7D Surgical Expands Spine and Cranial Technology Offering

7D Surgical has announced important additions to its cranial and spinal product lines. The company has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a medical device license from Health Canada for its Cranial Biopsy Kit, which allows neurosurgeons to use image guidance to accurately target brain lesions during needle biopsy procedures. In its effort to support a wide range of surgical instruments, 7D Surgical is also announcing the commercial release of its Universal Tracking Kit, which spine surgeons can use to track and visualize almost any rigid surgical instrument on the MvIGS system, including third party vendor taps and screwdrivers.
 
“7D Surgical has successfully transitioned from a start-up organization to a growth company, having launched more than 33 MvIGS programs since our full commercial release a little over a year ago. We are very proud of our team for commercializing these latest products in the spine and cranial markets,” said Beau Standish, CEO of 7D Surgical. “2020 will be another break out year for our Machine-Vision innovations and continued North American and international expansion.” 
 
The 7D Surgical MvIGS system utilizes completely new camera-based technology and machine vision algorithms to eliminate the long-standing frustrations with legacy surgical navigational platforms. The system uses only visible light, eliminating the patient and staff exposure to intraoperative radiation which is common with older technologies. This results in a nearly instantaneous patient registration in almost any surgical position.  
 
“We have completed more than 1,500 clinical cases with the 7D Surgical System and the feedback from our surgeon users has been tremendous. I am excited to offer these new technologies to our customer base which expand the functionality of the MvIGS system while maintaining our clear advantages in speed and reduced radiation exposure to operating room staff and patients,” said Brian Stuart, vice president of Sales and Marketing at 7D Surgical.
 
Last month, Toronto-based 7D Surgical and SeaSpine Holdings Corporation entered into a strategic alliance agreement to integrate and co-market their combined product offerings, as well as develop SeaSpine-specific instrumentation optimized to work with 7D Surgical’s flagship Machine-vision Image Guided Surgery (MvIGS) platform for spinal and cranial surgeries. The agreement allows SeaSpine to offer a customized, best-in-class navigational solution to its hospital and surgeon customers on a non-exclusive basis. 
 
Keith Valentine, SeaSpine president and CEO, said: “We have been extremely impressed by 7D’s ability to improve surgical workflow and the timing of our collaboration is ideal. With over 12 product launches expected in 2020, including limited commercial launches of our initial 3D-printed offerings and full commercial launches of our foundational Mariner system in additional market segments, such as MIS and deformity, that give us access to over $2 billion in new market opportunities, the introduction of 7D’s navigation system further enhances our ability to offer a complete, integrated and seamless procedural solution in spine. Equally important, by using visible light, rather than fluoroscopy, the 7D Surgical System does not expose operating room personnel to unnecessary, additional radiation.” 
 
Standish said: “SeaSpine’s commitment to innovation and the development of complete procedural solutions combining spinal implants and orthobiologics matches perfectly with our surgeon-centric focus on improving operating room workflows. With SeaSpine’s differentiated suite of product offerings, recent capitalization and their expanding customer base, we believe this alliance will greatly expand our commercial reach by providing our hospital customers with a complete surgical solution and a capital-efficient means of acquiring the MvIGS system.”