FDA provided clearance of an expanded indication for Tenon Medical’s Catamaran Sacroiliac (SI) Joint Fusion System for use in augmenting thoracolumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion.
Catamaran received initial clearance in 2018, when it was noted as the first patented single-implant SIJ fusion system to employ a posterior approach for minimal tissue disruption.
“Recognition from the FDA of Catamaran’s use to augment spinal fusion has been a long-term goal of Tenon during the development of the Catamaran SI Joint Fusion System,” said Steve Foster, Chief Executive Officer of Tenon Medical. “As our clinical experience grows and the data from our MAINSAIL clinical trial emerges, it is clear that we achieve an authentic fusion of the SI Joint in a safe, reliable and efficient manner. We believe this can be an important tool in the complex spine surgeon arsenal to support the base of a multi-level fusion.”
FDA provided clearance of an expanded indication for Tenon Medical's Catamaran Sacroiliac (SI) Joint Fusion System for use in augmenting thoracolumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion.
FDA provided clearance of an expanded indication for Tenon Medical’s Catamaran Sacroiliac (SI) Joint Fusion System for use in augmenting thoracolumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion.
Catamaran received initial clearance in 2018, when it was noted as the first patented single-implant SIJ fusion system to employ a posterior approach for minimal tissue disruption.
“Recognition from the FDA of Catamaran’s use to augment spinal fusion has been a long-term goal of Tenon during the development of the Catamaran SI Joint Fusion System,” said Steve Foster, Chief Executive Officer of Tenon Medical. “As our clinical experience grows and the data from our MAINSAIL clinical trial emerges, it is clear that we achieve an authentic fusion of the SI Joint in a safe, reliable and efficient manner. We believe this can be an important tool in the complex spine surgeon arsenal to support the base of a multi-level fusion.”
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