Innovation in Spine Surgery Safety

DSGTM 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...

Pedicle screw misplacementPedicle 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 misplaced1 using conventional techniques, causing a 2% to 11% overall complication rate2,3,4,5,6,7,8,9,10 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.” (NICE11 2015)

Cost implicationsBased on 3 economic studies12,13,14 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 radiationOften, 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 practice16.

• Surgeons are highly exposed especially in MIS surgeries and scoliosis surgeries.

What the surgeons are saying about

DSG™ Technology...

Challenges in pedicle screw placement

“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 WildungenGermany

“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 SurgeryScott & 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)

“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

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 real-time feedback provided as audio and visual cues to the surgeon.

Improving Accuracy of Screw Placement for PatientsThe 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 fluoroscopy22,23 in standard open procedures, a 73% reduction in radiation time in (MIS)24 minimally invasive procedures, and a 15% surgical time saving23 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 close to 40,000 procedures globally.

What the surgeons are saying aboutDSG™ 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

“I’ve learned that we must not take pedicle screw placement for granted. There’s a

very narrow margin for error. Misplaced pedicle screws can result in catastrophic complications. Also, multiple attempts at screw placement can result in less-than-optimal fixation. You only have one shot to get the best possible screw placement for any given level. I can see why PediGuard is becoming a standard tool in any spine surgery to assist us in getting a safer pedicle screw insertion.”

Ali Maziad, M.DSpine Surgery Fellow

Oakland UniversityWilliam Beaumont Health System

Rochester, Minnesota

PediGuard® probe

LOW pitch, LOW cadence

MEDIUM pitch, MEDIUM cadence

HIGHpitch, HIGH cadence

Cortical bone

Cancellous bone

Soft tissue / blood

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 stand-alone, 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.

DSG™ (Dynamic Surgical Guidance) Technology

The PediGuard® technology is available in a wide range of shapes and sizes for surgeon preference (more information on www.spineguard.com):

- PediGuard® Straight- PediGuard® Curved- PediGuard® Cannulated

“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

“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

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.

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 MISThe 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.

What the surgeons are saying about DSG™ Technology enabled Pedicle Screw System

“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)

inside

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.

DSG™ Handle

DSG™ Pin embedding the

DSGTM sensorPedicle Screw

“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 CenterMelbourne, Florida

“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 placement-accuracy, decreased radiation exposure, and improved bone/screw fixation to name a few.”

John I. Williams, M.D.Orthopedic Surgeon, Fort

Wayne, Indiana

“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

* As of July 2015, two co-development partnerships have been signed with NeuroFrance (NFI) and Zavation.

Cortical Bone Trajectory (CBT) techniqueThe (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.

“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

What the surgeons are saying about DSG™ Technology enabled Tap System

“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 ChildrenWilmington

DSG™ Technology enabled Tap system (in development, first surgeries scheduled end of 2015)

The DSG™ Tap system includes a DSG™ cannulated tap, 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.

“This is another demonstration of SpineGuard’s continued development and execution of

instruments to make spine surgery safer for patients and provide confidence to the surgical team. The pedicle screw with Dynamic Surgical Guidance will truly change the way we think about spine and orthopaedic surgery.”

Randal Betz, M.D. Pediatric Orthopaedic Surgeon

Philadelphia

“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 DSG™ Tap 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.

DSG™ Handle

DSG™ Pin embedding the DSGTM sensor

DSGTM Tap

The DSG™ Pin used in the Tap system protrudes from the tip of the DSGTM tap. The DSGTM 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 tap engage with bone.

The inherent design of the DSG™ Taps makes it an optimal choice for use in MIS/percutaneous procedures. Additionally, the DSG™ Taps allow the surgeon to take advantage of this unique technology without having to change the implant system they are familiar with.

DSG Pin protrudes in front of the Tap

DSG™: A Game ChangerWith 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

www.spineguard.com

SpineGuard® S.A.10, Cours Louis Lumière

94300 Vincennes, FrancePhone: +33 1 45 18 45 19

Fax: +33 1 45 18 45 20

SpineGuard® Inc.1388 Sutter Street, Suite 510San Francisco, CA 94109 – USAPhone: +1 415 512 2500Fax: +1 415 512 8004

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2. Amato V et al. Accuracy of pedicle screw placement in the lumbosacral spine using conventional technique: computed tomography postoperative assessment in 102 conse-cutive patients. J Neurosurg Spine. 2010 Mar;12(3):306-13.

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):606-14.

4. 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. 2013 Mar;22(3):654-60.

5. Sarlak A et al. Evaluation of thoracic pedicle screw placement in adolescent idiopathic scoliosis. Eur Spine J. 2009 Dec;18(12):1892-7. Epub 2009 Jun 14.

6. Oh HS et al. Comparison between the accuracy of percutaneous and open pedicle screw fixations in lumbosacral fusion. Spine J. 2013 Dec;13(12):1751-7.

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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. 2014 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 fluorosco-pic control: A retrospective study of 345 patients and 1880 pedicle screws. J Craniovert Jun Spine [serial online] 2014. Available from: http://www.jcvjs.com/text.asp?2014/5/3/125/142307

10. 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 2014

11. NICE: Medtech innovation briefing. The PediGuard for placing pedicle screws in spinal surgery. Published: 25 March 2015

13. Hodges SD et al. Analysis of CT-based navigation system for pedicle screw placement. Orthopedics. 2012 Aug 1;35(8):e1221-4.

14. Watkins RG et al. Cost-effectiveness of image-guided spine surgery. Open Orthop J. 2010 Aug 6;4:228-33.

15. Sanborn MR et al. Cost-effectiveness of confirmatory techniques for the placement of lumbar pedicle screws. Neurosurg Focus. 2012 Jul;33(1):E12

16. Ul Haque M et al. Radiation exposure during pedicle screw placement in adolescent idiopathic scoliosis: is fluoroscopy safe. Spine. 2006;31:2516–2520.

17. Defino H et al. Does The Use Of Dynamic Surgical Guidance Assist With Accurate Pedicle Screw Placement In Patients With Osteoporosis Or Osteopenia? 2015.

18. 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

19. Williams J. Anticipation of vertebral pedicle breach through dynamic surgical guidance. Coluna/Columna. 2014;13(3):210-3

20. 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 2014

21. 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). 2011 Sep 15;36(20):E1314-E1321

22. 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 2013.

23. 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

24. 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 DSGTM Technology, please visit our website at www.spineguard.com.