Culicchia Neurosurgeon Performs First Anterior Spine Fusion Using 3D aprevo® Personalized Implant
Culicchia Neurosurgeon John Steck was the first in Louisiana to use breakthrough aprevo®3D technology to design a patient-specific spinal implant for an Anterior Lumbar Interbody Fusion (ALIF) procedure.
We recently hosted the 2023 Canaccord Genuity Musculoskeletal Conference in Las Vegas leading up to AAOS. The conference showcased 31 innovative, privately held companies in our coverage universe primarily focused on orthopedics. Coming out of those meetings, we have increased conviction in the level of innovation emerging from the private companies and the potential for differentiated solutions to enter the market over the next several years (either through an IPO or M&A via the larger strategic players). We came away impressed with the level of innovation, clinical data, and commercial progress many of these companies have accomplished over the past year, particularly against the challenges of the pandemic.
Dr. Christopher Battista, spine surgeon at Lowcountry Orthopaedics and Sports Medicine, has become the first spine surgeon in South Carolina to achieve a 3D-printed patient-specific implant procedure. As the first surgeon in the state to complete this procedure, Dr. Battista used a personalized implant to replace a diseased disc that was causing the patient debilitating pain.
The first patients have been enrolled in a clinical trial evaluating the outcomes of patients who underwent spine surgery with aprevo, Carlsmed’s patient-specific spine implant.
The study, known as “Compass” — clinical outcome measures in personalized aprevo spine surgery — is a multicenter post-market prospective observational registry that will collect data on patients treated with aprevo devices and track outcomes over two years.
Long-term outcomes data will be collected to analyze aprevo devices — Carlsmed’s patient-specific interbody for the treatment of adult spinal deformity — in improving outcomes and reducing complications.
In December, the FDA granted aprevo its breakthrough device designation, which expedites the time taken to reach clinical trials.
I have spent the last two decades collaborating with surgeons to develop devices and systems for improved patient outcomes focused primarily on three A’s of orthopedics: Arthrodesis, Arthroplasty, and Arthroscopy. I am now focused on the fourth A: automobiles. That is right, automobiles.
I have noticed many parallels between the evolution of automobiles and orthopedic devices over the past 100 years. In the 1920s, Henry Ford perfected mass production techniques to create a car for the masses, built on an assembly line with interchangeable parts. Ford produced nearly 15 million Model T’s and established the blueprint for great American car companies to follow. This revolution in assembly line-based mass production became the poster child of Industry 2.0 and lasted until the early 1980s.
News 12 is told people with severe back pain who need multiple surgeries can receive an implant to make it a “one-and-done” process.
Dr. Vijay Yanamadala of the Ayer Neuroscience Institute Spine Wellness Center in Westport is the first neurosurgeon to perform the special spine surgery. “He had already had a lumbar fusion surgery, he has osteoporosis,” says the doctor.
At least 1.6 million U.S. adults seek treatment for spinal deformities every year.
The Rationale for Personalized Interbody Devices is a literature review of published research about the potential benefits of patient specific interbody devices. Over 30 studies describe the benefits related to personalized geometry and endplate fit, which may help surgeons achieve sagittal and coronal alignment goals more reliably.
When the 65-year-old man came to the Spine Wellness Center, he had already undergone several surgeries on his spine and even had a spinal cord stimulator implanted, yet was told he would likely feel pain in his right leg for the rest of his life.
He saw Dr. Vijay Yanamadala, system medical director of spine quality and surgical optimization for Hartford HealthCare’s Ayer Neuroscience Institute and director of spinal deformity at the Spine Wellness Center in Westport. Dr. Yanamadala had recently seen a colleague in California demonstrate success inserting a new device between vertebrae in the spine to help ease pain and increase mobility. It was the first use of the device called aprevo® by Carlsmed, a medical device technology company. He suggested it to the man.
Neurosurgeon Dr. Vijay Yanamadala is with Ayer Neuroscience Institute Spine Wellness Center/St. Vincent’s Medical Center explains the latest surgery he recently performed “patient specific spine surgery.”
Neurosurgeon Vijay Yanamadala, MD, has performed the second procedure worldwide that uses a titanium, 3D-printed device meant to fuse spinal vertebrae and ease chronic pain, News12 reported.
The limited-release device, Aprevo, is made by medtech company Carlsmed, which uses data analytics to personalize the implants for each patient, according to an Aug. 2 Hartford HealthCare news release.
Aprevo is an FDA-designated breakthrough device that is patient-specific. It’s also designated as a transformative new device by Medicare.
“Offering Aprevo to our patients represents an important step to advancing surgical outcomes in spinal care and exemplifies our commitment to offering our patients the best care possible,” said Roland Kent, MD, co-owner of the hospital and co-founder of Northwest Specialty Hospital’s Axis Spine Center in Coeur d’Alene, Idaho.
Aprevo is an FDA-designated breakthrough device that is patient-specific. It’s also designated as a transformative new device by Medicare.
“Offering Aprevo to our patients represents an important step to advancing surgical outcomes in spinal care and exemplifies our commitment to offering our patients the best care possible,” said Roland Kent, MD, co-owner of the hospital and co-founder of Northwest Specialty Hospital’s Axis Spine Center in Coeur d’Alene, Idaho.
CONNECT WITH US