FDA clears Interventional Spine intervertebral body fusion device

26 January 2012 (Last Updated January 26th, 2012 18:30)

The US Food and Drug Administration has approved Interventional Spine's Opticage expandable intervertebral body fusion device, used for the treatment of degenerative disc disease (DDD).

Degenerative Disc Disease

The US Food and Drug Administration has approved Interventional Spine's Opticage expandable intervertebral body fusion device, used for the treatment of degenerative disc disease (DDD).

The Opticage expandable interbody is an integral part of the company's PerX360 System, which enables surgeons to perform a complete 360° percutaneous lumbar interbody fusion through a two 15mm incisions for the treatment of lumbar discogenic pain.

Professor David Greenwald of the Flagler Brain and Spine Institute in St Augustine, Florida, US, said that using Opticage expandable interbody, the channel for insertion is reduced and will help minimise tissue trauma and decrease the patient overall recovery times. "This is a significant milestone in the progression of making lumbar spinal fusion surgeries less invasive to patients.To my knowledge, no other interbody fusion cage in the market has the expansion capabilities of the Opticage,'' Greenwald added.

Interventional Spine CEO Walter Cuevas said they look forward to partnering with surgeons in the US to make the technology available to them in a manner that will benefit their patients.

Neurosurgery and Spine, Milwaukee, Wisconsin, US professor Cully White said the approval provides Interventional Spine with a unique technology, capable of transforming how lumbar spine fusion is performed, experiencing less pain, shorter hospital stays and better outcomes overall.

Based in California, US, Interventional Spine designs, develops and markets patented implantable devices for the spine that can be deployed via percutaneous techniques.

The Opticage expandable intervertebral body fusion device is an addition to the company's product portfolio including Perpos PLS system, Perpos percutaneous cervical system, PDS system and Renew Allograft. The Perpos percutaneous cervical system comprises a 3.8mm CS facet compression device which is indicated for the treatment of spondylolisthesis, spondylolysis and DDD. The Perpos PLS system is a complete set of instruments engineered for percutaneous implantation of the Bone-Lok implant that enables single or multilevel bilateral fixation without rods and screws.

Image: Micrograph of a fragment of a resected degenerative vertebral disc, showing degenerative fibrocartilage and clusters of chondrocytes. Photo: Nephron.