The PediGuard Bone-Monitoring Device by SpineGuard is a handheld, wireless device that can detect possible vertebral cortex perforation during pedicle preparation for screw placement.
The device can alert surgeons prior to a breach, and it has been used in more 25,000 surgeries worldwide.
1. SpineGuard recently announced that its PediGuard platform has been adopted by the Children's Hospital of New Orleans (La.), the 20th teaching institution to have done so in the United States.
"An obvious advantage of the PediGuard technology is that there is no radiation required during pedicle screw placement. There is increasing concern about the long-term consequences of medical treatment based radiation exposure. The dosage is cumulative, and has been shown to significantly affect the lifetime risk for cancer," said Andrew G. King, MD, orthopedic surgery department chair, LSU Health Sciences Center in New Orleans and orthopedic surgeon at Children's Hospital of New Orleans. "For this reason alone, pedicle screw placement navigated by sensors in the pedicle probe is gaining popularity, and with technological advances, should become standard."
2. The scientific principle of PediGuard is based on the electrical conductivity of tissue. The device alerts surgeons prior to breach during pedicle preparation by accurately analyzing the electrical conductivity of the surrounding tissues. The PediGuard technology is available to surgeons in numerous forms: Classic PediGuard, Curved PediGuard and Cannulated PediGuard.
3. The PediGuard device has undergone clinical trials to prove its efficacy. Recently, the device successfully identified an impassable cortical pedicle isthmus in 34 pedicles in a prospective clinical analysis of 50 patients with cervical spine disease, according to data presented by principal investigator Heiko Koller, MD, PhD, at the 5th Annual Meeting of the Cervical Spine Research Society-Asia Pacific Section in Ho Chi Minh City, Vietnam.
The decision to stop pedicle screw tract preparation based on a signal from the PediGuard device in 34 pedicles was later confirmed appropriate, based on analysis of postoperative CT scans.
4. SpineGuard announced that it sold 6,308 of its PediGuard units in 2013, as compared to the 5,225 units sold for the full year 2012. The company recorded a net loss of $5.8 million for the full year 2013, and revenue for the fiscal year 2013 was $7.6 million. The company also received approval in Russia for the entire PediGuard bone-monitoring platform.
5. SpineGuard is a public company and was founded in 2009 with the aim of commercializing and reaching the full market potential of the PediGuard technology. The original inventors of the technology are Ciaran Bolger, MD, PhD, and Maurice Bourlion, PhD. The company continues to grow and look for new applications for its PediGuard platform.
More Articles on Devices:
5 Key Results: LDR's Mobi-C Artificial Disc Replacement vs. ACDF
FDA Clears AccelSPINE's Next Generation Minimally Invasive Spine System
Global Medical Device Market to Grow at 6.2% Annually Until 2018