Cancer surgeons have long recognized the challenge of achieving clean margins while preserving healthy tissue during surgery. Traditional intraoperative imaging does not have the resolution to see microscopic features associated with cellular-level disease, like DCIS.2 And it’s several days or weeks before pathology reports on margin status are available. If pathology shows positive margins, patients must typically return for another procedure due to cancer left behind.
Perimeter’s OCT technology delivers the clinical edge healthcare providers need to improve patient satisfaction and offer the most advanced care.
The S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. The safety and effectiveness of these uses has not been established. More information here.
Our flagship product, Perimeter S-Series OCT (Optical Coherence Tomography) is a pioneering medical imaging system that delivers ultra-high-resolution margin visualization of excised tissue specimens in the operating room.
The S-Series OCT has a general indication and has not been evaluated by FDA for specific uses. More information here.
Recognizing the unmet need, particularly in the field of breast cancer margin visualization, Perimeter has a randomized, controlled, multi-site, pivotal study (RCT) underway. The clinical trial is designed to evaluate Perimeter B-Series OCT with ImgAssist AI against the current standard of care and assess the impact on re-operation rates for patients undergoing breast conservation surgery.
Learn MorePerimeter OCT B-Series is not available for sale in the United States. CAUTION – Investigational device. Limited by U.S. law to investigational use. Perimeter received U.S. FDA Breakthrough Device Designation for its Optical Coherence Tomography (OCT) Imaging System with ImgAssist AI in April 2021.
Optical Coherence Tomography (OCT) technology, developed out of MIT in 1991, has been successfully used in ophthalmology, cardiology, GI, and dermatology for decades. Clinicians rely on OCT’s ultra-high-resolution imaging power to view microscopic subsurface tissues to help them make more informed clinical decisions.
Now, Perimeter is revolutionizing intraoperative margin visualization with its patented wide-field OCT technology that stitches OCT images together, creating the ability to scan larger tissue specimens and correlate microstructures to key features seen in post-op Pathology when determining margin status.