Stryker Interventional Spine has received 510(k) clearances from the US Food and Drug Administration (FDA) for Venom RF cannula and electrode combination and11g iVAS balloon system.
The Venom RF cannula and electrode combination contains an alternative configuration at the distal end, allowing the electrode to protrude from a side port opening at the base of the active tip.
It is designed to provide an effective and minimally invasive treatment for facet joint pain.
The 11g iVAS balloon system is a minimally invasive solution that allows to streamline access and improve procedural control and efficiency when treating vertebral compression fractures.
The resultant action achieves a larger lesion without increasing gauge size, allows for more proficient anesthesia delivery, and reduces tissue damage along the path to the target lesion zone.
The 11g iVAS is a complete system for performing vertebral augmentation procedures and matches the least invasive balloon option in the market.
The 11g iVAS balloon system has a 20% smaller cross-sectional area than a traditional 10g system and a 47% smaller cross-sectional area than the original 8g vertebral augmentation equipment.
Addition of these products enhances Stryker’s position as being a single source for minimally invasive spine solutions.