Canary Medical, known for its expertise in implantable sensor technology and data analytics, has received FDA "Breakthrough Device" designation for its Canturio® Lumbar Cartridge (canturio®lc) and Canary Health Implanted Reporting Processor (CHIRP®) System.
This device is designed for use in lumbar spinal fusion from L1 to S1, providing objective kinematic data during post-surgical treatment of degenerative disc disease.
It aims to facilitate remote monitoring of fusion progression and early detection of issues like 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, aggregating data across patient populations.
“This marks fourth consecutive FDA Breakthrough Device designation, a significant achievement. They smart knee, hip, shoulder, and now spine applications have all been recognized. Commend the entire Canary team for their excellence.
"This designation is particularly notable as it represents our first smart spine product and our first Breakthrough Device outside the large joint space.
Building on the success of smart knee product, this is promising for future lumbar spinal fusion patients. They look forward to partnering with a leading spine company to bring this advanced technology to market.
Canary Medical also recently received FDA clearance for 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 commercially available later in 2024, alongside the existing 58mm canturio®te stem.
Source: https://www.globenewswire.com/news-release/2024/05/29/2889827/0/en/Canary-Medical-s-Smart-Spine-Lumbar-Cartridge-Granted-FDA-Breakthrough-Device-Designation.html
