Therapy Areas: Oncology
TransMed7 Shows First Clinical Use of SpeedBird Breast Biopsy Devices for Commercial Launch
9 August 2022 - - US-based medical and technology-based organization TransMed7, LLC has announced the first clinical cases of the final commercial production version of the Sparrow device (a member of the new SpeedBird family of vacuum-assisted, Single Insertion / Multiple Collection (SIMC) Breast Biopsy devices), the company said.

This was successfully performed by Dr. Edgar Staren, a surgeon and former president of the American Society of Breast Surgeons (ASBrS).

The SpeedBird and Concorde device platforms are based on TransMed7's patented Zero5 work element composed of a fused, single element constructed from 3 hypotubes, laser cut and welded to form articulable twin cutter blades at the end of a rotating open tube.

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 forward coring 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.

The SpeedBird platform of Breast Biopsy devices 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 and SpeedBird Universal 99 are designed for manual coring length control and automatic tissue transport (SpeedBird Universal 99 further 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 and is intended to become the ultimate "Terminator" of the Single Insertion Single Sample (SISS limited to only one sample for each insertion) "snapgun" devices being used on a majority of patients TODAY.

The Concorde platform of two device models, also based on adapted Zero5 technology, are fully automated, selectively forward coring or combined forward and shielded side coring, vacuum-assisted, full fluid management, 10-14-gauge devices.

The Concorde ST device is designed for stereotactic and 2D/3D tomosynthesis guidance breast 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.

TransMed7 anticipates participating in the next Radiological Society of North America meeting in Chicago, IL; the next American Society of Breast Surgeons (ASBrS) meeting in Boston, Massachusetts; and the next Society of Breast Imaging meeting in Washington, DC, where we will report expanded clinical results from multiple centers using our FDA-cleared SpeedBird and Concorde biopsy devices for Breast Health.

TransMed7, LLC is a medical and technology-based organization focused on the highly efficient development of innovative, minimally invasive medical devices aimed at providing new solutions for doctors and their patients.

With particular emphasis on oncology, regenerative medicine, and cardiovascular disease, TransMed7 and its team of clinicians, scientists, and engineers have developed a portfolio of next-generation platform devices that are expected to be market leaders in their targeted fields of medicine.
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