The first surgery performed with the Minimus Spine Triojection System was performed in Italy.
Here are five quick facts about the procedure:
• Dr. Josip Buric performed the procedure alongside Drs. Luca Coro and Luca Rigobello
• Triojection involves controlled delivery of ozone gas to a herniated disc to relieve pain
• Patients undergo the procedure with local anesthetic
• Each procedure takes around 15 minutes
• Dr. Buric reported Visual Analogue Scale scores dropping from eight to 10 before surgery to zero to two within a week after surgery
"Although I have been using the ozone for some 20 years, the Triojection System takes ozone delivery to a herniated disc to a new level," says Dr. Buric. "Triojection gives a much higher level of confidence that the procedure minimizes the infection risk and ensures that a consistent concentration is administered to the disc. The initial follow-up on the first four patients shows early results to be very good."
The system offers a single injection to relieve leg pain related to herniated discs. The procedure can be done at a lower cost to the healthcare system than surgery, and allow patients to avoid an invasive procedure. Now, Minimus Spine plans to move forward with plans for a multicenter, randomized, postmarket study in Europe.
"That study is designed to compare the outcomes of Triojection to surgical discectomy," said Minimus Spine President and CEO David Hooper, PhD. "We will be looking to these results to provide the basis for discussions related to market adoption, reimbursement and the U.S. regulatory pathway. While we have had significant interest from distributors around the world, we are prioritizing this clinical study as our key value driver next year."