Canary Medical announced today that it received FDA breakthrough device designation for its Canturio lumbar cartridge.
Canturio LC with the Canary Health Implanted Reporting Processor (CHIRP) works with a lumbar interbody system for lumbar spinal fusion from L1-S1. The company designed it to provide objective kinematic data from an implanted medical device. It collects the data during the post-surgical treatment of symptomatic degenerative disc disease.
Transmitted data helps to remotely monitor the progression of fusion and facilitate the early detection of clinically significant instability.
With the breakthrough platform, Canary Medical builds upon its Canturio tibial extension. Canturio LC collects kinematic measures for at least 10 years and pools data from multiple parameters across the patient population. Canary Medical’s data platform gives clinicians frequent, objective aggregate population data. Clinicians can then use this to help augment in-office examinations or update patient care plans.
This marks the latest potential advance for Canary Medical, which already has a presence in the orthopedic implant space. The company hopes to make smart implants the next big thing. It recently received FDA clearance for an extension for the tibial system, which integrates with Zimmer Biomet’s Persona IQ smart knee. The company expects broad commercial availability later this year.
“It is notably Canary’s first smart spine offering and the company’s first FDA breakthrough designation outside of the large joint space, which is momentum we intend to maintain,” said Dr. Bill Hunter, CEO of Canary Medical. “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.”