Depuy synthes spine has a long tradition of collaborating with experienced. At initial insertion, the stylet should extend past the tip of the screw to dock onto the pedicle. The viper 2 system is a single platform solution with a range of instrumentation and implant options. It allows treatment of degenerative and complex mis cases with a single versatile system. Depuy synthes spine has a new allinone pedicle screw system called the expedium verse spinal system. Cobalt chrome cocrmo connecting rods are not intended to connect to the. Food and drug administration fda for use of its expedium, viper, and viper2 spine systems on. Depuy synthes wins fda nod for viper, expedium pedicle screw. Depuy synthes launches concorde clear mis discectomy device. Fda clears depuy synthes spines expedium and viper systems.
The viper prime system eliminates the need for guidewires. Attach a depuy synthes spine expedium or viper system handle. Dec 07, 2018 this feature is not available right now. The viper prime system is also designed to improve efficiency in spinal surgery. Depuy synthes announces acquisition of sentio, llc to enable. By delivering a comprehensive range of instrumentation and implant options, the viper 2 system provides. This site is published by depuy synthes, a division of depuy orthopaedics, inc. Depuy synthes launches concorde clear mis discectomy. Please direct all other requests to one of the other depuy synthes companies or career inquiries email addresses located on this page. Depuy synthes joint reconstruction units affected depuy france sas is issuing a field safety notice for product code. Expedium viper 2 advanced rod holder video youtube. By potentially reducing the number of screws needed in a procedure, the company claims the expedium system allows surgeons to perform multiple maneuvers during fusion surgery with a single implant type and fewer instruments. Dec 12, 2017 the launch of the concorde clear device follows depuy synthes october release of the viper prime system.
According to depuy synthes, the device is singleuse, and data presented in 2015 show that it allows surgeons to remove more of the disc material. Depuy synthes 325 paramount drive raynham, massachusetts 02767 re. The launch of the concorde clear device follows depuy synthes october release of the viper prime system. The company said the systems are designed to be used with its. Oct 12, 2017 in one bench study, the viper prime system demonstrated a 33 percent reduction in the time required to insert a pedicle screw compared to traditional mis techniques. Viper tprime m system surgical technique depuy synthes step 3 pedicle targeting insert the viper prime inserter assembly through the incision and dock the stylet tip on the bony anatomy of the desired level. May 20, 2014 apss workshop video 1 lumbar pedicle screw and s1 screw duration.
This recall notice provides instructions for notifying medical professionals who may have purchased, received. Depuy expedium and viper pedicle screws for scoliosis now. The viper 2 system is designed to address a range of spinal pathologies, while maintaining a less invasive approach. Jnj business depuy synthes said today it won fda 510k clearance for its viper and expedium fenestrated screw systems intended to. Jnj business depuy synthes said today it won fda 510k clearance for its viper and expedium fenestrated screw systems intended to restore spinal column integrity in. Electric pen drive instructions for use depuy synthes 1 introduction general information 3 explanation of symbols 5 consoles standard consoles 6 basic console 7 setup of consoles 8 speed regulation 10 irrigation 11 electric pen drive system system electric pen drive 60,000 rpm 05.
This site is intended for visitors from the africa, asia, europe, latin america and pacific. It allows treatment of degenerative and complex mis cases with a. The reduction screw is designed with removable tabs that allow the surgeon. Laura bleyendaal regulatory affairs associate depuy synthes 325 paramount drive raynham, massachusetts 02767 re. Mis spine system adaptable mis solutions for an evolving. This site is published by the depuy synthes companies, which are solely responsible for its content. This site is for visitors from europe, middle east and africa. Download pdf emea viper prime navigation surgical technique guide. Compact drive with specific attachments for a wide. Jul 27, 2018 please use one of the following formats to cite this article in your essay, paper or report. Viper 2 system guide depuy synthes 3 system overview the viper 2 system is the evolution of minimally invasive spine surgery. This allows surgeons to complete the surgery more efficiently, which could lead to improved patient outcomes, a press release reads. Synthes posterior spinal stabilization systems b 3. Instructions for use connecting rods depuy synthes companies.
In one bench study, the viper prime system demonstrated a 33 percent reduction in the time required to insert a pedicle screw compared to traditional mis techniques. Depuy synthes introduces new concorde lift implant to treat. Thoracolumbosacral pedicle screw system regulatory class. Depuy synthes wins fda nod for viper, expedium pedicle.
Jnj subsidiary depuy synthes said today it it launched its viper and expedium fenestrated screw systems. This is the viper prime system, a novel technique for percutaneous pedicle screw placement that eliminates the need for guidewires, jamshidi needles and. Raynham, ma depuy synthes spine announced it has received 510k clearance from the u. All content is posted anonymously by employees working at depuy synthes. Building upon the intuitive design and techniques established by the original viper system. These screws help to address, correct and also stabilize difficult anatomic variations. Depuy synthes unveils viper prime mis pedicle screw.
Moreover, the open platform principle of brainlab spine navigation enables any instrument to be manually calibrated for navigation by attaching adapter clamps. Depuy synthes spine tells us it has received fda 510k clearance for use of its expediumpictured, viper, and viper2 spine systems on patients with adolescent idiopathic scoliosis ais, an abnormal curvature of the spine that typically affects children between the ages of 10 and 18. Aetna considers any of the following injections or procedures medically necessary for the treatment of back pain. Depuy synthes announces acquisition of sentio, llc to. Depuy synthes spine receives 510k clearance for use. Please use one of the following formats to cite this article in your essay, paper or report. Depuy synthes spine is proud to introduce a novel technique for percutaneous pedicle. The viper prime system is a technique for percutaneous pedicle screw placement that eliminates the need for guidewires, jamshidi needles and pedicle preparation instruments. Electronic instructions for use depuy synthes companies.
Apply to medical director, project lead, medical writing manager and more. Introduction 11 section 1 introduction background arthroscopy relates to the use of an arthroscope to visualize the joint space, most commonly of the knee, shoulder, ankle, elbow and wrist. Depuy synthes companies announces fiveyear cooperation. Depuy synthes unveils viper prime mis pedicle screw system. Depuy synthes concorde clear minimally invasive discectomy. The expedium spine system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. A presentation delivered by andreas korge germany and pujan kavakebi austria in 2017, describing minimally invasive surgery for pedicle. Depuy synthes spine depuy synthes spine is the second largest spine company in the world with one of the most comprehensive portfolios of spinal care solutions that address key areas including thoracolumbar, cervical, aging spine, interbody fusion, arthroplasty and minimally invasive surgery.
Arthroplasty, 1998 the corail stem receives the level 10a highest evidence rating from odep. Viper prime screws with fenestrations regulation number. Depuy synthes how the viper prime system changed my practice. Policy please see amendment for pennsylvania medicaid at the end of this cpb. This publication is not intended for distribution in the. Depuy synthes tells us viper prime is being introduced to health care professionals in the europe, middle east and africa emea region during educational and industry events. Depuy synthes spine receives 510k clearance for use of. The expedium and viperviper 2 spine systems are intended to provide. 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. Apss workshop video 1 lumbar pedicle screw and s1 screw duration. Depuy synthes introduces new concorde lift implant to. In addition to a range of brainlab instruments, cooperations with depuy synthes and other selected 3rd party manufacturers also provide navigationready integrated instruments. This website is intended for healthcare professionals only. The clear handle is designed to allow surgeons a better view of collected disc material, the company says.
Featuring a screw tip design and a stylet that is fully controlled by the screwdriver, the viper prime system enables surgeons to target pedicles and insert screws in. Glassdoor has salaries, wages, tips, bonuses, and hourly pay based upon employee reports and estimates. Mis spine system adaptable mis solutions for an evolving practice. Overview of mis pedicle screw insertion and viper prime technique. Surgical technique guide reduction the expedium polyaxial reduction screw is designed to further complement the innovative design of the existing expedium polyaxial screw range.
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