First Clinical Use of TransMed7’s Soft Tissue Breast Biopsy Devices

TransMed7 LLC announced that the first of the vacuum-assisted, Single Insertion – Multiple Collection (SIMC) breast biopsy procedures utilizing its SpeedBird 38 soft tissue biopsy device was successfully performed by Dr. Richard Fine, a surgeon and former chairman and president of the American Society of Breast Surgeons (ASBrS). 
 
Dr. Fine commented, “Image-guided breast biopsy using the TransMed7 vacuum-assisted, SIMC devices involves minimal setup, was very easy to perform because of its gentle, positive action and extreme ultrasound visibility, was very well tolerated by the patient, and took only a few moments to complete. The core specimens were of excellent quality and I acquired exactly what I targeted and needed for our team to plan the next step for the patient’s therapeutic treatment on the basis of correlation and pathology of the specimens. The device yielded superior cores with extreme efficiency and ease of use.”
 
Dr. Edgar D. Staren, TransMed7 president and executive chairman of its Clinical and Scientific Advisory Board and Business Advisory Board, stated, “We specifically designed and developed the SpeedBird and Concorde platforms to address and overcome 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.” He added, “I’m very proud of our Team, and having been intimately involved in the development of these new breakthrough technologies brings me great personal satisfaction and pride.”
 
The company’s U.S. Food and Drug Administration (FDA)-cleared SpeedBird platform (SpeedBird 38, SpeedBird Universal, SpeedBird Universal 99, and Sparrow) and Concord platform are based on TransMed7’s patented Zero5 work element composed of a fused, single element constructed from three hypotubes and forming rotating twin cutter blades. This element gently penetrates, cores, severs, and provides a pathway to transport multiple tissue samples via a closed-circuit fluid management and vacuum system into a detachable chamber. Zero5 technology enables these devices to reliably and consistently obtain full-core, uniform-diameter samples with intact architecture from all of the various soft tissues. It was developed as an entirely new mechanism intended to deliver superior results while also lowering costs, and to facilitate ease of use for rapid learning curve and adoption.
 
“We are delighted to announce the successful utilization of our new minimally invasive breast biopsy devices,” stated Dr. James W. Vetter, TransMed7 co-founder and chairman. “The real importance of achieving this milestone is that it demonstrates unequivocally that our Zero5 core technology has now clinically confirmed its transformational nature for the care and benefit for patients world-wide. This result proves that our plan to apply Zero5 technology to all of our next generation device platforms, adapted for various applications all over the body, is an achievable benchmark. These include our Heron, ThunderBird, Cardinal, and Phoenix platforms among others still to come, as well as the robotic instrument applications that we derive from each of them.”
 
The SpeedBird platform includes four models of hand-held, ultrasound guided, vacuum assisted, full fluid management, SIMC devices with simple, extremely cost-effective designs based on the common Zero5 forward coring technology with 10, 12, and 14-gauge core needle sizes. SpeedBird 38 is designed for fully automated cycling (tissue coring, part-off, and transport); SpeedBird Universal is designed for manual coring length control and automatic tissue transport; SpeedBird Universal 99 is designed for manual coring length control and automatic tissue transport, but features a reusable handle and replaceable needles, resulting in a lower cost ideal for emerging international markets; and the new Sparrow device, which is designed for manual coring length control and automatic tissue transport, is intended to become the ultimate Single Insertion – Single Sample (SISS) “snapgun”- type device “terminator.”
 
The Concorde platform of two device models, also based on adapted Zero5 technology, are fully automated, selectively forward or combined forward and side coring, vacuum-assisted, full fluid management, 10 -14-gauge devices. The Concorde ST device is designed for stereotactic and 2D/3D tomosynthesis guidance biopsy procedures with full, built-in (console-replacing) capabilities. The Concorde US device is designed for either ultrasound guidance for handheld use or with an optional, reusable, stage mount adapter for Stereotactic and 2D/3D Tomosynthesis use.
 
All of these devices can leverage VacuPac, which avoids the need for external tubes and power cords, and VacuTower, TransMed7’s proprietary, portable, external vacuum devices, sold separately.
 
Eugene H. Vetter, TransMed7’s co-founder and CEO, stated, “Coming immediately on the heels of our announcement of FDA 510(k) clearance for our Concorde platform, which complements the 510(k) clearance already received for its SpeedBird partner platform, the successful use of these devices now proves that our goal of exploiting our patented Zero5 technology to provide the world’s most extensive range of transformational, next generation, minimally invasive device platforms for biopsy procedures and interventional solutions is not only real, but imminent – patients should finally be able to look forward to this next generation of devices replacing the decades-old technologies currently being used on them, and we’re working very hard to make that a confirmed reality right now.”