SARASOTA, Fla. (March 27, 2024)- A new digital and personalized approach to spinal fusion surgery offers renewed hope to patients suffering from scoliosis and painful conditions caused by degeneration and deformities of the spine.
Sarasota Memorial Hospital is the first hospital in the region to offer the aprevo® implant, an FDA-cleared patient-specific spine implant used to replace damaged or diseased vertebral discs in the lumbar area of the spine. Unlike traditional off-the-shelf implants made to stock sizes, the aprevo device is personalized to fit the unique, bony ridges of each patient’s spine. By addressing the pathology and matching the anatomy of each individual patient, aprevo® may reduce complications, improve outcomes and lower the cost of care.
The key to this approach, according to Ashvin Patel, MD, an orthopedic surgeon and spinal implant specialist who brought the new technology to Sarasota Memorial, is the specialized imaging studies and 3D-printing technology that help the surgeon create a personalized surgical plan to replace a damaged disc with a patient-specific titanium implant designed to provide stability and optimizes alignment of the spine. The device is fused into place with a bone graft to allow adjacent vertebrae to grow into one long bone.
While stock implants are available in different sizes, Dr. Patel explains that this new process is very different. "We are now equipped to address the most challenging spinal malformations with implants that are specifically created to address each patient's individual needs. This represents another advanced treatment option to help our patients significantly reduce their pain and get back to the activities they enjoy.”
Manufactured by Carlsmed, Inc., the aprevo device is commercially available and covered by most insurance. Originally FDA-cleared approved to treat the lumber area of the spine, the device recently was granted a second “breakthrough device designation” by the FDA in September to develop implants for patients with cervical spine disease.
While the device is already FDA-cleared, Sarasota Memorial is participating in the COMPASS™ Personalized Spine Surgery Study, a multi-center post market observational registry that will track outcomes for two years for eligible patients who wish to enroll in the study.
“I am pleased we are able to provide this new, patient-specific surgical option for people with specific deformities and needs, and to take part in a study that measures its outcomes,” said Dr. Patel, who is the principal investigator of the observational study at SMH. “By tracking patient data, we can collaborate with institutions across the country utilizing this device and contribute to advances now and into the future.”
SMH produced this explainer video with Dr. Patel:
SMH Offering New Technology for Spinal Fusion Surgery from SMHCS on Vimeo.
About Sarasota Memorial Health Care System
Sarasota Memorial Health Care System is a regional referral center offering Southwest Florida’s greatest breadth and depth of care, with more than 1.5 million patient visits each year across its 2 hospital campuses, freestanding ER, and network of outpatient care centers. Its flagship 897-bed Sarasota hospital has been consistently recognized as one of the nation’s best, with superior patient outcomes and comprehensive network of outpatient centers. The public health system opened its second acute-care hospital, SMH-Venice, in November 2021 to serve the growing south Sarasota County region. For information, visit smh.com.