Toronto-based 7D Surgical, Inc. has received CE Mark certification for its Machine-vision Image Guided Surgery (MvIGS) system for posterior spine surgery. CE marking allows the company to market the system in Europe and other regions that recognize the certification.
7D Surgical’s MvIGS System Receives CE Mark
1 min read Premium comments
Secondary#7dsurgical#mvigs#imageguidedsurgery
The system provides navigated surgery support for spine procedures using camera-based technology, rather than infrared used in systems like Medtronic’s StealthStation. The technology allows for faster setup and instrument registration, as well as segmental registration of each vertebrae to pre-operative CT. The company claims that patient registration takes less than 20 seconds, Segmental registration reduces the need for intraoperative CT after adjusting spine alignment, which typically renders previous images useless for navigation purposes. This cuts down on OR time and radiation exposure to the patient and surgeons needed for intraoperative imaging.
Brian Stuart, the chief revenue officer for the company, described the benefits of segmental registration, “Accomplishing true segmental registration with our Flash™ Technology has had a tremendous impact on the safety and efficacy of the system, as it results in high navigational accuracy in mobile areas of the spine and complex anatomy.”
Chief Executive Officer Beau Standish expressed his excitement in a press release from the company, “We are extremely excited to achieve our CE Mark. With successful launches already underway in the United States, Canada, Australia, New Zealand and the Caribbean, we are eager to begin expanding the MvIGS technology into the European spine market.” He added his gratitude to the company’s employees, “We are very proud of our team for accomplishing this important milestone and we are continuing our growth and expansion into international markets.”
7D Surgical, Inc. has also received 510(k) clearance for its cranial application for biopsy, cranial surgery, and ventricular catheter placement. In February, 2020, the company entered a distribution agreement with SeaSpine Holdings Corporation to co-market both companies’ portfolios and develop SeaSpine-specific instrumentation optimized for the MvIGS system. The agreement will likely help 7D capitalize on the new certification by using SeaSpine’s existing distribution network.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.