Medtronic Announces Launch of the POWEREASE(TM) System

MEMPHIS, Tenn., Apr 16, 2012 (BUSINESS WIRE) — Medtronic, Inc. today announced the initiation of its launch of the POWEREASE(TM) System, an innovative system of electronic instruments designed specifically for use in instrumented, or reconstructive, spine surgery. This system brings new capability to the operating room through compatibility with two of the leading pedicle screw platforms on the market, the CD HORIZON(R) SOLERA(TM) Spinal System and the TSRH(R) 3Dx(TM) Spinal System, and is integrated with other advanced surgical technologies, specifically Medtronic’s NIM-ECLIPSE(R) neuromonitoring, O-ARM(R) imaging, and STEALTHSTATION(R) navigation systems.
“Biomechanical testing demonstrated that when compared with traditional instruments used for delivering spinal therapy, the POWEREASE(TM) System reduces surgeon’s fatigue associated with repetitive hand motion and enhances surgeon control, including in complex reconstructions of the spine,” said Doug King, Senior Vice President and President of Medtronic Spinal. “We’re pleased to couple advanced power technology with our proprietary neuromonitoring and surgical navigation systems, which enable a more informed procedure.”
The POWEREASE(TM) System is used for drilling, tapping and driving specialized implants during spinal surgery, including open and minimally invasive procedures. The system is also used in final construct assembly. Risks for the system include, breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may cause injury to the patient or operative personnel.
Through biomechanical testing versus manual instruments, the POWEREASE(TM) System demonstrated 51% less time required for tapping the pedicle and 55% less time required for placing pedicle screws. This testing also showed greater control with 38% less wobble, defined as maximum radial movement of the instrument from the center axis of the instrument or screw when placing pedicle screws, compared to manual instruments. Biomechanical testing is not necessarily indicative of human clinical outcome.
The POWEREASE(TM) System was developed jointly by Medtronic’s Spinal and Surgical Technologies business units. The system utilizes Surgical Technologies’ IPC(R) (Integrated Power Console).
About the CD HORIZON(R) SOLERA(TM) Spinal System Medtronic’s CD HORIZON(R) SOLERA(TM) Spinal System is the fifth generation of this spinal fusion system and is cleared to treat patients with degenerative disc disease, spinal stenosis, fracture, dislocation, failed previous fusions, tumors and adolescent idiopathic scoliosis (AIS). With more than twenty-five years of clinical experience and 500,000 patients treated with the CD HORIZON(R) product line, the CD HORIZON(R) SOLERA(TM) Spinal System offers the combination of lower profile pedicle screw implants and performance. Notably, the system accommodates multiple rod material options and gives surgeons and hospitals an array of choices to treat a diverse set of spinal conditions.
About TSRH(R) Spinal System In 1987, Texas Scottish Rite Hospital (TSRH) collaborated with Medtronic- with hopes of developing a system to treat scoliosis- which led to the development of the TSRH(R) Spinal System. After more than 20 years of clinical use and the 2009 launch of TSRH(R) 3Dx(TM) Spinal System, the TSRH(R) Spinal System continues to drive innovation in spinal treatment. The system offers several types of pedicle screws, implants and other instruments to correct and stabilize the spine when treating degenerative disc disease, degenerative spondylolisthesis in skeletally mature patients, and AIS.
Risks associated with the CD HORIZON(R) and TSRH(R) Spinal Systems include loosening, disassembly, bending, and/or breakage of components, fracture, microfracture, resorption, damage, or penetration of any spinal bone. Selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure. A successful result is not always achieved in every surgical case. The safety and effectiveness of this device has not been established for use as part of a growing rod construct, and is only intended to be used when definitive fusion is being performed at all instrumented levels.