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TRIGEN SURESHOT

Distal Targeting System

Product Information


The revolutionary TRIGEN SURESHOT system is a safe, convenient, and cost effective technology for fracture repair in the OR.

 

Problem: Current Methods of Distal Locking
Current Solution: Perfect Circles

• Surgeon reliant on staff expertise
• Fluoroscopy - Radiation exposure
• Technique dependent - Learning curve
• Position dependent - Potential for fracture misalignment

What is it?

• Electromagnetic field tracking technology
• Sensor on probe inserted into the nail
• Projects virtual image of distal end of nail on screen
• Provides real time feedback without fluoroscopy
• Green and red concentric circles = perfect circles

Revolutionary technology that puts you in full command of distal locking

• The first and only virtual real-time imaging system for distal locking
• For years, distal locking with the free-hand fluoroscopic method has been the standard of care—now there's a new standard
• Not a new technique, but a brilliant new technology that offers full surgeon control, a reduction in radiation exposure, and shorter procedures
• Works seamlessly with the proven TRIGEN Nail family: META-NAIL*, TAN*, FAN*, Humeral, Pediatric and Adolescent nails


TRIGEN SURESHOT system: At your command


1. Computer-based calibrated software provides perfect circle targeting
2. Continuous visual real-time feedback of drill position ensures correct direction and angle
3. All under your direct control; requires no fluoroscopy during distal locking

Benefits
• Safety
• Cost
• Control

Download the TRIGEN SURESHOT Product Brochure

Safety, Cost, and Control


Safety, Cost, and Control

 

Safety

“Any radiation dose carries with it an associated risk of cancer induction, and the risk increases linearly with increasing dose." 5
--- Klein et al, 2009

Radiation is a well-established risk factor for cancer 1
• The relationship between exposure to ionizing radiation and cell damage, which may result in cancer, is well documented in the literature1-3

Radiation can also cause other problems
• Circulatory disease 6
• Cataract formation 5
• Genetic mutation potentially causing hereditary effects 4
• By causing mutations in germ cells, radiation may have an effect on offspring


A significant dose response causes increased risks For each rad of radiation exposure a surgeon receives in a lifetime, risks increase.



The National Council on Radiation Protection & Measurements (NCRP) recommends using as low as reasonably achievable (ALARA) levels of radiation8

 

Cost

The TRIGEN SURESHOT system helps increase efficiency and reduce variability with shorter procedures 1
• The variability in procedure time for distal locking is due to the number of fluoroscopic images and the time it takes to precisely target and align the distal locking holes
• The TRIGEN SURESHOT reduces variability in both alignment and procedure time, allowing surgeons, staff, and the OR to be deployed to other revenue-producing activities

 

Click Here to learn how TRIGEN SURESHOT can reduce costs

 

Control

Get your Radiation Exposure Under Control
• Enhance safety of staff and patients by using as low as reasonably achievable (ALARA) levels of radiation during distal locking

• Eliminate fluoroscopy radiation time associated with distal locking 4

• Eliminate fluoroscopy radiation exposure associated with distal locking 4



Safety References

1. Cardis E, Vrijheid M, Blettner M, et al. The 15-country collaborative study of cancer risk among radiation workers in the nuclear industry: estimates of radiation related cancer risks. Radiat Res. 2007;167(4):396-416.

2. Muirhead CR, O'Hagan JA, Haylock RG, et al. Mortality and cancer incidence following occupational radiation exposure: third analysis of the National Registry for Radiation Workers. Br J Cancer. 2009;100(1):206-212.

3. Sont WN, Zielinski JM, Ashmore JP, et al. First analysis of cancer incidence and occupational radiation exposure based on the National Dose Registry of Canada. Am J Epidemiol. 2001;15 (4):309-318.

4. Report of the United Nations Scientific Committee on the Effects of Atomic Radiation to the General Assembly. 2000. http://www.unscear.org/docs/reports/gareport.pdf . Accessed February 17, 2010.

5. Klein LW, Miller DL, Balter S, et al. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009;73(3):432-438.

6. Center for Devices and Radiological Health, US Food and Drug Administration. Initiative to reduce unnecessary radiation exposure from medical imaging. http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm . Updated February 16, 2010. Accessed February 22, 2010.

7. Ashmore JP, Krewski D, Zielinski JM, Jiang H, Semenciw R, Band PR. First analysis of mortality and occupational radiation exposure based on the National Dose Registry of Canada. Am J Epidemiol. 1998;148(6):564-574.
8. National Council on Radiation Protection & Measurements. The application of ALARA for occupational exposures. NCRP Statement No. Issued June 8, 1999.
http://www.ncrponline.org/Publications/Statement_8.pdf . Accessed February 22, 2010.

 

Cost References

1. Tornetta P, Patel P, Tseng S, Whitten A, Ricci W. Distal locking using an electromagnetic field guided computer based real time system. Poster presented at: Annual Meeting of the Orthopaedic Trauma Association; October 8-10, 2009; San Diego, CA.

2. Peersman G, Laskin R, Davis J, Peterson MG, Richart T. Prolonged operative time correlates with increased infection rate after total knee arthroplasty. HSS J. 2006;2(1):70-72.

3. Data on file. Smith & Nephew.
Control References
1. Center for Devices and Radiological Health, US Food and Drug Administration. Initiative to reduce unnecessary radiation exposure from medical imaging.
http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm . Published February 2010. Accessed February 11, 2010.

2. Whatling GM, Nokes LD. Literature review of current techniques for the insertion of distal screws into intramedullary locking nails. Injury. 2006;3 (2):109-119.

3. Data on file. Smith & Nephew.

4. Tornetta P, Patel P, Tseng S, Whitten A, Ricci W. Distal locking using an electromagnetic field guided computer based real time system. Poster presented at: Annual Meeting of the Orthopaedic Trauma Association; October 8-10, 2009; San Diego, CA.

Control References

1. Center for Devices and Radiological Health, US Food and Drug Administration. Initiative to reduce unnecessary radiation exposure from medical imaging. http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm . Published February 2010. Accessed February 11, 2010.

2. Whatling GM, Nokes LD. Literature review of current techniques for the insertion of distal screws into intramedullary locking nails. Injury. 2006;3 (2):109-119.

3. Data on file. Smith & Nephew.

4. Tornetta P, Patel P, Tseng S, Whitten A, Ricci W. Distal locking using an electromagnetic field guided computer based real time system. Poster presented at: Annual Meeting of the Orthopaedic Trauma Association; October 8-10, 2009; San Diego, CA.


Clinical Evidence


TRIGEN SURESHOT Clinical Evidence

TRIGEN SURESHOT Reducing Radiation Risk


Moore, Chris, MS; Heeckt, Peter, MD. Reducing Radiation Risk in Orthopaedic Trauma Surgery, Bone&Joint Science. Vol 02, No 07 - July 2011

Radiation risk to the orthopaedic trauma surgeon and OR staff originates from two sources. There are four primary protective measures which can limit primary and scatter radiation exposure.

Download Reducing Radiation Risk in Orthopaedic Trauma Surgery Research Paper

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

White Paper prepared by the FDA and Center for Devices and Radiological Health

Through the initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, FDA and our partners will work to measurably reduce unnecessary exposure to patients to radiation in CT, fluoroscopy, and nuclear medicine imaging exams.

Download FDA White Paper

The Magic Wand For Distal Targeting

Tornetta III, Paul; Whitten, Andy; Patel, Priyesh; Tseng, Susan; Ricci, William


A new technology, using an electromagnetic field generator, a wand that goes down the nail, and computer based calibrated software has been created to allow distant locking without fluoroscopy.

Download The Magic Wand For Distal Targeting White Paper



Design and Technology


TRIGEN SURESHOT Design Rationale

Screw targeting during intramedullary nailing of long bone fractures can be a laborious process and is highly dependent upon flouro technicians, often becoming the most frustrating and time-consuming step of the procedure. The vast majority of surgeons use a fluoroscopic method reliant upon obtaining ‘perfect circles'. This technique requires assistance to hold the extremity in a specific position and expertise from the radiology technician. Additionally, this technique is characterized by a moderate learning curve with variable accuracy, the potential for screw malalignment and exposes the patient and surgical staff to radiation.

The TRIGEN SURESHOT Distal Targeting System utilises an electromagnetic field generator, a probe inserted into the nail, and virtual imaging to facilitate distal locking without fluoroscopy. This revolutionary system is radiation free, position independent, and provides 3D real time feedback of location and orientation of the drill relative to the nail interlocking hole to provide unsurpassed accuracy. The TRIGEN SURESHOT Distal Targeting System was designed to mimic the ‘perfect circle' technique and has virtually no learning curve.

In combination with the superior TRIGEN IM Nail System, the TRIGEN SURESHOT Distal Targeting System allows surgeons to exercise maximum operating room control, benefitting everyone including the patient and OR staff. TRIGEN SURESHOT delivers optimal outcomes by providing the surgeon maximum command during intramedullary nailing and by reducing radiation exposure, anesthesia time and time in the OR, all while increasing accuracy.

The TRIGEN SURESHOT Distal Targeting System is the revolutionary approach to distal locking and further establishes the TRIGEN IM Nail System as the driving force in advancing and improving the efficacy of intramedullary nailing.

Indications


TRIGEN SURESHOT Indications

The Smith & Nephew TRIGEN SURESHOT Distal Targeting System is intended to be an intraoperative image-guided localisation system. It is a computer-assisted orthopaedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew TRIGEN SURESHOT Targeting System V2.1 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate. An example of a surgical procedure includes but is not limited to locating and drilling the distal holes in an intramedullary nail.

Contraindications
The screw targeting software application for this system is contraindicated for all IM nails other than Smith & Nephew TRIGEN META-NAIL, TAN, FAN, Humeral, Pediatric and Adolescent nails. Do not operate the TRIGEN SURESHOT Targeter within 200mm of an installed pacemaker. The magnetic field produced by the Targeter may interfere with the operation of the pacemaker.

Intended use
The TRIGEN SURESHOT Distal Targeting System is only designed for use with the indicated implants and instruments. Implants and instruments must be used in accordance with the instructions, as described in this manual and/or in the non-navigated surgical procedure.

Training
Only trained operators are allowed to use the TRIGEN SURESHOT Distal Targeting System. The various operating instructions must be fully read and understood as part of the training. If any part of the instructions is not clear, please contact your local representative.

Download the TRIGEN SURESHOT User Manual