TransMed7, LLC announced today the availability of Concorde, the stereotactic table variant of its SpeedBird Biopsy Device Platform
“We are delighted to announce a letter-to-file regarding ConcordeTM, the stereotactic table variant of our FDA-cleared SpeedBirdTM soft tissue biopsy device platform,” stated Dr. James W. Vetter, TransMed7 Co-Founder and Chairman. “Like the original announcement on June 19 that the FDA had cleared our 510(k) application to market SpeedBird, this is another important step as it furthers TransMed7’s goal of developing, under the guidance of experts, critically needed, simpler to use, minimally-invasive medical technologies and distributing them into the hands of clinicians for the benefit of their patients.”
The Concorde device platform is based on TransMed7’s patented, proven Zero5TM technology, comprising a fused, single element constructed from three hypotubes and forming its multifunctional tip. This single element tip is capable of cycling between configurations to perform the functions of an ideal biopsy procedure under various guidance modalities. Without requiring a sharp needle tip to advance through tissue or the need to first fire a sharp tip through or past the target lesion, the Concorde tip can approach, core, sever and transport multiple samples of a target lesion via a closed-circuit flush and vacuum mechanism into a detachable, proprietary, tissue preservation and transport chamber. Concorde is a fully automated, forward coring, vacuum-assisted, single insertion, multiple-sample (SIMS) device with a simplified, cost-effective design, a single-use, fully equipped handle, which obviates the need for a console, that simplifies the entire specimen acquisition and storage procedure, which greatly facilitates ease of use for a rapid learning curve, and lowers costs for widespread adoption. Zero5 technology enables the Concorde device to reliably and consistently obtain full-core, uniform-diameter samples with intact architecture in all types of soft tissues regardless of compliance factors.
“These devices are intended to address the many problematic issues that have been identified by highly experienced, expert colleagues in the field and are associated with current biopsy devices, including the firing of razor sharp and potentially traumatic needle tips with their required needle tip dead space, as well as tissue compliance variabilities that fundamentally limit biopsy specimen quantity, quality and consistency,” stated Dr. Edgar D. Staren, TransMed7 President and Executive Chairman of its Clinical and Scientific Advisory Board and its Business Advisory Board. “In its letter-to-file, TransMed7 documents how Concorde’s handle is enhanced for placement on a stereotactic or 2D/3D biopsy gantry, including the provision to activate an automatic partial cycle pause and full-cycle resumption, further simplifying documentation of post-core needle position.”
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 a minimally-invasive technique and more than 300,000 of these are performed by stereotactic methodology. Equipped with the Zero5 technology, developed utilizing years of and ongoing guidance by, experts in the field, TransMed7’s SpeedBird and Concorde platforms of products are designed to ideally optimize all minimally-invasive breast biopsies. The goal of these technologies is to enhance the ability of surgeons, radiologists, and other specialists to better serve their patients with minimally-invasive procedures through the use of simpler, more inherently precise and cost effective, next-generation, single insertion and multiple-sample biopsy devices designed to consistently and safely obtain higher quality biopsy samples from the breast.
TransMed7 has been finalizing production and market introduction strategies for the SpeedBird and Concorde rollout for both domestic and international sales and distribution. Additionally, TransMed7 is continuing development of its portfolio of next generation soft tissue biopsy and delivery products based on innovative variations of its Zero5 working element to apply to other fields of use that likewise have significant unmet needs, including: CardinalTM, a fine-needle (21 gauge and smaller) core biopsy device for breast, thyroid, and lymph nodes, with particular application for the pediatric population; and HeronTM, a single insertion, multi-sample device with primary aim at the prostate biopsy market but also for liver and kidney biopsy. TransMed7 is also currently developing CygnetTM, a novel device designed to take advantage of Zero5’s proprietary methodology to create a continuously accessible pathway for other interventions such as aspiration and biopsy of bone marrow and delivery of treatment agents; and MartinetTM a revolutionary new minimal access device for complete target lesion removal.
Eugene H. Vetter, TransMed7’s Co-Founder and CEO, stated, “This is another bellwether moment in TransMed7’s history that marks, in addition to SpeedBird 38, Universal, and SBU 99 ultrasound-guided breast biopsy devices, the final milestone leading to the market launch of our Concorde stereotactic and 2D/3D tomosynthesis-guided breast biopsy devices in the United States which we anticipate in the coming weeks.”