PORTOLA VALLEY, Calif.--(BUSINESS WIRE)--TransMed7, LLC announced today that the United States Food and Drug Administration (FDA) has cleared its 510(k) application for the company to market TransMed7’s new Concorde USTM and Concorde STTM soft tissue biopsy devices.
”This additional 510(k) clearance further broadens and differentiates TransMed7’s patented Zero5™ technology applicability in the Concorde platform, which combines the advantages of forward and side coring capabilities into a single needle platform, and that brings unique new procedural advances for breast biopsies,” stated Dr. James W. Vetter, TransMed7 Co-Founder and Chairman. “This is exciting not just for us and the many Breast and Gynecologic Surgeons and Interventional Radiologist who have been anticipating this major step forward in terms of ease of use, efficiency and clinical results, but most importantly for the patients who will benefit from this transformational technology we’ve developed with their well-being first in mind.” Dr. Vetter added, “We believe that it’s the right time for women to have better choices in their care, especially since standard breast biopsy devices have not fundamentally evolved over the last few decades. With our Concorde and SpeedBird biopsy device families we intend to offer them the most advanced devices in the world for gentler and more accurate breast biopsy procedures.”
TransMed7’s Concorde platform of Single-Insertion, Multiple Collection (SIMC) biopsy devices are all fully automated, vacuum assisted, full fluid management, 10 – 14 gauge devices that may be selectively configured for forward or combined forward and side coring biopsy procedures. Concorde ST is designed for stereotactic and 2D/3D tomosynthesis guidance biopsy procedures with full, built-in (console-replacing) capabilities. Concorde US is designed for ultrasound guidance for handheld use, but will also be available with an optional, reusable stage-mount adapter for Stereotactic and 2D/3D Tomosynthesis use.
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The Concorde devices use TransMed7’s Zero5TM system, similar to TransMed7’s SpeedBird devices, whose main coring component is a fused, single element constructed from 3 hypotubes forming rotating and articulating twin cutter blades, but in the case of the Concorde platform there is the addition of its unique, directional, tissue shielding mechanism for sensitive biopsy procedures, specifically designed for those procedures where a “round the clock face” sampling pattern is desirable by physician interventionists, particularly suiting the devices to stage-mounted procedures that breast interventionists commonly use to achieve concordance with the data obtained from mammography and other pre-procedure imaging studies with breast biopsy results. Like TransMed7’s SpeedBird devices, the Concorde devices gently core, sever, and provide a pathway to transport multiple tissue samples via a closed-circuit flush and vacuum mechanism into a detachable chamber. These capabilities enable the Concorde and SpeedBird devices to reliably and consistently obtain full-core, uniform-diameter samples with intact architecture from all of the various soft tissues.