Canary Medical Earns FDA Breakthrough Status for Smart Spine Lumbar Cartridge

Canary Medical has gained the FDA’s grant of “Breakthrough Device” designation for its Canturio Lumbar Cartridge (canturio lc) with the Canary Health Implanted Reporting Processor (CHIRP) System. The canturio lc is intended for use with a Lumbar Interbody System for lumbar spinal fusion from L1-S1. 
 
The cartridge is designed to provide kinematic data from the implanted medical device during post-surgical treatment of symptomatic degenerative disc disease. The data is used to remotely monitor the progression of fusion, and facilitate the early detection of clinically significant instability, partial fusion, and non-fusion.
 
Bill Hunter, Founding Member and CEO of Canary Medical said, “The approval of canturio lc is the fourth time in a row that a Canary Medical product has received Breakthrough Device designation from the FDA, an unparalleled accomplishment in our industry. First, we received the breakthrough designation for our smart knee, followed by hip and shoulder applications, and now, our smart spine application. I would like to congratulate the entire Canary team for their continued excellence.”
 
Canturio lc is similar to the Canturio Tibial Extension (Canturio te) and is intended to collect a variety of kinematic measures for at least 10 years and pool data from multiple parameters across the patient population.
 
Canary’s data platform provides clinicians with frequent, objective aggregate population data for each patient’s activity levels and kinematics to rank each patient’s performance versus their peers based on age group, gender, and time since surgery. Clinicians will be able to use this information to help determine whether to augment their in-office patient examinations and/or to update their patient’s care plans in the year following surgery.
 
“It is also notably Canary’s first smart spine offering and the Company’s first FDA Breakthrough Designation outside of the large joint space, which is the momentum we intend to maintain. Based on the results we have seen with our current “smart” knee product, this designation is also great news for future lumbar spinal fusion patients. We look forward to securing an innovative spine partner to help bring this cutting-edge technology to market,” he continued.
 
This precedes Canary Medical’s recent FDA clearance of the Canturio Smart Extension (canturio se), a 30mm version of the smart tibial stem extension integrated with Zimmer Biomet’s Persona IQ – The Smart Knee.