SeaSpine has announced that it has received FDA 510(k) clearance of its 7D Percutaneous Spine Module for minimally invasive surgery (MIS).
This represents a new application and increased functionality for its 7D Flash Navigation System, says SeaSpine, and follows the company’s recent acquisition of 7D Surgical, a Toronto-based firm that develops optical technologies and machine vision-based registration algorithms for surgical navigation.
SeaSpine is currently preparing a limited release of the Percutaneous Spine Module in the third quarter.
Beau Standish, president of enabling technologies at SeaSpine, said: “We are extremely excited to achieve FDA clearance and eager to deploy our Percutaneous Spine Module. This new application will help address an important part of the spine navigation market and will nicely round out our Flash Navigation Spine portfolio.
“We anticipate this MIS application to be a valuable enhancement for both ambulatory surgery centres and hospitals. I’m very proud of what our team has accomplished thus far, but this is still just the beginning of where we will take our machine vision technology in the future.”
The 7D Flash Navigation System uses visible light to create a three-dimensional image for surgical navigation in seconds, which is expected to result in shorter and more efficient spinal procedures.
According to SeaSpine, it is the only regulatory-cleared image guidance system that utilises this novel and proprietary camera-based technology, coupled with machine-vision algorithms, to eliminate the long-standing frustrations with legacy surgical navigation platforms. The speed, accuracy, and efficiency of machine-vision technology is intended to provide significant economic value and harnesses the true potential of image guided navigation surgery.
Keith Valentine, president and chief executive officer at SeaSpine, added: “We are very happy with the integration of 7D Surgical into the SeaSpine family.
“This is the first new product introduction as a combined team and continues to demonstrate our innovative philosophy and approach to improve spine surgery and deliver clinical value to the surgeon, staff, and patient. We believe that participation in the full continuum of care for each patient will deliver clinical value and accelerate our market-share taking strategy.”
The Spine Module has FDA 510(k) clearance, Health Canada MDL approval, and CE Mark for spinal navigation. The Percutaneous Spine Module has FDA 510(k) clearance for spinal navigation. The Cranial Module has FDA 510(k) clearance and Health Canada MDL approval for cranial navigation.