US-based privately-held medical technology company TransMed7 has announced the first-in-human use of the commercial production version of its Concorde US devices.
The Concorde US devices are a part of its family of vacuum-assisted, single insertion/multiple collections (SIMC) soft tissue biopsy devices.
The first cases using Concorde US devices have been performed by Dr Michael Berry, at the Margaret West Comprehensive Breast Centre in Germantown, Tennessee, US.
TransMed7 said that the soft tissue biopsy device delivered a combined forward and side coring action, which is unique to its Concorde family of advanced breast biopsy devices.
They add a crucial layer of precision, control, efficiency, and confidence for biopsy procedures under advanced imaging modalities, said the company.
Michael Berry said: “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.
“I found it to be very intuitive and easy to use from the first time I picked it up – and I predict that it will give physicians great confidence in approaching difficult cases just as it has in the cases I performed.”
The Concorde family of devices have been developed based on the company’s patented Zero5 work element, a fused, single element constructed from three hypotubes.
The work element is laser cut and welded to form articulable twin cutter blades at the end of a rotating open tube, along with an added outer scoopula shield.
TransMed7 said that the element gently penetrates, cores, severs, and provides a pathway to transport multiple tissue samples through a closed-circuit fluid management and vacuum system into a detachable chamber.
The Zero5 forward coring technology is said to enable the devices to consistently obtain full-core, uniform-diameter samples with intact construction from all different soft tissues.
The company designed Concorde US device for either ultrasound guidance for handheld use or use with an optional, reusable, stage mount adapter.
TransMed7 co-founder and chairman James W Vetter said: “We are delighted to announce the successful clinical utilisation of our production level, minimally invasive Concorde breast biopsy devices as we formally roll out our commercial launch in this first quarter of 2023.
“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.”
