FIM milestone for Proprio’s game-changer navigation platform.

from HealthCareBrew

Orthopedic surgeon Richard Bransford used the technology to operate on a patient with a slipped disc.

Surgeons in the US may soon be able to utilize Paradigm, a new navigation platform, for complicated spinal operations.

Proprio, a Seattle-based technology company, announced on October 16 that orthopedic surgeon Richard Bransford successfully used Paradigm for the first time in a spinal surgery, which was performed at the University of Washington Medicine Harborview Medical Center. The surgery marks the next step in bringing the device to market and gathering data for future uses of the technology.

“It’s an exciting time for us as a company to have those seven years now leading up to the first in-human use of the system,” Samuel Browd, Proprio’s co-founder and chief medical officer, told Healthcare Brew.

Bransford used the Paradigm technology to operate on a patient with a high-grade spondylolisthesis, or a slipped disc, and a foraminal stenosis, in which the space between the vertebrae begin to narrow.

The FDA-cleared device uses artificial intelligence (AI), augmented reality, and light field to help surgeons digitally map and visualize the surgery site. It also has the potential to decrease complications and make operations more efficient, Healthcare Brew previously reported.

Bransford called the spinal navigation platform a “game changer,” adding that the technology’s “real-time 3D imagery allowed us to visualize the patient’s anatomy in ways not previously available.”

Prior to this operation, Proprio trained surgeons at the University of Utah to use the technology on cadavers, Proprio’s co-founder and CEO Gabriel Jones said. The company plans to roll out a phased implementation of the technology in partner institutions such as the University of Washington, and run clinical trials to help Proprio gain insight into ways to further develop the technology, Browd said.

“As we acquire more data from cases that we’re doing, that’s going to inform the different modules and new things that we want to do,” Browd said.

While Paradigm was initially developed for use in spinal surgeries, the navigation platform can receive software updates so it can be used for other kinds of operations, such as knee replacement surgeries, Jones said.

But with each software update, the company will need to go through the FDA clearance process, which can be a “limiting factor,” Browd said.

“It’s very counterintuitive the way [the FDA has] done it historically. You write software, it’s locked—that’s what they approve,” Browd said. “The regulatory processes have to evolve with the technology as it’s coming.”

Still, the company expects to be able to push out software updates more quickly by “leveraging our own data to drive that flywheel faster than the industry has seen,” Jones said.

“It’s like watching Tesla push updates to the cars—it just totally revolutionized that entire industry. The same type of concepts are coming into surgery and we’re trying to enable that same kind of world for the operators that’s happening outside the [operating room],” Browd said.

Proprio expects to make Paradigm commercially available starting next year, and the company already has a two-year waiting list for the technology, Jones said.