Amedica gets FDA approval for expanded aleo(R) II Lateral Lumbar Interbody Fusion Device

24 August 2016 (Last Updated August 24th, 2016 18:30)

US-based biomaterial company Amedica has obtained the US Food and Drug Administration (FDA) approval for its expanded Valeo II Lateral Lumbar sizes.

US-based biomaterial company Amedica has obtained the US Food and Drug Administration (FDA) approval for its expanded Valeo II Lateral Lumbar sizes.

The Valeo II LL interbody fusion device is composed entirely of Amedica's patented medical grade silicon nitride ceramic which is considered an ideal material for fusion by virtue of its inherent osteoconductivity, anti-infective properties, bone-like imaging (artifact-free and radiotranslucent), and strength.

It has been designed for intervertebral body fusion of the spine in skeletally mature patients and can be used with autograft to facilitate fusion.

"The minimally invasive nature of the procedure provides patients with benefits such as less blood loss, smaller incisions and shorter hospital and intraoperative times."

The device features second generation instrumentation with a view to improve patient safety and ease of use for the surgeon.

Amedica chairman and CEO Dr Sonny Bal said: "I am delighted to announce the recent FDA clearance of our expanded silicon nitride lateral lumbar implant offerings.

"It is 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 expanded Valeo II Lateral Lumbar sizes will allow the device to be used across a wider range of the patient’s anatomy, while offering greater stability as the shape of the implant distributes its weight over a larger area.

The interbody fusion device is fitted with a range of features which are the teeth to offer expulsion resistance; knurls to add stability; a threaded insertion feature for precision implant control, and two increased central cavities for optimal bone graft packing.