Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced that it has submitted a De Novo 510(k) application to the U.S. Food and Drug Administration (FDA) seeking marketing clearance for its Breast Cancer Locator (BCLTM) System. A medical device can be designated for the De Novo pathway when it offers novel technology with a reasonable assurance of safety and effectiveness for the intended use, and there is no legally marketed predicate device.
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The BCL System is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing detailed guidance regarding tumor shape, size, and location to surgeons. It is intended to help surgeons achieve clear tumor margins and improve the workflow of breast conserving surgery. A supine MRI with the breast positioned in its surgical position for greatest accuracy is first performed at the patient’s hospital and the imaging data is sent to Cairn Surgical, where a customized 3D-printed form – the BCL – is designed and produced using the imaging data to match the unique dimensions of that patient’s tumor and breast. During surgery, the BCL is used by the surgeon to provide valuable references during tumor excision.
“FDA clearance of the BCL System would give surgeons access to precise information about each breast tumor that has never before been available to them,” said Cairn Surgical CEO David Danielsen. “Knowing more about the tumor shape, size, and location in the supine position has the potential to improve a surgeon’s ability to remove it in its entirety the first time, spare women from repeat surgeries, and save costs to the healthcare system associated with unnecessary procedures. We thank the entire Cairn Surgical team and our dedicated clinical partners who enabled us to reach this important milestone, and look forward to the prospect of transforming breast cancer surgery with our novel technology.”
The company has completed its U.S. pivotal trial, and results will be presented at the annual meeting of the American Society of Breast Surgeons in April. Included in the FDA submission are these pivotal trial results, as well as earlier BCL System data published in the Annals of Surgical Oncology1 showing that the BCL System enabled breast surgeons to successfully remove breast tumors with negative margins in 94% of patients and safety outcomes comparable to typical breast conserving surgery.
