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The Dreaded Call. We Didn’t Get It All.

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 Full Impact of Breast Cancer Re-Excisions

1 in 8 women will be diagnosed with breast cancer in her lifetime.³

2/3
patients with early-stage breast cancer have a lumpectomy⁴

21%
of lumpectomies
require a re-excision surgery
to get clean margins¹²

Patients experience increased pain, delay in adjunct treatment, compromised cosmesis, and emotional trauma⁴^, ^5-7
54% increased risk of complications¹²
+$21k costs¹²
10%-36% convert to mastectomy⁴

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.

S-Series OCT

Changing the margin imaging paradigm

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.

[accordnote id=”oct” label=”High-resolution OCT” popup=”Using light, images have 10x higher resolution than ultrasound and X‑ray and 100x higher than MRI for visualization at the cellular level.”]

[accordnote id=”mv” label=”Margin Visualization” popup=”Resolution is optimized for visualizing microscopic tissue structures down to 2mm, ideal for reviewing surgical margins.”]

[accordnote id=”non” label=”Non-Invasive and Non-Destructive” popup=”Tissue is entirely preserved for histopathology and device does not come in contact with the patient or enter the sterile field.”]

[accordnote id=”rti” label=”Advanced Software” popup=”ImgClear algorithm now reduces scan time by 28% and increases the signal-to-noise ratio (SNR) by up to 441%, streamlining workflow and producing clearer, more detailed images to help surgeons identify regions of interest.”]

[accordnote id=”ol” label=”Orientation Labeling” popup=”Label and capture images of surgical margins on all six planes to convey accurate orientation for pathology.”]

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The S-Series OCT has a general indication and has not been evaluated by FDA for specific uses. More information here.

Future AI in Clinical Development

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.

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Perimeter 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.

Clarity Surgeons Have Never Seen Before

Scroll through the interactive OCT volume to see the difference with your own eyes

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The OCT Difference

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.

Benefits of OCT include:

Subsurface images of excised tissue microstructures for hard-to-detect disease
Ultra-high-resolution imaging at 10X the resolution of X-ray and ultrasound at 2mm depth
Correlates directly with histological appearance of tissue structures in post-surgical pathology
Incredibly fast and portable, allowing for intraoperative tissue visualization in any OR

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Benefits to Surgeons

See It In Action

How OCT Works

Ready to learn more about Perimeter?

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