One-Tool VIPER PRIME™ Pedicle Screw System and CONCORDE® Clear MIS Discectomy Tool for MIS Spinal Fusion Surgery Launch in the United States
ORLANDO, Fla. – October 25, 2017 –DePuy Synthes* today is launching two solutions for minimally invasive spinal fusion surgery (MIS) designed to simplify the procedure, particularly as MIS gains traction and shows reduced complications compared to open surgery in treating degenerative disc disease in the back.1,2
Research shows the number of MIS fusion surgeries conducted in 2010 accounted for one-sixth of the total number of all spine surgeries in the United States and is expected to be more than half of all spine surgeries in 2020.3 As MIS becomes more common, there is a significant need to simplify these procedures, especially the complexity associated with degenerated disc removal and pedicle screw insertion.
The VIPER PRIME™ System combines multiple instruments into one pedicle screw inserter tool that reduces the number of instrument passes. The single-use CONCORDE® Clear MIS Discectomy Tool allows surgeons to complete the degenerated disc-clearing process faster on average and more efficiently compared to traditional discectomy tools while increasing the amount of disc material removed.4 These products are being showcased here at the North American Spine Society meeting.
“As a global leader in spine, we have a responsibility to continue to innovate to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine. “Both the VIPER PRIME System and the CONCORDE Clear MIS Discectomy Tool are examples of how we are providing differentiated technologies that simplify spine surgery and make it more reproducible for every surgeon while reducing the impact on patients.”
VIPER PRIME System Inserts Pedicle Screws with Single Instrument Pass
Currently, the MIS screw insertion technique may consist of numerous instruments, involves the use of tools like Jamshidi needles and guidewires, and requires multiple instrument passes in and out a patient’s body, all of which contribute to procedural complexity. The VIPER PRIME System combines many of these instruments into one single tool and reduces the number of instrument trays to two**. A new screw tip design and stylet that is fully controlled by the screwdriver allows surgeons to target pedicles and insert the screw in one single instrument pass. In one bench study, the VIPER PRIME System demonstrated a 33 percent reduction in the time required to insert a pedicle screw through an MIS technique compared to traditional techniques.5 Additionally, the system’s streamlined instrument set means a smaller procedural footprint that also helps reduce waste, processing costs and environmental impact.6
CONCORDE Clear Discectomy Tool Removes Degenerated Disc in Under Four Minutes4
Disc removal in spinal fusion surgery requires the surgeon to work through a small surgical field with limited visualization. It also typically requires multiple instruments and instrument passes to make sure the disc is cleared and the end plates of the vertebrae are prepped for implants, which increases the risk of nerve root injury. The CONCORDE Clear Device is a single-use instrument that uses standard operating room suction to remove the degenerated disc and prepare the endplates, a simplified approach that is faster on average and results in a reduction in tool passes and instrument exchanges compared to traditional techniques.4*** A clear handle enables surgeons to visualize collection of disc material.
About DePuy Synthes Companies
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies****, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries. MEDOS INTERNATIONAL, SARL is the legal manufacturer of the VIPER PRIME System and the CONCORDE Clear MIS Discectomy Tool.
**Compared to the VIPER® 2 MIS System
***Comparing CONCORDE Clear MIS Discectomy Tool vs. traditional discectomy tools
****The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.
©DePuy Synthes 2017. All rights reserved.
- Jhala, Amit, et al. Minimally invasive transforaminal lumbar interbody fusion. Indian Journal of Orthopaedics 48(6) (2014 Nov-Dec); 562-567.
- Peng, Chan Weam Benedict, et al. Clinical and Radiological Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion. SPINE Vol. 34, Number 13 (2009); 1385-1389.
- Phillips F. M., Cheng I., Rampersaud Y. R., et al. Breaking through the 'glass ceiling' of minimally invasive spine surgery. Spine. 2016;41, S8:S39–S43.
- Araghi, A. Novel Technologies for MIS Fusion Discectomy and Expandable Interbody. ISASS Boston September 18-20 2015.
- Adaptiv #103327910 (Analysis 1): Percent Reduction in Time for the Viper Prime Technique Compared to the Traditional Jamshidi/Guidewire Technique. Bench test results may not be indicative of clinical performance.
- Earthwards Scorecard Results: VIPER PRIME System.