CARLSBAD, Calif. (KGTV) — A perfect fit — that’s the goal of a medical research firm in Carlsbad developing a new approach to spine fusion surgery that has the potential to restore movement, and alleviate pain, for hundreds of millions of people who suffer from varying degrees of scoliosis.
“Everything starts with a single patient,” said Mike Cordonnier, an engineer with a extensive background in medical tech.
Four years ago, Cordonnier founded Carlsmed, which has developed a personalized surgical device called Aprevo.
“As you can see, this is an asymmetric device,” Cordonnier said as he held an Aprevo disc, which easily fits in the palm of the hand. “What it does is it fits the natural anatomy of the vertebral body. You can see it lock into place.”
The Aprevo discs are designed to replace the five vertebral discs within the lumbar region of the spine — that’s the lower back area that supports the body — to help restore alignment and alleviate pain related to scoliosis and other malformities. This type of surgery has been in use for decades, but the Aprevo disc and the Carlsmed approach is unique.
“We get medical imaging from every patient,” explained Cordonnier, “So that we can map [the anatomy of] every patient exactly.”
The Aprevo disc is then designed on a computer to fit the individual patient.
Cordonnier continued, “Then we get that patient to where they should be digitally. Send that to the surgeon. They approve it, and then we create the devices just for that patient.”
The discs are formed on a 3-D printer to be an exact match for the contours of the spine where they’ll be placed.
Previous methods have relied on discs of various generic sizes which were trial an error, and often required invasive contouring of bone to be set in place.
“I've had family members with multiple spine surgeries,” recalled Cordonnier. “Not the best outcomes.”
Those sub-par results are part of what Cordonnier said inspired him to come up with a better approach.
He proudly positions an Aprevo disc within a demonstration model of a spine.
“The planes of the vertebral body are now aligned,” said Cordonnier. “The stress distribution throughout the spine is balanced.”
And that exact fit, Cordonnier said, means a greater chance of success and reduced need for follow up procedures. Thus, lowering potential discomfort and cost.
Some 200 patients have received the Aprevo discs so far and studies are underway to gauge long term outcomes. Cordonnier said Aprevo also has FDA approval and is covered by insurance.
Meanwhile, Carlsmed has been honored with the Spine Technology Award, by the North American Spine Society in Boston.