Fusion System for Lumbar Spine Approved
The new AxiaLIF 2L, manufactured by TranS1, Incorporated, received marketing clearance for U.S. sales last week. The new device is indicated to treat patients with degenerative disc disease of the lumbar spine, specifically L5-S1 and L4-L5.
The AxiaLIF 2L is a percutaneous lumbar fusion system that treats two levels of lumbar discs in one device. The device allows surgeons to complete disc fusion at multiple levels without causing structural damage to the adjacent soft tissue structures that provide key support.
The device is implanted through an access point that is approximately an inch and a half long. Studies completed with the device indicate improvements for patients with respect to functional capacity as well as long term reduction in radiculopathy. Another benefit is decreased length of hospital stay following the procedure.
The new device significantly expands the number of patients who are eligible to be treated with disc fusion. This represents a significant opportunity for TranS1 to increase revenue. The company already has two devices on the market designed for fusion of one disc level, the AxiaLIF 360 and the AxiaLIF. One device to treat fusion of two levels is already available in the European market.
The company is still crafting plans for the marketing effort. The company is dedicated to the development of devices to support treatment of degenerative disc disease of the lumbar spine.
May 5, 2008 Related topics: Product Approval & Certification, Surgery, Psychiatry & Neurology, Orthopedic