Dive Brief:

• Viseon has received 510(k) clearance for a device that captures images of the sites of spinal surgeries for display on monitors in operating rooms.

• The device, the Voyant System, is designed to improve on the microscopes and loupes used today by freeing surgeons from the need to reposition and refocus the imaging equipment.

• The clearance marks the culmination of a strategy Viseon set in motion when it spun out of minimally-invasive surgical device company Rebound Therapeutics.

Dive Insight:

Minimally-invasive spine surgery offers multiple benefits over open traditional spine surgery. The procedures can cut the risk of cosmetic damage, blood loss, harm to muscles and infection. As with less invasive procedures in other parts of the body, the application of the approach to spinal problems can also shorten post-surgery recovery times.

These benefits have led surgeons to apply minimally-invasive techniques to the treatment of lumbar spinal stenosis, degenerative disc disease and other conditions that affect the spine. However, Viseon thinks there is ample scope to further increase uptake of minimally-invasive techniques.   

“We believe the primary factor contributing to spine surgeons’ slow adoption of minimally invasive spine surgery has been inconsistent outcomes driven by the limited or lack of direct access to and visibility of the surgical anatomy. Traditional capital-intensive surgical microscopes and loupes have been in use for many years,” Viseon CEO Jeffrey Valko said in a statement.

Valko thinks the Voyant System is a simple alternative to surgical microscopes and loupes that could help to drive increased adoption of minimally-invasive spine surgery. The system features a single-use retractor that captures images. This retractor is connected to a reusable controller that enables the surgical team to make adjustments during the procedure.

Viseon spun out of Rebound early last year to advance the device and went on to raise $5 million to fund its activities in September. The company topped up its bank balance with a follow-on offering of undisclosed size earlier this month.

Armed with the cash, Viseon aims to carve out a niche in a market that looks set to change regardless of its intervention. Last week, a survey by Leerink found 20% of U.S. hospital administrators plan to spend more on robotic equipment that facilitates minimally-invasive spinal surgery, such as Mazor’s Renaissance.