Thursday, May 30, 2024
Canary Medical, a medical data company specializing in implantable sensor technology, has announced that the FDA has granted Breakthrough Device designation to its Canturio® Lumbar Cartridge (canturio®lc) and Canary Health Implanted Reporting Processor (CHIRP®) System.
The canturio®lc is designed for lumbar spinal fusion procedures from L1 to S1, and it provides objective kinematic data from the implanted device during post-surgical treatment of symptomatic degenerative disc disease. This data will be used for remote monitoring of fusion progression and early detection of instability, partial fusion, and non-fusion.
Similar to the Canturio® Tibial Extension (canturio®te), the canturio®lc collects kinematic measures for at least 10 years and aggregates data from multiple parameters across the patient population.
Canary’s data platform offers clinicians frequent, objective aggregate data on patients' activity levels and kinematics, enabling performance comparisons based on age group, gender, and time since surgery. This information helps clinicians augment in-office examinations and update care plans during the first year after surgery.
“This marks the fourth consecutive Breakthrough Device designation for a Canary Medical product by the FDA, an unprecedented achievement in our industry,” said, Founding Member and CEO of Canary Medical. “Following our smart knee, hip, and shoulder applications, this smart spine designation is a significant milestone.
It is our first smart spine offering and our first Breakthrough Device designation outside the large joint space. We are excited about the potential benefits for future lumbar spinal fusion patients and look forward to partnering with an innovative spine company to bring this technology to market.”
This news follows the 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®. The canturio®se will be available in 2024, while the 58-mm canturio®te stem remains available for patients needing a longer tibial stem.
Source: globenewswire.com
