US FDA Clears SpineGuard to Market DSG Integration Module for Making Pedicle Screws "Smart".
M2 PHARMA-January 17, 2017-US FDA Clears SpineGuard to Market DSG Integration Module for Making Pedicle Screws "Smart"
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- French medical device company SpineGuard has received 510(k) clearance from the US Food and Drug Administration for its new DSG (Dynamic Surgical Guidance) integration module to be used in combination with Zavation's spinal fusion system to make its pedicle screws "smart," the company said.
According to the company, the DSG-enabled screw is the unique combination of a bipolar sensor and a pedicle screw in just one device.
This technology offers surgeons real-time guidance and the ability to insert the screw directly into a vertebra without drilling a pilot hole. In minimally invasive surgery, it also obviates the need for a k-wire.
The DSG sensor differentiates various tissue types (cancellous bone, cortical bone, blood and soft tissues) based on the analysis of the local electrical conductivity.
Real-time feedback informs the surgeon of changes in tissue type by an audio signal varying in pitch and cadence. This in turn alerts the surgeon of potential breaches during pedicle screw placement and allows for screw redirection.
The outcome is a single-step pedicle screw insertion with a high degree of accuracy, reduced radiation exposure and streamlined surgical steps resulting in potential time and cost savings.
During the recent annual meeting of the North American Spine Society in Boston, SpineGuard received an award from Orthopedics this Week recognizing the DSG Screw as one of the BEST new spine care technologies.
Another DSG-enabled SmartScrew co-developed with Neuro France Implants (La ville-aux-Clercs, France) is currently in alpha launch in Europe with seven surgeons having started to use the system.
Co-founded in 2009 in France and the USA by Pierre Jerome and Stephane Bette, SpineGuard's mission is to make spine surgery safer by bringing real-time digital technology into the operating room.
Its primary objective is to establish its proprietary DSG (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries.
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|Date:||Jan 17, 2017|
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