4 Ways Spine Surgeons & Patients Can Benefit From New Technology
In a July 17 webinar titled "coflex®: The New MIS Non-Fusion Solution for Spinal Stenosis Approved for Your ASC," Hallett Mathews, MD, executive vice president and chief medical officer of Paradigm Spine, moderated a discussion of the company's newest device with a panel of spine surgeons.
The presentation panel consisted of John Peloza, MD, of The Center for Spine Care in Dallas; Michael Musacchio, MD, of The Center for Spine Care; Richard Salib, MD, of the Institute for Low Back and Neck Care in Minneapolis; and Glenn Keiper, MD, of KeiperSpine in Eugene, Ore.
The panelists discussed their experiences with the coflex® Interlaminar Stabilization™ technology for treating spinal stenosis after decompression.
Here are four benefits of adopting the coflex® device.
1. Motion preservation. Dr. Peloza has used the coflex® device in his spine practice. The motion preservation abilities of the device are effective, especially for patients with spondylolisthesis, he said. He used to do a minimally invasive decompression with rigid fusion, but the coflex® device has made the fusion largely unnecessary.
One of the surgical advantages of the device is that is gives the physician the ability to do a direct decompression first and stabilize the spine afterward, Dr. Musacchio said, thus reestablishing the motion segment.
"The direct decompression stands apart for me," he says. "It's very simple to do. The laminectomy is the entire procedure, and you are not increasing the patient's morbidity."
2. Outpatient surgery. The release of the device makes outpatient decompression and stabilization procedures possible to a degree other devices, such as dynamic rods, did not, Dr. Salib said. Previous devices for dynamic stabilization were not practical for outpatient surgery, he says.
The coflex® Interlaminar Stabilization™ technology brings less painful outcomes for patients and eliminates the need for overnight stays in most cases. The minority of cases, such as patients with most severe spondylolisthesis or major scoliosis curves, will need to remain hospital procedures. The ASC setting is also appropriate for procedures including minimally invasive fusion for the more unstable patient not indicated for the coflex® device, Dr. Keiper said.
Currently, only about 50,000 spine procedures are performed each year in outpatient settings. However, the coflex® device brings the potential for nearly 600,000 cases to be brought to surgery centers, Dr. Mathews said. Moving these procedures into the outpatient setting will also bring greatly reduced costs for facilities and for patients.
3. Quality outcomes. Paradigm Spine conducted a Level 1 prospective randomized controlled trial for formal FDA pre-market approval of the coflex® device. They received approval in October 2012 and launched the device this year. The trial involved 384 patients with a follow-up rate of two years. The researchers collected more than 375,000 clinical data points and found the device to cause less blood loss, quicker recovery time and longer-lasting relief, Dr. Mathews said.
Getting payers to recognize and reimburse for outpatient spine surgery is still an industry-wide challenge. However, the exceeding level of quality data and outcomes makes it easier to show panel members that the quality is undisputed and superior to most hospital outcomes, Dr. Musacchio said.
4. Low risk. Placing the implant is simple and requires very little learning curve for physicians, Dr. Peloza said. The placement also does not bring the risks associated with anterior or pedicle screw placement. It has also proved successful in preventing the return of spinal stenosis in the majority of patients.
View or download the Webinar by clicking here (wmv). We suggest you download the video to your computer before viewing to ensure better quality. If you have problems viewing the video, which is in Windows Media Video format, you can use a program like VLC media player, free for download by clicking here.
Download a copy of the presentation by clicking here (pdf).
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