Implanet received FDA clearance to market its 3.5 mm, 4 mm, 4.5 mm and 6 mm JAZZ rods in the United States.
The company also obtained the CE mark in Europe for the same sizes. Here are five things to know:
1. The new sizes are in addition to JAZZ rods at the original size, 5.5 mm.
2. There have been more than 6,000 JAZZ devices implanted since the 5.5 mm rod launched in late 2013.
3. With the new sizes, the JAZZ system can be used to treat deformity and degenerative spinal disorders in adults. The original size was used for adolescent scoliosis.
4. The single-screw design provides band tension to ensure robust fixation. It's controlled by a simple and efficient tension instrument.
5. Papers published earlier this year show JAZZ's clinical efficiency in treating scoliosis. An independent micro-economic study published in March shows the clinical benefit of hybrid constructs consisting of screws and sublaminar implants.
"The economic advantage, combined with a comprehensive range of JAZZ implants, will enable us to achieve our objectives in a global environment where healthcare expenses are subject to more and more stringent controls," said Ludovic Lastennet, CEO of Implanet.