TransMed7’s Concorde Soft Tissue Biopsy Devices Used in First Clinical Cases

TransMed7 LLC said its Concorde US devices have been used for the first time clinically in breast biopsy cases.

Part of the firm’s new Concorde family of vacuum-assisted, Single Insertion/Multiple collection (SIMC) Soft Tissue Biopsy devices, the Concorde US product was chosen by Dr. Michael Berry, an American Society of Breast Surgeons (ASBrS) member. He performed his procedure at the Margaret West Comprehensive Breast Center in Germantown, Tenn.

“We are delighted to announce the successful clinical utilization of our production level, minimally invasive Concorde breast biopsy devices as we formally roll out our commercial launch,” TransMed7 Co-Founder/Chairman Dr. James W. Vetter stated. “The real importance of achieving this new milestone is that it demonstrates unequivocally that our Zero5 core technology in both the SpeedBird and Concorde platforms of next generation biopsy devices has now been clinically confirmed with advanced benefits for the care of breast health patients in both United States and international markets.”

The Concorde US features a combined forward and side coring action, which is unique to Concorde’s advanced breast biopsy devices platform, and is designed to add a vital layer of precision, control, efficiency and confidence for biopsy procedure under advanced imaging modalities.
 
Similar to the SpeedBird device platform for breast health, the Concorde product family is based on TransMed7’s patented Zero5 work element composed of a fused, single element constructed from three hypotubes, laser cut and welded to form articulable twin cutter blades at the end of a rotating open tube, with the addition of an outer scoopula shield for the Concorde devices. 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.

“I was delighted to perform the first clinical cases using TransMed7’s new Concorde US ultrasound-guided soft tissue breast biopsy devices. Just a few coring passes were all that I needed for complete diagnosis in all of my Concorde cases—the core specimens were immense, full diameter and of surgical quality, and provided all of the lesion’s genomic marker information our team needed to provide a definitive diagnosis and plan for each of these patient’s therapeutic management,” Berry said. “Although the Concorde US device has a lot of advanced capabilities that allow us to imagine new procedures with its unique tissue shielding scoopula feature, I found it to be very intuitive and easy to use from the first time I picked it up, and I predict it will give physicians great confidence in approaching difficult cases just as it has in the cases I performed. I finished these biopsy procedures in an average of less than five minutes, which represents significant cost savings as well. This is my new favorite instrument.”
 
The Concorde platform of devices was developed by Vetter and his R&D team as a new mechanism for advanced breast biopsies. The devices consist of two models that are fully automated, selectively forward coring or combined forward and shielded side coring, vacuum-assisted, full fluid management, 10-14-gauge devices using proprietary tissue shielding technology at the working end of the coring needle. 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 LLC is a medical and technology-based organization focused on developing minimally-invasive medical devices that provide new solutions for doctors and patients. With particular emphasis on oncology, regenerative medicine, and cardiovascular disease, TransMed7 has developed a portfolio of next-generation platform devices.