SpineGuard
 | This article contains promotional content. (December 2016) |
SpineGuard, S.A. is a French company that develops and markets probes for the enhancement of spine surgery. The probes, termed PediGuard devices, assist spine surgeons in more accurately drilling a pilot hole in preparation for pedicle screw insertion.[1]
History
[edit]Founded in 2009, SpineGuard is a spin-off of SpineVision.[2][3][4] SpineGuard founders Pierre Jerome and Stephane Bette purchased the assets of the technoion with financial assistance from institutional investors.[2][4] Along with inventors Maurice Bourlion, PhD; Ciaran Bolger, MD, Ph.D., a neurosurgeon from Dublin, Ireland; Alain Vanquaethem, a biomedical engineer; and other leading surgeons, the founders developed a technology, Dynamic Surgical Guidance (DSG), intended to make spine surgery safer.[4][5][6]
In 2013, SpineGuard went public (ALSGD).[7] It is currently traded on the AlterNext exchange in France.
The corporate headquarters of SpineGuard are in Vincennes, near Paris, France.[2] To support the DSG Technology and its adoption in the US market, SpineGuard Inc. maintains a sales and marketing office in San Francisco, California.[2] SpineGuard also has sales coverage with a network of about 45 distributors worldwide.[citation needed]
Technology
[edit]The DSG Technology is based on the differential electrical conductivity of various tissue types. It has been determined that blood, neural and vascular tissue have the most conductivity, cancellous bone has medium conductivity, and cortical bone has the least conductivity of all tissues that are encountered during a typical spinal fusion procedure. Audible and visual signals indicate tissue type based on measurements of electrical conductivity.[8]
SpineGuard products prepare the pilot hole for pedicle screw placement during spine surgery.[9] The PediGuard probes address various spine pathologies and surgical approaches.[10][11] The PediGuard probe is FDA-cleared[4][12] and CE-marked,[4] but it is not cleared for use in the cervical spine by the FDA in the US.[2]
The PediGuard probe is a stand-alone, handheld device that can detect possible vertebral cortex perforation during pedicle preparation for screw placement. The PediGuard probes can alert the surgeon prior to a breach by accurately analyzing the electrical conductivity of the surrounding tissues in real-time.[1] This, in turn, can prevent a cortical breach and also help the surgeon redirect the probe and advance down the desired path.[13] Clinical studies have shown that the PediGuard devices can reduce radiation exposure and screw placement time during the spinal procedure.[14][15][16]
References
[edit]- ^ a b Bolger C et al. Electrical conductivity measurement: a new technique to detect iatrogenic initial pedicle perforation. Eur Spine J. 2007 Nov;16(11):1919-24
- ^ a b c d e SpineGuard raises $11 million and acquires PediGuard® business unit from SpineVision. The news site of Credit Agricole Group. Crédit Agricole S.A. Web. 14. April. 2009. <http://www.credit-agricole.com/en/News/Press-releases/General-Press-Releases/SpineGuard-raises-11-million-and-acquires-PediGuard-R-business-unit-from-SpineVision2>
- ^ Matsey, Jonathan. SpineGuard launches with $11M, SpineVision Unit. Dow Jones. Dow Jones. Web. 9 April. 2009. [1]
- ^ a b c d e Kronemyer, Bob. SpineGuard SA. Start-up. Informa PLC. Web. October. 2012. http://www.mst.ru/publications/eng/spinal/PediGuard/Article_Start_up.pdf
- ^ Ciaran Bolger. Spinal News International. BIBA Medical. Web. 25. May. 2012. <http://www.spinalnewsinternational.com/sn-profiles/spinal-news---profiles/ciaran-bolger>
- ^ Biography. Maurice Bourlion Website. n.p, 2013. Web. 2015.12.15. http://maurice.bourlion.free.fr/pages/US_Biography.htm
- ^ Perriello, Brian. SpineGuard IPO drums up $11M. Mass Device. Mass Device. Web. 29 April. 2013. <http://www.massdevice.com/spineguard-ipo-drums-11m/>
- ^ Guillen P. et al. Independent assessment of a new pedicle probe and its ability to detect pedicle breach: a cadaveric study. J Neurosurg: Spine / August 29, 2014
- ^ Hofheinz, Elizabeth. SpineGuard receives CE mark for drill, announces first surgery. Orthopedics This Week. RRY Publications, 8 October. 2015. Web. 8 October. 2015.
- ^ Koller H. et al. In vitro study of accuracy of cervical pedicle screw insertion using an electronic conductivity device (ATPS part III). Eur Spine J (2009) 18:1300–1313
- ^ Ovadia D et al. The Contribution of an Electronic Conductivity Device to the Safety of Pedicle Screw Insertion in Scoliosis Surgery. Spine. 2011 Sep 15;36(20):E1314-E1321
- ^ Eisner, Walter. FDA clears SpineGuard miniature instruments. Orthopedics This Week. RRY Publications. Web. 4 September. 2013. https://ryortho.com/breaking/fda-clears-spineguard-miniature-instruments/
- ^ Williams J et al. Anticipation of vertebral pedicle breach through dynamic surgical guidance. Coluna/Columna. 2014;13(3):210-3
- ^ Bai YS, Wong HK et al. Comparison of the Pedicle Screws Placement Between Electronic Conductivity Device and Normal Pedicle Finder in Posterior Surgery of Scoliosis. J Spinal Disord Tech. 2012 Feb 6
- ^ Chaput C et al. Prospective, Randomized Trial of a New Pedicle Drilling Probe that Measures Electrical Conductivity and Reduces Radiation Exposure. Spine 2012 Oct 15; 37(21): E1314–E132 and J Coluna/Columna 2013
- ^ Lubansu A et al. Prospective Evaluation of a Free-Hand Electrical Conductivity Measuring Device to Reduce Radiation Exposure during Fluoroscopically Assisted Open or Minimally Invasive Pedicle Screw Arthrodesis. Erasmus. EurosSpine 2011