SeaSpine has received CE Mark certification for its Cranial Module and Percutaneous Spine Module for the 7D FLASH™ Navigation System. This achievement expands the applications and functionality of the FLASH Navigation System for cranial surgery and minimally invasive spine surgery for the European market and additional global regions.
“We are thrilled to achieve CE marking on the expanded applications for cranial and spine,” said Beau Standish, President of Enabling Technologies at SeaSpine. “The speed, accuracy, and efficiency of our Cranial Module has had a significant impact on surgical workflow and has strongly resonated with our surgeon customers in the US. In addition, the Percutaneous Spine Module rounds out our game-changing spine portfolio and help to address an important part of the spine navigation market. We are eager to deliver the expanded portfolio of our FLASH Navigation System as we strategically roll-out the technology to Europe.”
The 7D FLASH Navigation System uses visible light to create a three-dimensional image for surgical navigation in just seconds, resulting in shorter and more efficient spinal and cranial procedures. It is the only regulatory approved image guidance system that utilizes this novel and proprietary camera-based technology, coupled with machine-vision algorithms, to eliminate the long-standing frustrations with legacy surgical navigation platforms. Specific to cranial applications, the FLASH Navigation System uses a completely contactless workflow, acquiring hundreds of thousands of virtual fiducials using the patient’s own anatomy, resulting in nearly instantaneous cranial registrations in almost any surgical position. The speed, accuracy, and efficiency of the FLASH Navigation Machine-Vision technology is intended to provide significant economic value and harnesses the true potential of image guided navigation for spinal and cranial surgery.
“The CE marking of these expanded applications is an important milestone as we look to further penetrate the European market with these best-in-class technologies,” stated Keith C. Valentine, President and Chief Executive Officer at SeaSpine. “The FLASH Navigation portfolio continues to deliver immense clinical value to the surgeon, hospital, and patient. We look forward to the continued development of our strong innovation pipeline to share with our customers from around the world and demonstrate our innovative philosophy and approach to improving surgical outcomes.”