TransMed7, LLC Announces 510(k) Clearance by the U.S. FDA for its SpeedBird Soft Tissue Biopsy Device Platform
TransMed7, LLC announced today that the United States Food and Drug Administration (FDA) has cleared its 510(k) application for the company to market the SpeedBirdTM platform of soft tissue biopsy devices. “We are delighted to announce this 510(k) clearance by the FDA,” stated Dr. James W. Vetter, TransMed7 Co-Founder, and Chairman. “This is an important landmark as it puts TransMed7 in a position to attain its goal of developing critically needed, minimally-invasive medical technologies and getting them into the hands of clinicians for the benefit of their patients as quickly as possible.”
The SpeedBird platform is based on TransMed7’s patented Zero5TM work element composed of a fused, single element constructed from 3 hypotubes and forming rotating twin cutter blades. This element cores, severs, and provides a pathway to transport multiple tissue samples via a closed-circuit flush and vacuum mechanism into a detachable chamber. The SpeedBird platform is characterized by fully automated or manually operated, hand-held, ultrasound-guided, single insertion, multiple sample (SIMS) devices with a simple, cost-effective design, a single-use or reusable handle, and a forward coring action, intended to facilitate ease of use for rapid learning curve and adoption. Zero5 technology enables the SpeedBird devices to reliably and consistently obtain full-core, uniform-diameter samples with intact architecture from all of the various soft tissues.
“These devices are intended to address 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,” stated Dr. Edgar D. Staren, TransMed7 President and Executive Chairman of its Clinical and Scientific Advisory Board and its Business Advisory Board.
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 the vast majority of these are guided by ultrasound. Equipped with the Zero5 technology, TransMed7’s SpeedBird platform of products are ideally designed to address all minimally-invasive, ultrasound-guided, breast biopsies and with the goal of addressing the needs of surgeons, radiologists, and other clinicians who desire better minimally-invasive procedures through the use of next-generation, single insertion and multiple sample biopsy devices in a choice of sizes and which are designed to consistently and safely obtain higher quality biopsy samples from the breast.
In anticipation of 510(k) clearance, TransMed7 has been finalizing production and market introduction strategies for the SpeedBird product platform rollout for both domestic and international sales and distribution. Additionally, TransMed7 is continuing development of its portfolio of next-generation products based on innovative variations of its patented “Zero5” working element, which includes: ConcordeTM, a new platform technology for stereotactic and MRI based biopsy procedures and CardinalTM, a fine-needle core biopsy device for breast, thyroid, and lymph nodes. TransMed7 is also currently developing CygnetTM, a novel device designed to establish continued access for intervention including aspiration and biopsy of bone marrow and MartinetTM a revolutionary new minimal access device for complete removal of target tissue.
Eugene H. Vetter, TransMed7’s Co-Founder, and CEO, stated, “This is a bellwether moment in TransMed7’s history and represents the final milestone before the market launch of our SpeedBird 38, Universal, and SBU 99 soft tissue biopsy devices in the United States. We will be making a formal announcement upon our commercial launch which we expect to occur in the coming weeks.”