Concorde Breast Biopsy Device Platform

The Concorde product platform of single-insertion, multiple sample (SIMS) breast biopsy devices has been generated to fulfill the needs of breast surgeons and radiologists for next-generation, cost-effective devices designed to safely, reliably, and consistently obtain high-quality biopsy samples from all tissues encountered in the breast during specialized procedures using stereotactic, digital breast tomosynthesis, or MRI.

Design Features:

  • Breast biopsy devices based on TransMed7’s Zero5 technology and developed for stereotactic and MRI based breast biopsy procedures.
  • Full, built-in capabilities eliminating the need for a separate console.

 

 

Health Care Advancements:

  • Concorde devices utilize an extremely low profile configuration enabling a gentle, non-tissue displacing rotational approach technique that eliminates the need to “fire” the needle into breast tissue for positioning.
  • In contrast to the side-cutting stereotactic breast biopsy devices currently available, Concorde device technologies are based on TransMed7’s patented Zero5 technology; in this case consisting of single or twin cutter blades that are forward-cutting and combined forward/side-coring as they move through and part-off (sever) tissues of widely varying densities encountered during breast biopsies. Concorde devices are thus designed to reliably and consistently obtain full-core, uniform-diameter samples with intact architecture from all of these tissue types, without the need for “firing” the device as is common with currently available stereotactic biopsy devices.
  • Concorde devices utilize combined forward/side coring action, meaning that the familiar “round-the-clock-face” repositioning technique is preserved with Concorde, adding no new learning curve hurdles for those currently using older, side coring-only devices.
  • Utilizing TransMed7’s Zero5 technology means that Concorde devices have zero “dead-space” beyond the working tip. Combined with no need for “firing”, these features are designed to provide greater and safer access to lesions located near the skin or other nearby sensitive structures, including radiologic equipment within which breast tissue is constrained.
  • In contrast to currently marketed stereotactic breast biopsy devices, Concorde devices do not require the use of a separate console, eliminating the expense of this additional capital equipment as well as the space required for this equipment in the surgery suite.
  • Concorde breast biopsy devices are designed to be compatible with all stereotactic breast biopsy equipment currently on the market.

Development Status:

The Concorde devices have been developed under a TransMed7 internal Project.  Regulatory documents for market release in the U.S. as well as internationally are being prepared for submission, pending final validation testing.

Technology Details:

The Concorde product platform is described further below.

  • Singel insertion, multiple sample (SIMS) biopsy device (i.e. one-piece coring, parting-off, and vacuum transport mechanism);
  • Specifically modified with additional features adapted to stereotactic and MRI based biopsy procedures.

Concorde