Local spine surgeon co-develops new FDA-approved lumbar disc replacement

Local spine surgeon co-develops new FDA-approved lumbar disc replacement

Dr. Rolando Garcia

Dr. Rolando Garcia, a Miami-based spine surgeon and the first surgeon in Florida to perform spinal disc replacement surgery, has co-developed the first lumbar disc replacement to be approved by the Federal Drug Administration (FDA) in over 10 years.

ActivL is the new generation of lumbar disc replacement and the first artificial lumbar disc with intelligent motion technology. Made up of chromium endplates that affix to the patient’s vertebrae with bone-sparing spikes for stabilization, it has a mobile ultra-high molecular weight polyethylene core that supports rotational movement similar to the movement of the healthy lumbar spine.

The ActivL was approved by the FDA in June of 2015 after an extensive five-year, multi-center national clinical study that followed 324 patients. Dr. Garcia, a spine surgeon at Orthopedic Care Centers, not only co-developed this technology but was also the co-lead investigator in the FDA trial. He performed the first ActivL surgery in the United States.

Dr. Garcia currently is the only spinal surgeon in South Florida, and one of a select few throughout the country, to offer ActivL as an option for lumbar disc replacement. He also has performed the most of these surgeries in the state of Florida.

One of the primary causes of lower back pain is degeneration of the intervertebral disc. Conservative treatment ultimately fails in over 4.5 million patients, and of these, some 500,000 undergo surgery of the lumbar spine. Up until now, spinal fusion surgery has been one of the only surgical options available. However, this surgery has a varying success rate and can result in stiffness of the spine as well as other long-term complications such as pain, spinal stenosis, increased stress on the spine, disc herniation, joint arthritis and accelerated degenerative changes in the disc.

The ActivL provides an alternative to spinal fusion and is made up of flexible plastic which allows it to recreate the forward and backward motion of the spine while providing relief from lumbar pain. It also comes in a variety of sizes so that the surgeon can select the size and angulation that best fits the patient’s unique anatomic and physiologic requirements. Most importantly, patients experience improved outcomes over fusion by quicker recovery, improved mobility, reduced pain, and a reduced need for additional surgery and medication.

“With a fusion, we can most of the time hit triples, certainly doubles in terms of pain relief. But it’s unusual for patients to undergo spinal fusion and for you to hit a home run, meaning the patient gets complete pain relief,” Dr. Garcia said. “With lumbar disc replacement, when it’s well done, we are able to hit home runs. We’re able to make preserve the patient’s motion and function where postoperatively they have absolutely no pain.”

The ActivL disc replacement is placed into the spine via a small incision in the front of patient, through the abdomen usually just left of the belly button. This minimally invasive approach minimizes the cutting of muscle, provides the patient with a better fit for the implant and speeds up recovery significantly.

The procedure is performed to alleviate back pain due to lumbar degenerative disc disease and/or to remove pressure from the nerves from lumbar disc herniations. Patients who have mainly back pain or a combination of back pain and leg symptoms are the best candidates for an ActivL lumbar disc replacement.

Patients do not need to wear a brace after surgery and experience significant relief of their back pain within days. Most patients return to light activities around two week’s post-surgery and unrestricted activity in about two months.

Dr. Garcia’s has maintained a practice for over 20 years at The Orthopedic Care Center located at 21000 NE 28 Ave., Suite 104 in Aventura.

For more information on Dr. Rolando Garcia and the ActivL lumbar disc replacement, visit drrolandogarcia.com. To schedule a consultation, call 305-937-1999.

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