the big toe, which is the most common arthritic condition in the foot.

A panel of the FDA recommended granting premarket approval to the device last April, after a study showed that implantation of the device helped relieve pain and improved function.

This type of arthritis occurs when the cartilage between the two bones, which make up the big toe, wears away, leaving the bones to rub together. A surgical procedure known as MTP Joint Fusion, which is the surgical fusing of the two bones together, is the current way the condition is treated.

The study involved 236 patients at multiple centers. According to the results, the 80 percent of the patients receiving the implant achieved pain relief, as well as function at 24 months, compared to 79 percent success rate in the group that underwent the fusion surgery, Medscape News reported.

The Cartiva implant group also saw a 93 percent reduction in pain, a 168 percent improvement in median function of sporting activities, and a 65 percent improvement in activities of daily living. The implant patients also experienced a 26 percent improvement in range of motion from baseline, the study found.

The implant procedure takes about 35 minutes and is performed on an outpatient basis. Unlike fusion therapy, patients may begin weight-bearing immediately as tolerated. They also must wear some type of cast or boot for 6-12 weeks, unlike implant patients, who must only deal with a dressing for several days, the company says.



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Arthritis of the big toe is a common, painful condition but now the FDA has approved a synthetic device to treat it.
FDA, arthritis, foot, synthetic, device, implant, foot
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2016-27-07
Thursday, 07 July 2016 01:27 PM
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