SpineGuard’s mission is to MAKE SPINE SURGERY SAFER.
SpineGuard’s primary objective is to establish PediGuard® as the STANDARD OF CARE FOR SAFER PEDICLE SCREW PLACEMENT benefitting patients, surgeons, operating room staff and health care providers.
SpineGuard is also exploring other applications for the PediGuard technology platform.
SpineGuard is a public company listed on the NYSE Alternext (ticker: ALSGD) in Paris since April 29, 2013. Pierre Jérôme and Stéphane Bette founded the company in January 2009 with the aim to fully exploit the great clinical and market potential of PediGuard, the first and only handheld device capable of alerting surgeons in real time to potential pedicular or vertebral breaches.
The original inventors of the technology, Ciaran Bolger, MD PhD and Maurice Bourlion, PhD are also part of the endeavor, as well as Randal R. Betz, MD, leader of SpineGuard’s international clinical study group. Alan Olsen, the founder of Danek Medical Inc., now Medtronic Spine, was elected as SpineGuard’s Chairman in May 2010.
The Clinical Need
Pedicle screw-based stabilization has become the gold standard for treating spine instabilities and deformities. Nearly one million spine procedures using pedicle screws are performed annually worldwide (I-Data research). Technological advancements such as minimally invasive surgery, bone substitutes, dynamic stabilization and thoracic screws further reiterate the importance of pedicle screw placement in spine surgery.
However, accuracy of pedicle screw placement remains a critical issue:
- Around 20% of pedicle screws using conventional techniques have been reported as misplaced (Tian 2011, Gelalis 2011, Verma 2010)
- 2-7% of patients have complications related to misplaced screws (Amato 2010, Amiot 2000, Waschke 2012, Verma 2012, Gelalis 2011, Mac-Thiong 2012, Konati 2007, Sarlak 2009, Samdani 2009, Belmont 2002)
With growing clinical evidence confirming its efficacy, PediGuard is emerging as the most compelling answer to the clinical needs associated with pedicle screw placement. Over 25,000 procedures have been performed with PediGuard on all continents!
The summary of SpineGuard’s comprehensive compliance program is available upon request. Please e-mail email@example.com for more information.