L&K Biomed, South Korean medical device manufacturer received 510(k) clearance from the FDA in September 2019 for Accelfix-XTP which is a height expandable cage of the Anterior To Psoas Approach. Accelfix-XTP is the only height expandable cage with a curved shape for lumbar spine with ATP surgical approach.
Currently, lateral cages in the market generally have a rectangular shape, and ATP cages have a rectangular shape or similar shape to the existing ALIF cage. There exists a possibility of a risk, such as contralateral nerve hitting, if the conventional rectangular shaped cage is used for lateral surgery approach.
AccelFix-XTP has a unique and patented curved shape which is opposite to the curved shape of a TLIF cage, and the data shows Accelfix-XTP can prevent such contralateral side nerve hitting because of its unique curved shape as described above.
Therefore, L&K Biomed plans to update usability, which has been considered only for existing ATP surgery approach, through a clinical Data Collection to insert Accelfix-XTP as a lateral approach and supplement it so that it can be applied to lateral surgery as well. The Clinical Data Collection for this usability will be conducted in hospitals in the US, and L&K Biomed is looking for healthcare providers who wish to participate in the Clinical Data Collection for this purpose.
<Lateral Curved Expandable Cage>
L&K Biomed Website: http://www.lnkbiomed.com/en/
L&K Biomed email: mkt@lnkbiomed.com