Canary Medical Scores Breakthrough Designation for Spine Implant

Canary Medical’s new smart spine implant is one step closer to reaching the market. FDA granted the company 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 an interbody system for lumbar spinal fusion from L1-S1.

“Based upon our learnings with the smart knee implant and our scalable data platform, we believe that our technology can effectively address the major complications of spinal surgery and support patients recovering from the procedure,” said Bill Hunter, M.D., Canary Medical CEO.

The canturio lc will measure patient activity, a range of relevant spinal gait mechanics and the progression of fusion of the interbody construct. Transmitted data will be used to remotely monitor the progression of fusion and facilitate the early detection of clinically significant instability, partial fusion and non-fusion.

“The clinician and care team can review this information to determine if the patient is recovering as expected or falling behind,” Dr. Hunter said. “Ultimately, this allows for clinical intervention earlier than what would be traditionally provided and has the potential to significantly improve short- and long-term outcomes for spine surgery patients.”

Like the currently commercialized Canturio Tibial Extension (canturio te), the canturio lc is intended to collect various kinematic measures for at least 10 years and pool the data from each of the multiple parameters across the patient population. Canary’s data platform will provide clinicians with frequent, objective aggregate population data for each patient’s activity levels and kinematics to rank their performance versus their peers based on age group, gender and time since surgery.

Clinicians will be able to access and use this daily functional information to help determine whether to augment their in-office patient examinations or update care plans in the year following surgery.

“In the past, patients recovering from spinal surgery left the operating room and their clinician had no line of sight into their recovery progress until they returned to the office for post-surgical follow-up,” Dr. Hunter said. “This is only further exacerbated by poor compliance with patient follow-up visits. With the canturio lc smart interbody spacer, the clinician and care team will now be able to remotely monitor the patient’s progress between office visits with objective data that can augment their standard of care.”

Canary Medical also received 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 Smart Knee for patients who would benefit from a shorter tibial stem. The canturio se will be broadly commercially available later in 2024. The current 58-mm canturio te stem is still available for patients requiring a longer tibial stem.

JAV

Julie A. Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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