(ChemotherapyAdvisor)–The FDA has issued an Approvable Letter for MarginProbe, a device that provides real-time assessments of the adequacy of surgical margins during breast cancer lumpectomies, pending finalization of a required post-approval study’s design, Dune Medical Devices, Inc., has announced.
“Having completed our discussions with FDA related to product labeling, the Post Approval Study is the only remaining issue to be resolved prior to final approval,” said Daniel Levangie, Dune’s CEO.
Cancer cells left in the post-lumpectomy margins around resected breast tumors can dramatically increase the risk of recurrence. In between 30% and 60% of cases, suspected positive-margins result in repeat surgery. The MarginProbe System will allow intraoperative assessment of surgical margins for the presence of tumor tissue, the company reports.
“The Dune MarginProbe System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins of the ex-vivo lumpectomy specimen following primary excision,” states the firm’s executive summary, posted on the FDA’s website.
The device “utilizes electromagnetic waves to characterize human tissue in real time, providing intraoperative information on the malignancy of the surface of the ex-vivo lumpectomy specimen,” the company’s summary states.
“It is intended for use on freshly excised tissue within 20 minutes of tissue excision” and is meant to be used alongside standard methods “such as intraoperative imaging and palpation” to improve indicated re-excision rates during lumpectomy, the summary states.
The MarginProbe PMA received expedited review status in April 2011 following the FDA’s determination “that the MarginProbe System represents a breakthrough technology that may offer clinically meaningful advantage in providing intraoperative indication of margin status as an adjunct to standard of care.”