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.

Christopher Ames, M.D., director of spinal tumor and spinal deformity surgery at the University of California San Francisco Medical Center performed the first-in-man use of a patient-specific, digital to device spine surgery implant. Dr. Ames was assisted by Patrick Maloney, M.D. The supplier, San Diego, California-based Carlsmed, Inc. has brand-named the new system “aprevo™”.

The FDA granted clearance of 40 orthopedic and spine devices in December.

17 spine devices receive FDA clearance in December

The Aprevo device by Carlsmed has potential to better restore movement and alleviate pain, for those suffering from malalignment of the spine…

Spine-facing medical technology company Carlsmed is collaborating with the International Spine Study Group Foundation to collect surgical data on personalized interbody devices.

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.

Mike Cordonnier is CEO and co-founder of Carlsmed, a San Diego based Med Tech Company. Carlsmed’s Corra system utilizes predictive analytics to create patient-specific surgical plans and 3d printed implants to improve patient outcomes for spine surgery…

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.

SAN DIEGO–(BUSINESS WIRE)–CARLSMED, Inc., a San Diego-based medical technology company, today announced that it has completed a merger with Seattle-based spine imaging system company Precisive Surgical to offer the industry’s first personalized surgical workflow platform. The terms of the merger are not disclosed. The system will enable earlier surgical intervention delivering personalized implant devices to patients with complex, multi-level spinal deviation of alignment. The expected results include better patient outcomes and quality of life, reduction in the use of opioids for pain management, as well as decreased overall surgical costs to the patient, surgeon and hospital/surgery center.

Westport doctor says patients with chronic back pain need no longer worry now that a specific device exists.
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.

(WTNH) — An innovative technique allowing doctors to tailor to spine surgery and a patient’s need.

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.

Dr. Albert Wong was selected as a guest speaker for the second annual aprevo® Power Forum hosted by Carlsmed, a global medical technology company. The two-day event was held on August 4-5, 2023, at The Seabird & Mission Pacific Hotel in Carlsbad, CA, featuring presentations, panel discussions and networking opportunities for surgeons.

The aprevo® implant, the only spine surgery device to receive the Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), is now being offered at UVA Health. One of the lead surgeons working to foster its development, Justin Smith, MD, Director of the UVA Neurosurgery Spine Division and co-director of the UVA Spine Center, recently introduced the technology, making UVA the first hospital in the eastern U.S. to use this transformative technology.

WHAT YOU SHOULD KNOW: Even though AAOS moved their conference from the usual March timeframe to account for an earlier spike in CV-19 cases, a combination of Delta and holiday weekend timing impacted physician attendance. This did not stop industry from highlighting numerous technology and software that continue to position orthopedicsforshifting clinical adoption in the ASC, increasing use of robotics and virtual reality, and more advanced implant technologies(i.e.,smart-implants) that provide data and insight regarding patient recovery (among other technologies at the show). …

POST FALLS, Idaho, Sept. 29, 2021 /PRNewswire/ — Northwest Specialty Hospital and Axis Spine Center have become the first specialty hospital in the U.S. to provide personalized spine surgery with aprevo® patient-specific surgical plans and spine fusion devices. Unlike traditional approaches, aprevo® devices are tailored to the precise medical situation of each patient. Aprevo® has been designated by the US FDA as a Breakthrough Device and by Medicare as a Transformative New Device. No other technology available for spine surgery has received either of these designations.

Post Falls, Idaho-based Northwest Specialty Hospital is the first specialty hospital in the U.S. to provide spine surgery with the Aprevo device, according to a Sept. 28 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.

Post Falls, Idaho-based Northwest Specialty Hospital is the first specialty hospital in the U.S. to provide spine surgery with the Aprevo device, according to a Sept. 28 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.