Integra LifeSciences, based in Plainsboro, N.J., has introduced its Paramount Pedicle Screw Fixation System for minimally invasive spine surgery. Integra acquired Paramount in September following the acquisition of certain assets from Mansfield, Mass.-based Innovative Spinal Technologies, Inc., which went bankrupt earlier this year.
According to the company, the system will be made available to a select group of surgeons following its introduction at NASS. A full launch of the Paramount system is planned for the first quarter of 2010, at which time the system will be released to surgeons throughout the United States.
One of the Paramount system’s unique features is its rod delivery system, wherein the rod is already attached to the screw head, helping to streamline a spinal fusion procedure and reducing the number of operative steps for the surgeon, according to company officials. The system also features a novel compression/distraction system and a robust rod reduction system. Additionally, the device’s screw delivery system uses a proprietary non-cannulated screw design with a K-wire guided tip for accurate screw placement and enhanced screw strength.
“The Paramount system provides surgeons with a unique and innovative solution for screw and rod delivery for spinal fixation,” said Dr. Ali Araghi of Texas Back Institute in Phoenix, Arizona and a former designer for Innovative Spinal Technologies.
A minimally invasive approach offers patients a safe, effective procedure with less blood loss and a shorter recovery time, Araghi added.
An estimated 450,000 thoraco-lumbar fusions will be performed in the United States in 2009 to treat spinal disorders. Surgeons typically perform these procedures using highly invasive open techniques. The company hopes products such as Paramount gives surgeons and patients a safe and effective minimally invasive option—resulting in quicker procedures, reduced blood loss, less tissue trauma and postoperative pain, and a shorter hospital stay.
“We’re very pleased that the addition of the Paramount system allows us to offer our current distributors and surgeon customers a minimally invasive approach to spinal fusions,” said Randy Theken, president of Integra Spine. “It also gives us an opportunity to further expand our distribution coverage throughout the United States.”
The Paramount system is distributed through the Integra Spine independent distributor network. Integra Spine is a provider of fusion implants and orthobiologics used in spinal surgery, and actively is developing motion preservation devices.