Is prodisc FDA approved?

Is prodisc FDA approved?

The prodisc first received FDA approval in 2006. In an April 4, 2020 press release, the company said they are now the only company with an FDA approved lumbar TDR device that has been clinically reviewed and found safe and effective for two level use.

How long does it take to recover from disc replacement surgery?

Research shows that disc replacement surgery recovery time is between three and five weeks. However, the recovery time depends on different factors, such as the patient’s condition and overall health status, symptoms’ severity, age, and the clinic where the surgery is performed.

Is disc replacement considered major surgery?

Lumbar disk replacement is generally seen as an alternative to the more common spinal fusion surgery. Fusion permanently joins 2 vertebrae together. Lumbar disk replacement is a major surgery that requires general anesthesia and a hospital stay.

What is Pro Disc L total disc replacement?

The most studied and clinically-proven total disc replacement technology in the world is now the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine. NEW! The pro disc L Total Disc Replacement system now has a greater selection of endplates available.

What are the components of the Pro Disc ® L?

The pro disc ® L consists of three implant components; two metallic (cobalt-chrome) endplates and a plastic (ultra-high molecular weight polyethylene) inlay. This approval expands the indication for use of the pro disc ® L to include treatment of up to two consecutive lumbar spinal sections (levels) from L3-S1.

What is Pro-Disc L?

The discs in conjunction with the vertebral joints facilitate motion by turning, stretching and bending of the neck. pro disc L has a very long clinical history (25+ years) and has been widely used throughout the world.

How effective is Pro Disc L for degenerative disc disease (DDD)?

A clinical study of the device showed that the pro disc ® L was at least as effective as spinal fusion for treating patients with Degenerative Disc Disease (DDD) for at least five years past treatment. Patients with two-levels of pro disc ® L experienced a lower rate of secondary surgery than two-level spinal fusion patients.