Mexico OKs New Instrument from SpineGuard; Firm Also Nabs U.S. Patent for Pedicle Screw
SpineGuard has received a pair of significant nods from international regulatory and legal bodies recently.
The company got the OK from from Mexico’s healthcare regulatory authority, COFEPRIS, to sell its Cannulated PediGuard device in Mexico. SpineGuard previously received clearance for its Classic PediGuard device. The Classic, Curved and Cannulated PediGuard devices (all of which have CE mark and U.S. Food and Drug Administraion clearance) are single-use drilling instruments to secure the pilot hole in which to place a pedicle screw.
“PediGuard’s guidance allows us to place pedicle screws in an optimal way, designed to ensure superior outcomes for our patients,” said Ricardo Flores Escamilla, M.D., Neurosurgeon, Chief of Neurosurgery Service, Hospital Almater Mexicali, Baja California, Mexico.
The use of minimally invasive surgical (MIS) techniques provides substantial benefits for patients, including shorter surgery times and quicker recovery. However the procedures also often result in the increased use of fluoroscopy by surgeons to compensate for their lack of direct visual landmarks and tactile feel, exposing operating room (OR) teams to excessive doses of radiation.
Surgeons’ greater reliance on fluoroscopy during those procedures exposes the OR team to dangerous radiation. According to statistics cited by SpineGuard, the average spine surgeon will receive the maximum allowable lifetime exposure of radiation for workers within 10 years of practice, and the radiation exposure in spine surgery has been found to be 10 to 12 times greater than the radiation exposure during other fluoroscopically assisted non-spinal musculoskeletal procedures.
“The regulatory approval of Cannulated PediGuard expands our product offering in the important market of Mexico, where minimally invasive spine surgery is progressing rapidly. Cannulated PediGuard is designed to facilitate and secure this challenging procedure, providing real-time information that empowers spine surgeons to accurately place pedicle screws while avoiding cortical breaches and reducing their exposure to radiation as a result of less dependence on fluoroscopy,” said Pierre Jérôme, CEO and co-founder of SpineGuard.
The makers of PediGuard claim it is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided through audio and visual signals. The company reports that more than 25,000 procedures have been performed with PediGuard worldwise. Several studies published in peer-reviewed medical and scientific journals have demonstrated that PediGuard detects 98 percent of pedicle breaches; presents an average screw placement accuracy of 97 percent vs. 92 percent on average for navigation); provides three-fold less pedicle perforations than with free-hand technique; and a three-fold reduction in neuro-monitoring alarms. It also limits radiation exposure by 25-30 percent and decreases by 15 percent the time for pedicle screw placement, the company says.
Also in June, the company was issued a U.S. patent for the integration of its PediGuard sensor technology directly onto the tip of a pedicle screw.
In SpineGuard’s “smart screw” concept, the sensor of the PediGuard technology is embedded in the implantable pedicle screw, and the electronics are located in the screwdriver handle.
“This patented design allows for appealing benefits: surgical work flow with time savings and ultimate assurance about the correct placement of the pedicle screw,” said Stéphane Bette, chief technology officer and co-founder of SpineGuard.
“There is a well-documented safety issue associated with pedicle screw placement and a striking need for differentiation among the existing 200 or so pedicle screw systems in an ultra-competitive arena. The PediGuard screw is a potentially game-changing technology in a global annual market of one million pedicle screw-based procedures,” added Jérôme.
Pedicle screw-based stabilization has become the gold standard for treating spine instabilities and deformities. This market is growing due to the increasing number of patients requiring surgical treatment and a larger number of surgeons being trained in pedicle screw-based technologies. Technological advancements such as minimally invasive surgery, bone substitutes, dynamic stabilization and thoracic screws further reiterate the importance of pedicle screw placement, SpineGuard officials noted.
However, accuracy of pedicle screw placement remains a critical issue in spine surgery. In recently published papers studying screw placement accuracy cited by the company, the average rate of misplaced screws is approximately 20 percent, with 2-7 percent of patients presenting neurologic complications and 4-5 percent of patients having vascular complications due to misplaced screws.
Based in Paris, France, SpineGuard’s U.S. headquarters are in San Francisco, Calif.