Amedica (AMDA) Announces Receipt of FDA Clearance for Expanded Valeo II Lateral Lumbar Sizes
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Amedica Corporation (Nasdaq: AMDA) announced the U.S. Food and Drug Administration (FDA) clearance of expanded Valeo II Lateral Lumbar sizes. The additional sizes of the Valeo II LL interbody fusion device will be commercially available August 29, 2016.
The Valeo II LL interbody fusion device is made entirely of Amedica's proprietary medical grade silicon nitride ceramic -- an ideal material for fusion, due to its inherent osteoconductivity, anti-infective properties, bone-like imaging (artifact-free & radiotranslucent), and exceptional strength. The system includes second generation instrumentation to improve patient safety and surgeon ease of use.
"I'm delighted to announce the recent FDA clearance of our expanded silicon nitride lateral lumbar implant offerings," said Dr. Sonny Bal, Chairman and Chief Executive Officer. "It's estimated that lateral lumbar procedures will remain one of the fastest growing interbody fusion segments over the next five years. The minimally invasive nature of the procedure provides patients with benefits such as less blood loss, smaller incisions and shorter hospital and intraoperative times. We believe these clinical benefits, coupled with our unique silicon nitride biomaterial will lead to an improved continuum of care for individuals."
The recently cleared sizes allow for greater accommodation for a wide range of patient anatomies as well as greater stability as the shape of the implant distributes weight over a larger surface area. The design of the interbody fusion device consists of aggressive teeth for expulsion resistance, knurls for added stability, a threaded insertion feature for precision implant control, and two central cavities maximized for optimal bone graft packing.
The Valeo II LL is indicated for intervertebral body fusion of the spine in skeletally mature patients and is designed for use with autograft to facilitate fusion. Additional information about Amedica's complete line of products can be found at www.amedica.com.
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