University of Virginia technology strengthens patients’ spines

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CHARLOTTESVILLE, Virginia (AP) – It might not turn you into a cyborg or a six million dollar man, but it could help you walk straighter and relieve skeletal back pain.

Doctors at the University of Virginia have started using a new 3D printed titanium back brace designed to fit individual patients with spinal deformities, whether from natural causes or trauma.

The spacer is designed to realign the spine into a more normal position and allow bone to grow through it to create a natural fusion in the spine.

Carlsmed, Inc., who creates the device, known as the aprevo implant, announced the first successful use of the implant in February of this year during surgery at the University of California Medical Center in San Francisco.


UVa doctors were also the first adapters of the device and were involved in its research and creation.

“It’s a spacer and it’s currently approved for spinal deformity cases, which are basically spinal misalignments,” said Dr. Justin Smith, professor of neurosurgery at UVa School of Medicine and director from the spine division of UVa medical center.

Smith said surgeries to correct misalignments often require cleaning up remnants of spinal discs, nature’s spacer devices in the spine. Titanium rods, plastic or titanium screws and spacers are used to consolidate the spine and realign it.

The idea is to straighten the spine, add spacers to keep it straight, and push the body bone out of the material to create a solid support where the disc once stood.

“We often put rods and screws to rebuild the spine in an attempt to get the bones that the rods and screws cover to either weld together or fuse,” Smith said. “The problem is, the rods and screws we put in are metal, and the metal is imperfect. If the bones do not come together securely through these (devices), then the metal has to endure the stress of the body indefinitely. The metal can then tire, fracture and fail or the screws can pull out or the rods can crack. “

An estimated 6 million adults have mild to severe spinal deformity and 1.6 million seek treatment for the condition, whether it’s surgery or other treatment, each year.

Before aprevo, most spacers were standard devices made from surgical plastics and particular sized metals. Although these implants have different heights to accommodate spines of different lengths, they are essentially preformed blocks.

Aprevo is different, said Smith, who worked with Carlsmed to develop the device.

“They tailor it to the exact shape of the bone surface above and below, so when it comes in it hugs the bone above and below and has maximum contact,” he said. declared. “It gives the best chance of healing and creating a strong fusion over time.”

Smith said a patient’s CT scans and standing X-rays are sent to Carlsmed, a medical technology company based in San Diego, California. The company uses the scanned and x-ray images to create a 3D model and designs the implant based on the model.

The modeling is accurate down to the bumps and texture of the surrounding bone.

“The company plans how the spinal alignment should be, and then designs the spacers to go between the bones to help maximize spinal correction,” Smith said. “Sometimes the implant will be a wedge shape instead of a block to help maximize spinal correction.”

The company then uses 3D printers to manufacture the custom-designed titanium implant.

“They often have an unusual shape. The surfaces are often irregular and rough and mimic bone surfaces, ”Smith said. “Then the company sends the design to the 3D printer where they can print whatever shape they want. “

In 2019, Carlsmed completed a merger with a Seattle-based spine imaging systems company to create the medical industry’s first personalized surgical workflow platform.

“Imaging for severe spinal deformities is primarily used for diagnostic purposes only,” said Mike Cordonnier, co-founder and CEO of Carlsmed in the 2019 announcement. “This enables the creation of surgical devices and plans in a model demand-based trading. This technological leap offers a giant opportunity to use meaningful data to improve patient care. “

In December 2020, the device and the company received approvals from the U.S. Food and Drug Administration. Two months later it was used in surgery.

“It’s kind of an exciting advancement,” Smith said. “In the past, we just put on a block that didn’t necessarily offer optimal correction of the deformity, wasn’t really in optimal contact with the bones, and didn’t really promote the healing process like the new implant does.

The technology to make the implants was not readily available before the development of 3D printing for titanium structures, Smith said.

“Being able to 3D print titanium cages is relatively new. It has only been around for a few years, ”he said. “Before this technology, we couldn’t really create the unusual surfaces and shapes that match each patient. “

Smith said the device promotes rapid healing and recovery and creates fewer surgery complications and reduces the need for additional surgery

“The two goals of spinal deformity surgery are to get realignment and ultimately to solidify the bones, which actually helps achieve both goals,” he said. “It’s an exciting step forward and it’s quite exciting that UVa is at the forefront.”

In July, the company announced that it was working with the International Spine Study Group Foundation to study adult spine deformity and collect data on surgical treatment with similar devices.

Long-term outcome data will be collected to determine to what extent, if any, the devices improve patient outcomes and reduce surgical complications.

“There is a general trend towards more personalized care in medicine. It makes sense that the implants we would use for spinal surgeries also become more personalized, ”said Smith. “I have the feeling that more and more surgeons will be using the implant. The technology is good and it is going to be beneficial.


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