Canary Medical, a medical data company focused on the development and commercialization of its patented implantable sensor technology and complementary data and analytics ecosystem, today announced FDA’s grant of “Breakthrough Device” designation1 for its Canturio Lumbar Cartridge (canturio lc) with 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-S. The cartridge is designed to provide objective kinematic data from the implanted medical device during a patient’s post-surgical treatment of symptomatic degenerative disc disease.
The 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.
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 each patient’s 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 and/or to update their patient’s care plan in the year following surgery.
This news is preceded by 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 for patients whose physician believes would benefit from a shorter tibial stem. The canturio se will broadly be commercially available later in 2024. The current 58-mm canturio te stem is still available for patients requiring a longer tibial stem.