TransMed7, LLC Announces 510(k) Clearance by the U.S. FDA for its Concorde US
(Ultrasound) and Concorde ST (Stereotactic) Soft Tissue Biopsy Device Platform

Portola Valley, CA –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 US TM and Concorde ST TM 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 Radiologists 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.

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.

“Our new Concorde and SpeedBird devices are intended to address the many problematic issues associated with current biopsy devices including difficulty visualizing the needle tip with real-time imaging modalities; sharp and potentially traumatic needle tips, limitations in biopsy specimen quantity and quality, and restrictions on tissue type and needle gauge – I’ve been there and I know what a giant step forward our devices represent,” stated Dr. Edgar D. Staren, TransMed7 President and Executive Chairman of its Clinical and Scientific Advisory Board and its Business Advisory Board.

According to recent publications, approximately 1.7 million breast biopsies are performed per year in the U.S. Nearly 1.4 million of these biopsies are performed by minimally-invasive biopsies, but over half of those biopsies still involve decades-old Single Insertion-Single Sample (SISS) biopsy device technology in an effort to lower costs. The use of SISS devices means that for each biopsy sample taken, the device must be inserted into the breast, and then withdrawn with the sample, which must be removed before the device is again inserted into the breast for a new sample. Furthermore, these devices, by virtue of their design, frequently use a spring-loaded “firing” mechanism that is designed to overcome the limitations of such device’s abilities to obtain adequate tissue for subsequent pathologic examination.

With this in mind, Dr. Staren added, “We’re also very proud to announce the addition of a new device – “Sparrow” – to the already 510(k) cleared SpeedBird family, which, like all of our devices, is a fully functioning Single Insertion-Multiple Collection (SIMC™) device, but designed specifically with the goal of eliminating all Single Insertion -Single Sample (SISS) devices from the breast biopsy market. We feel this goal is indeed realistic given the extremely efficient cost of production we can attain with all of our devices and this device in particular, so it’s time for women to finally have premium choices for minimally invasive breast biopsy procedures without being asked to make any sacrifice for cost savings.”

Eugene H. Vetter, TransMed7’s Co-Founder and CEO, stated, “The SpeedBird and Concorde devices are finally ready for rapid production scale-up and market entry for better biopsy options for women, but that’s still just the first step in our plan to provide the world’s most extensive range of transformational, and even micro-invasive device platforms for biopsy procedures and interventional solutions, including a range of new tools for robotic applications for the future. The next steps will include our new “Cardinal” Fine Needle Core Biopsy devices – which were designed for breast, lymph nodes, thyroid and pediatric procedures; along with “Heron”- a new device platform designed for far gentler, safer and more effective prostate biopsy and benign prostate hypertrophy tissue removal for men.” Mr. Vetter further added, “It’s time for the world to become aware of what we have been and are doing – the “quiet revolution” we have started is rapidly producing advanced technologies that patients should and will demand, so stay tuned for more announcements in the near future.”


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