The Perimeter S-Series OCT device provides real-time, cellular-level margin visualization in the OR, enabling surgeons to act in the moment and elevate control of their outcomes.
The S-Series OCT is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.
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.ed.
A Prospective Multi-Center, Randomized Clinical Trial to Assess the Positive Margin Rate of Breast-Conserving Surgery (BCS) With or Without the Aid of an Intraoperative Optical Coherence Tomography-Artificial Intelligence (OCT-AI) System
WHEN: Saturday, May 3, 9-10 a.m. — Scientific Oral Presentations 3
PRESENTATION HIGHLIGHTS:
PRESENTED BY PRIMARY PRINCIPAL INVESTIGATOR:
Alastair Thompson, MD, FRCS(Ed), FACS
Section Chief of Breast Surgery and Professor,
Baylor College of Medicine;
Breast Cancer Program Leader,
Dan L. Duncan Comprehensive Cancer Center
To reserve your spot, click here.
When: Exhibit Hours
Where: Booth 422; Medical Affairs
*Perimeter B-Series OCT is not available for sale in the United States. CAUTION – Investigational device. Limited by U.S. law to investigational use.
*The S-Series OCT is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.
*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.
For more information on unapproved/off-label uses, visit perimetermed.com/disclosures or contact medicalaffairs@perimetermed.com.
**B-Series OCT is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer aided detection algorithm which identifies and marks focal areas suspicious for breast cancer and is used concurrently with physician interpretation of the images. The device is intended for use in conjunction with other standard methods for evaluation of the margins of an excised lumpectomy specimen during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer. Perimeter B-Series OCT is not available for sale in the United States. CAUTION – Investigational device. Limited by U.S. law to investigational use.
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