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From NASS: Medtronic Launches Two New Products

Novel products expand firm's spinal fusion and stabilization offerings.

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By: Michael Barbella

Managing Editor

The spine division of Medtronic Inc. unveiled new technology at this week’s 26th annual meeting of the North American Spine Society meeting in Chicago, Ill.

Included in the new offering was the firm’s new MAST MIDLF procedure, which uses a proprietary retractor and cortical bone screw fixation in conjunction with the company’s interbody, navigation, neuromonitoring and biologic technology options. Referred to clinically as a midline laminectomy approach, Medtronic officials say it is unique because enables a minimally invasive spinal fusion surgery, accessing the spine in the middle lower back, and eliminates the need for surgeons to work through a tubular retractor.

“This surgical strategy enables a highly efficient, minimally invasive lumbar fusion, while allowing visualization of familiar posterior landmarks,” according to Richard Hynes, M.D., spine surgeon at The B.A.C.K. Center in Melbourne, Fla. “A midline approach offers surgeons a number of benefits in addressing the challenges associated with decompression as well as sacral fixation in the lumbar or lower spine.”

The MAST MIDLF procedure also can be used with Medtronic’s surgical navigation and imaging systems. This allows for decreased exposure to radiation for hospital staff and physicians, with improved accuracy of device placement to avoid injury to nerves.

In the United States, more than 250,000 patients undergo spinal fusions annually to treat degenerative changes in the lumbar spine.

Minimally invasive surgery requires a smaller incision than traditional open-back surgery and reduces injury to muscles, tendons, and other normal tissues that aren’t directly involved with the back disorders. In addition, MIS surgery often leads to shorter hospital stays than traditional open spine surgeries.

Medtronic also launched the T2 Altitude Expandable Corpectomy device in the United States and Europe. The product, a self-locking expandable vertebral body replacement cage intended for use in the thoracolumbar spine (T1-L5). It is designed to provide spinal stabilization and correction in patients suffering from a traumat or cancerous tumors.

According to the company, the device features an innovative self-locking mechanism that eliminates the need for placing a set screw during surgery. This device can be filled with bone graft after insertion and also after expansion, creating bone contact with the end plate and the opportunity for fusion to occur inside the device. Possible risks include, early or late loosening of the components and implant migration and the disassembly, bending, and/or breakage of any or all of the components.

T2 Altitude comes in multiple sizes, allowing a surgeon to fit the various needs of a trauma or tumor patient. Additionally, giving surgeons options to insert the cage from a posterior, anterior or lateral approach and is compatible with Medtronic’s proprietary minimally invasive MAST technologies.

This system also is compatible with Medtronic’s neuromonitoring system, the NIM-Eclipse System. The device also is to be used with supplemental fixation such as Medtronic’s Vantage Anterior Fixation System, TSRH Spinal System, or the CD Horizon Spinal System.

Each year, there are more than 150,000 spinal fractures in North America. There is an estimated 10,000 to 12,000 spinal cord injuries every year and approximately 39 percent of these injuries are cause by motor vehicle accidents. Non-elective or trauma surgeries sometimes require additional spinal structural support, which is when the T2 Altitude is used.

Another indication or use is in the treatment of cancer patients. If the cancer metastasizes or spreads in the spine, the surgeon may opt to remove the affected vertebral bodies and replace them with the T2 Altitude.

The system also is equipped with an implant tracking system to enhance hospital efficiencies, support hospital-specific quality management and provide device utilization-related data to meet anticipated U.S. Food and Drug Administration regulations establishing a unique device identification system.

“We continue to deliver on our long-term commitment to therapies for complex spine disorders for spinal tumor, trauma and deformity patients,” said Doug King, senior vice president and president of Medtronic Spinal. “T2 Altitude is a new option for surgeons who perform corpectomies, including through the use of minimally invasive techniques.”

Medtronic’s spinal business is based in Memphis, Tenn.

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