PORTOLA VALLEY, Calif.– TransMed7, LLC announced today that the “First in Human” clinical case of the commercial production version of a Heron™ XPS device (a member of the new Heron™ family of vacuum-assisted, Single Insertion / Multiple Collection (SIMC®) Soft Tissue Biopsy devices) was successfully performed by Dr. Edgar Staren, a surgical oncologist with the US Oncology network and a Clinical Professor of Surgery at the University of Arizona Phoenix, College of Medicine.
Dr. Staren commented, “I was confident to perform the first clinical biopsy procedure using TransMed7’s new Heron™ XPS ultrasound-guided soft tissue biopsy device on a challenging case that otherwise would have required an open surgical biopsy procedure because of the proximity to major blood vessels and other sensitive structures as well as the need to obtain adequate tissue for histopathologic, molecular and other studies. The forward coring Heron™ device allowed me to precisely position the device in relation to the lesion because of its clear ultrasound visibility all along the path from the skin, to and through the lesion, and ensure that the samples taken were just what I was targeting. Three coring passes were all that I needed for complete diagnosis – the core specimens were immense, full diameter, high quality, and provided all of the lesion’s relevant information for our team to provide a definitive diagnosis and plan for the patient’s therapeutic management.” He added, “I predict that the ease of use and performance of the Heron™ devices will give physicians great confidence in approaching biopsies of the liver, kidney, prostate, lymph nodes and others, as well as difficult cases that otherwise would require open surgical biopsy procedures. The whole biopsy procedure was finished in less than 5 minutes, which represents a significant cost savings as well.”
Similar to the SpeedBird™ and Concorde™ device platforms for breast health, the Heron™ platform of devices for soft tissue biopsies and interventional procedures for nearly all organs (excluding lung at present) and soft tissue outside of the breast is based on and adapted from 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.
Dr. James W. Vetter, TransMed7 Co-Founder and Chairman stated, “We specifically designed and developed our Heron™ platform to provide the most extensive breadth of advanced capabilities available in the world, for soft tissue biopsy and interventional procedures across many clinical applications. Each of the Heron™ platform devices is capable of accepting any of the drop-in needle sets in the full range of 12, 14, 16, and 18 gauge needles matched to any of four standard needle lengths to provide a full range of options for procedures involving highly vascular organ systems, and where complex neuro-vascular bundles located along the pathway to the target sites are present such as in the prostatic capsule region, and likewise in organs and other sensitive soft tissue structures, particularly where ease of guidance and ease of device manipulation are considered essential, enabling capabilities. We intended from the start to make the Heron™ platform the most universal set of biopsy devices in the world, enabling interventionists all over the globe to quickly expand the scope for minimally invasive alternatives to organs and areas within organ systems that simply would not have been advisable prior to the introduction of the Heron line of instruments.”
The Heron™ platform of soft tissue biopsy devices includes three models of hand-held, ultrasound guided, vacuum assisted, full fluid management, SIMC® devices. The Heron™ XP device model is designed for fully automated cycling (tissue coring, part-off, and transport), and features an optional side shielding scoopula in short or long version. The Heron™ XPK and XPS full featured models are designed for manual coring length control and automatic tissue transport.
The Heron™ platform also includes a new device model, the Heron™ RO model, designed for direct integration into a robotic surgical system for advanced surgical procedures of the future, including robotic prostate BPH symptom relief interventions. Similar to the Heron™ XP model, it is a fully automated, selectively forward coring or combined forward and shielded side coring, vacuum-assisted, full fluid management, biopsy or tissue debulking device. The Heron™ RO model features full remote control capabilities through the use of a Remote Control Unit (RCU) or Wireless Control Unit (WCU) for maximum adaptability to an advanced robotic surgical system.
Eugene H. Vetter, TransMed7’s Co-Founder and CEO, stated, “The Heron Platform of devices was originally developed to target the need for advanced biopsy capabilities and other procedures for the prostate, kidney and liver. We’ve expanded that indication to match its FDA granted 510k clearance for all soft tissue outside of lung, but also deliberately excluding breast interventions for which our SpeedBird™ and Concorde™ devices were specifically developed and are superbly matched. The Heron™ devices are currently 510k cleared for 10 to 14 gauge needles, and we expect to receive FDA clearance for 16 and 18 gauge needle sizes as well before year end. The Heron™ platform devices will provide the most advanced capabilities for biopsy devices featuring needle sizes from 12 to 18 gauge. Our next generation Cardinal™ devices, currently under development, will complete the advanced biopsy device spectrum with 19 to 23 gauge needles, thus providing the first true Fine Needle Core Biopsy (FNCB) capabilities anywhere in the world.”
TransMed7 anticipates participating in the next Radiological Society of North America (RSNA) meeting in Chicago, IL where we will report expanded clinical results from multiple centers using our FDA – cleared Heron™ soft tissue biopsy devices for prostate, liver, kidney and other soft tissue biopsies outside of the field of breast health, as well as for Prostate BPH symptom relief procedures.
