(Dynamic Surgical Guidance) Hear what you cannot see. Challenges in pedicle screw placement. Pedicle screw misplacement

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1 Innovation in Spine Surgery Safety DSG TM Technology (Dynamic Surgical Guidance) Hear what you cannot see Accuracy of pedicle screw placement remains a critical issue in spine surgery. A number of patients emerge from surgery with misplaced screws. Now, there is an efficient solution to this problem... Challenges in pedicle screw placement What the surgeons are saying about DSG Technology... Patient safety should be a paramount concern for spine surgeons, and incorrect placement of screws is one of the main factors that can put the patient at risk for neurologic and vascular injury. Unfortunately, the intra-operative imaging that we use to help guide and confirm screw placement also carries risks related to radiation exposure, especially to the surgeon over time, and is also a known source for bacterial contamination of the field. Christopher D. Chaput, M.D. Director of the Division of Orthopedic Spine Surgery Scott & White Healthcare Central Texas I am now using a smart-guiding instrument called PediGuard. We have cut our fluoroscopy time from 5 to 8 shots to 3 or 4 and sometimes even down to 1 or 2, which is a drastic difference from where we were, say, 4 years ago when we started using PediGuard. We know that it is impossible to do surgery without fluoroscopy. But Pediguard allows us to use fluoroscopy while significantly minimizing the amount of radiation exposure we have to take. Over a career, that could be a life-saver. Larry T. Khoo, M.D. Neurosurgeon The Spine Clinic of Los Angeles; Marketing Chair Society for Minimally Invasive Spine Surgery (SMISS) Pedicle screw misplacement Pedicle screws are the most common implants used in spinal surgery. Unfortunately, unacceptably high rates of pedicle screw misplacements in the vertebraes persist, which can lead to dramatic neurologic and vascular impairment. Scientific literature reveals that about 20% of pedicle screws are misplaced 1 using conventional techniques, causing a 2% to 11% overall complication rate 2,3,4,5,6,7,8,9,10 for spinal fusion procedures. The main risk associated with placing pedicle screws is pedicle perforation, which occurs when the screw exits the vertebrae. This can result in dural tears, vascular injury, nerve injury or, rarely, spinal cord injury. (NICE ) Cost implications Based on 3 economic studies 12,13,14 conducted in the US the direct cost for a revision surgery to correct a misplaced screw ranges from $17,650 to $27,677. Those studies do not include indirect costs such as physician (office), diagnostic imaging, medication, injections, etc Dangers of radiation Often, fluoroscopy is used to check the progress of the drilling prior to inserting the pedicle screws or to check their correct placement. It is an imaging technique commonly used to obtain real-time images of the patient s anatomy and involves high levels of x-ray radiation. While a patient s exposure to X-ray is often limited to one surgery, spine surgeons who perform several surgeries a year are exposed to x-ray radiation to a greater extent. Surgeons greater reliance on fluoroscopy during procedures exposes the OR team to dangerous radiation. Radiation exposure in spine surgery is excessive, protection is underutilized, and the long-term biological effects can be deadly. Fortunately, there is a growing concern among influential spine surgeons who are calling for the reduction of radiation vulnerability in the OR. The average spine surgeon will receive the maximum allowable lifetime exposure of radiation for workers within 10 years of practice 16. Surgeons are highly exposed especially in MIS surgeries and scoliosis surgeries. Anything we can do to help us get a safer screw insertion is certainly worthwhile, given that published rates of pedicle screw misplacements can be as high as 40 percent. PediGuard will probably become a standard tool in any spine surgery requiring instrumentation. Randal Betz, M.D. Pediatric Orthopaedic Surgeon Philadelphia We surgeons are constantly faced with difficult treatment planning for complex cervical deformities. By integrating the PediGuard device into surgery, we are able to provide our patients with greater construct stability, less neurological risk, and a better overall surgical outcome. Heiko Koller, M.D. Werner Wicker Klinik Bad Wildungen Germany When not using PediGuard, we would regularly reach our facility mandated radiation level by October and not be permitted to operate for the rest of the year. With PediGuard, we have been able to keep our radiation exposure low. Mokbel Chedid,M.D. Neurosurgeon Henry Ford Hospital Detroit, Michigan

2 DSG (Dynamic Surgical Guidance) Technology What the surgeons are saying about DSG Technology... Because of the off-set axis of PediGuard Curved, it alerts me if there is a breach and where that breach is. Ciaran Bolger, M.D. Head of Department for Clinical Neuroscience, Royal College of Surgeons in Ireland, Director of Research & Development, National Neurosurgical Unit, Beaumont Hospital, Ireland, Current President of the EuroSpine Society Cannulated PediGuard gives me security during pedicle drilling while decreasing the number of X-ray shots and without using additional expensive equipment. There are no new steps to add to the procedure and the device is compatible with any pedicle screw system available on the market. For all of these reasons: security, OR team protection, universality and compatibility, the Cannulated PediGuard is a clear solution to the challenges in MIS. Charles Court, M.D. PUPH, Hôpital Bicêtre Paris, France The new miniaturized sensor of the XS Curved PediGuard allows us to access the smallest and most difficult pedicles encountered in our deformity cases. Like for the precedent design, the new curve gives us precious directional information as well as the ability to redirect. In a teaching context, it is very reassuring to receive the instant auditory feedback when the resident or any other trainee is creating the trajectory for the screw within the pedicle. Sergey Neckrysh, M.D. Chief of Spine Surgery, Assistant Professor Department of Neurosurgery, University of Illinois Chicago Maurice Bourlion, Ph.D. and Ciaran Bolger, M.D. invented the DSG Technology, which is based on the differential electrical conductivity in various tissue types. This principle is effectively utilized during insertion of screw implants in the spine via realtime feedback provided as audio and visual cues to the surgeon. The PediGuard Probes (commercialized in about 50 countries) The PediGuard Probes are the first devices that incorporate the DSG Technology. They are the world s first and only standalone, handheld instruments capable of accurately detecting changes in tissue type, alerting surgeons of potential pedicular or vertebral breaches during pedicle screw site preparation. Real-time feedback, provided via audio and visual signals, gives surgeons additional information about the trajectory during pedicle preparation. More importantly, the use of PediGuard requires no change in surgical technique. The PediGuard probes are available in a wide range of shapes and sizes for surgeon preference (more information on - PediGuard Straight - PediGuard Curved - PediGuard Cannulated Cortical bone Cancellous bone Soft tissue / blood HIGH pitch, MEDIUM pitch, HIGH cadence LOW pitch, MEDIUM cadence LOW cadence Improving Accuracy of Screw Placement for Patients The PediGuard Probes enable spine surgeons to accurately prepare the vertebra for screw insertion. Data from several clinical studies published in peer-reviewed journals show that improved screw placement accuracy can be achieved when pedicles are prepared with the PediGuard probe. On average, screws placed after drilling with the PediGuard probes have an accuracy of more than 97.5 % 17,18,19,20,21. The PediGuard probes minimize the need for x-rays and do not require additional equipment during use. Therefore, it can significantly reduce the amount of radiation exposure for the surgeon, the hospital staff and the patient. Clinical studies have documented a 25% to 30% reduction in fluoroscopy 22,23 in standard open procedures, a 73% reduction in radiation time in (MIS) 24 minimally invasive procedures, and a 15% surgical time saving 23 when the PediGuard probes were used to prepare pedicles. Moreover, the real-time feedback from these devices provides residents and fellows greater confidence in preparing pedicles and placing screws; and also allows the surgeon trainer to make any necessary adjustments to the trajectory in real-time. Since their introduction, products with the DSG Technology have helped in improving accuracy of placing pedicle screws in the spine in over 40,000 procedures globally. As a PediGuard user for over eight years, I have benefitted using this device for pedicle screw insertion. After training and a brief learning curve, you add a third sense-the auditory-as an additional help for pedicle preparation. With time, the sound frequency and tone becomes a preeminent part of your technique. For a University Hospital, PediGuard is an invaluable teaching tool: you can assist your residents and ensure safe control of their actions. André Kaelin, M.D. Clinique des Grangettes, Geneva Switzerland PediGuard probe We have decided to adopt PediGuard in order to further increase the reliability of screw placement in the vertebrae and ensure optimum patient safety, while also reducing surgical teams and patients exposure to radiation, PediGuard uses an X-ray-free, impedance-based technology allowing the anticipation of any incorrect trajectory when inserting screws into the vertebrae. This highly reduces radiation exposure while providing a safer surgical procedure and can be effectively combined with 3D navigation. Jean-Charles Le Huec, M.D CHU de Bordeaux, France

3 What the surgeons are saying about DSG Technology enabled Pedicle Screw System The smart screw technology is an opportunity to further use the Dynamic Surgical Guidance platform to improve our ability to place pedicle screws safely, especially in a MIS setting. The benefits of this technology are far-reaching. The smart screw has the potential to influence many aspects of pedicle screw placementaccuracy, decreased radiation exposure, and improved bone/screw fixation to name a few. John I. Williams, M.D. Orthopedic Surgeon, Fort Wayne, Indiana Integrating the Dynamic Surgical Guidance technology with pedicle screws will greatly optimize the workflow and accuracy, and reduce radiation exposure for surgeons in both the traditional and MIS surgical settings. Not only will the smart screw allow for active real time guidance breach-avoidance through the pedicle, but it will also provide unprecedented feedback and confidence in the ultimate fixation of the screw itself. Larry T. Khoo, M.D. Neurosurgeon The Spine Clinic of Los Angeles Society for Minimally Invasive Spine Surgery (SMISS) The PediGuard has shown its accuracy in pedicle preparation. The partnership between SpineGuard and NeuroFrance is a great development for the spine surgeon community with the integration of two technologies into one device - a new screw with an original design combined with the DSG technology. This first dynamically guided screw will be the most innovative device of the year in Spine surgery, as it will further reduce complications and associated costs. We look forward to using it. Patrick Tropiano M.D. Professor of Orthopaedic Surgery at Marseille La Timone University Hospital France DSG Technology enabled Pedicle Screw System (in development, first surgeries scheduled end of 2015) The DSG Screw System (smart screw) takes the DSG Technology one step further. It potentially eliminates the need for preparing a pedicle prior to screw insertion. This may significantly minimize the surgical procedure time, and further reduce the chance of cortical wall breaches or pedicle compromise. The DSG Screw system includes a cannulated pedicle screw, a DSG Pin with the proprietary DSG bipolar sensor embedded, and a DSG Handle assembly, which includes the electronics to read and translate the signal from the DSG sensor. Pedicle Screw DSG Pin embedding the DSG TM sensor Screws* that incorporate the DSG Technology are of a specific design that allows non-skiving cortex coasting, bone penetration without pilot hole and controlled redirection when needed as the screw is being advanced into the pedicle. K-wire less technique in MIS DSG Handle The DSG Screws are designed to enhance the ease of insertion of screws during percutaneous approaches. The DSG Screw system obviates the need for a k-wire (which is typically used in MIS / percutaneous surgical approaches to help guide instruments and implants during such procedures along a desired trajectory). This one-step insertion technique may drastically decrease the amount of radiation exposure, typically used during such procedures, not only for the patient but also for the surgeon and the OR staff. Therefore, it is anticipated that the time required for screw placement may also be reduced considerably. Cortical Bone Trajectory (CBT) technique The (CBT) technique is a new pedicle screw fixation method for lumbar spine surgery. CBT differs from traditional pedicle screw trajectory in the starting point and insertion direction. The new trajectory penetrates a region that is richer in cortical bone compared to when using the traditional trajectory and offers higher cortical bone contact. I am able to place longer screws, with higher confidence with DSG s prospective detection method and that informs me typically before, not after I have created a breach in the cortical bone, said Richard Hynes, M.D. I was able to trial the DSG screw in the lab before its release. It worked like a charm. It is an awl (removable), tap and monitored screw, all in one. No guide pin that can be advanced inadvertently is needed. I knew immediately where the trajectory of the screw was going, even without fluoroscopy. Rather than use 5 steps to put a screw into the spine, only one step was needed. I could redirect it easily if needed. I even used it to perform a new technique that I had never done before, and finished putting the screw in perfectly on two separate tries within 90 seconds from the time of the skin incision using only 3 x-rays per screw. I believe that this novel technology will be a game changer for spine surgeons. I look forward to using it clinically as soon as it gets approved. Thomas Freeman, M.D. Professor, college of medicine neurosurgery, USF Health Tampa, Florida inside DSG adds auditory cues combined with visual cues from fluoroscopy during the Cortical Bone Trajectory MIDLF approach. This results in remarkable improvement in accuracy and safety while placing the maximal length screw possible. Richard Hynes, M.D. The B.A.C.K Center Melbourne, Florida * As of July 2015, two co-development partnerships have been signed with NeuroFrance (NFI) and Zavation.

4 DSG Technology enabled Threaded Drill system (First surgery performed in September 2015) What the surgeons are saying about DSG Technology enabled Threaded Drill System The DSG Threaded Drill system includes a DSG cannulated threaded drill, a DSG Pin with the proprietary DSG bipolar sensor embedded, and a DSG Handle assembly, which includes the electronics to read and translate the signal from the sensor. DSG TM Threaded Drill As a long standing user of PediGuard probes, I find that this smart threaded drill is a useful technical improvement. It allows to prepare the entry point, redirect the trajectory when needed and remain in cancellous bone. If appropriate, we can cross the cortical wall with a very high level of precision Richard Assaker, M.D. Professor of Neurosurgery at Centre Hospitalier Universitaire de Lille, France DSG Pin embedding the DSG TM sensor The DSG Pin used in the Threaded Drill system protrudes from the tip of the DSG TM threaded drill. The DSG TM sensor, placed in front of a specifically designed awl type nose and progressive thread shape, allows for identifying tissue type and redirecting as necessary before the main threads of the threaded drill engage with bone. DSG Pin protrudes in front of the Threaded Drill DSG Handle We are performing increasingly complex procedures on our patients with superior outcomes that we could not have imagined even a decade ago. With this increase in complexity, though, there is more potential risk. As spinal surgeons, we have a responsibility to embrace any new technology that can help decrease risk to our patients. Dynamic Surgical Guidance does just that. Peter Gabos, M.D. Nemours/Alfred I. dupont Hospital for Children Wilmington The DSG Threaded Drill potentially eliminates the need for drilling the pedicle with a probe. Combining the drilling and tapping into one step may reduce the surgical procedure time, and minimize cortical wall breaches or pedicle compromise. The DSG technology will change the way spine surgery is performed. It will allow us to place spinal instrumentation faster, safer and with greater accuracy minimizing the risks to our patients. Victor Hayes, MD. Orthopedic Surgeon Fort Wayne, Indiana The inherent design of the DSG Threaded Drills makes it an optimal choice for use in MIS/percutaneous procedures. Additionally, the DSG Threaded Drills allow the surgeon to take advantage of this unique technology without having to change the implant system they are familiar with. DSG : A Game Changer With its expanded applications and inherent cost benefit to the healthcare system, devices with the DSG Technology can be expected to be standard of care in spinal stabilization in the near future. inside

5 Bibliography 1. Mason A et al. The accuracy of pedicle screw placement using intraoperative image guidance systems. J Neurosurg Spine Feb;20(2): Amato V et al. Accuracy of pedicle screw placement in the lumbosacral spine using conventional technique: computed tomography postoperative assessment in 102 consecutive patients. J Neurosurg Spine Mar;12(3): Amiot LP et al. Comparative results between conventional and computer-assisted pedicle screw installation in the thoracic, lumbar, and sacral spine. Spine 2000 Mar 1;25(5): Waschke A et al. CT-navigation versus fluoroscopy-guided placement of pedicle screws at the thoracolumbar spine: single center experience of 4,500 screws. Eur Spine J Mar;22(3): Sarlak A et al. Evaluation of thoracic pedicle screw placement in adolescent idiopathic scoliosis. Eur Spine J Dec;18(12): Epub 2009 Jun Oh HS et al. Comparison between the accuracy of percutaneous and open pedicle screw fixations in lumbosacral fusion. Spine J Dec;13(12): Koktekir E et al. Accuracy of Fluoroscopically Assisted Pedicle Screw Placement: Analysis of 1218 Screws in 198 Patients. Spine J Apr 3. [Epub ahead of print] 8. Nevzati E et al. Accuracy of Pedicle Screw Placement in the Thoracic and Lumbosacral Spine Using a Conventional Intraoperative Fluoroscopy-Guided Technique: A National Neurosurgical Education and Training Centre Analysis of 1236 Consecutive Screws. World Neurosurg Jun 17. [Epub ahead of print] 9. Kerry G et al. Intraoperative three-dimensional fluoroscopy after transpedicular positioning of Kirschner-wire versus conventional intraoperative biplanar fluoroscopic control: A retrospective study of 345 patients and 1880 pedicle screws. J Craniovert Jun Spine [serial online] Available from: asp?2014/5/3/125/ Krauss M et al. Computer-Aided Surgery Does Not Increase the Accuracy of Dorsal Pedicle Screw Placement in the Thoracic and Lumbar Spine: A Retrospective Analysis of 2,003 Pedicle Screws in a Level I Trauma Center. Global Spine J. Dec NICE: Medtech innovation briefing. The PediGuard for placing pedicle screws in spinal surgery. Published: 25 March Hodges SD et al. Analysis of CT-based navigation system for pedicle screw placement. Orthopedics Aug 1;35(8):e Watkins RG et al. Cost-effectiveness of image-guided spine surgery. Open Orthop J Aug 6;4: Sanborn MR et al. Cost-effectiveness of confirmatory techniques for the placement of lumbar pedicle screws. Neurosurg Focus Jul;33(1):E Ul Haque M et al. Radiation exposure during pedicle screw placement in adolescent idiopathic scoliosis: is fluoroscopy safe. Spine. 2006;31: Defino H et al. Does The Use Of Dynamic Surgical Guidance Assist With Accurate Pedicle Screw Placement In Patients With Osteoporosis Or Osteopenia? Bolger C et al. Electrical conductivity measurement: a new technique to detect iatrogenic initial pedicle perforation. Eur Spine J Nov;16(11): Williams J. Anticipation of vertebral pedicle breach through dynamic surgical guidance. Coluna/Columna. 2014;13(3): Syed HR et al. The Use of an Electrical Conductivity-Monitoring Device (ECMD) Shortens the Learning Curve for Accurate Placement of Pedicle Screws: A Cadaveric Study. Presented at the CNS Ovadia D et al. The Contribution of an Electronic Conductivity Device to the Safety of Pedicle Screw Insertion in Scoliosis Surgery. Spine (Phila Pa 1976) Sep 15;36(20):E1314-E 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 E1321 and J Coluna/Columna 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 Feb 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 For more information on SpineGuard and the DSG TM Technology, please visit our website at SpineGuard S.A. 10, Cours Louis Lumière Vincennes, France Phone: Fax: SpineGuard Inc Sutter Street, Suite 510 San Francisco, CA USA Phone: Fax:

(Dynamic Surgical Guidance) Hear what you cannot see. Challenges in pedicle screw placement. Pedicle screw misplacement

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