Cardinal Fine-Needle Core Biopsy Device Platform

The Cardinal product platform of soft tissue biopsy devices has been generated to fulfill the needs of clinicians across medical fields for next-generation, minimally invasive, cost-effective devices designed to safely, reliably, and consistently obtain high-quality biopsy samples for initial diagnostic purposes from small tissues of the body and/or from those tissues located in difficult to access areas.

Design Features:

  • TransMed7’s patented Zero5 technology scalable down to 22 gauge or smaller.

 

 

Health Care Advancements:

  • Cardinal devices are manufactured in very small sizes and are designed to obtain biopsy samples from small or fragile tissues of the body (such as lymph nodes, thyroid, liver, and pancreas, for example), similar to a procedure called “fine-needle aspiration” (FNA). However, in contrast to fine-needle aspiration technologies, Cardinal devices are designed to have additional capabilities as “fine-needle core biopsy” devices.  This is possible because Cardinal platform technologies use TransMed7’s patented Zero5 technology with a forward-cutting, forward-coring working element designed to obtain solid, full-core, uniform-diameter tissue samples with intact architecture for histopathology analysis, rather than the more limited cytology studies.
  • As with other devices utilizing TransMed7’s Zero5 technology, there is no “dead space” beyond the tips of the Cardinal beaks, meaning that the working element can obtain core biopsy samples all the way through (and beyond, if desired) the target tissue, thereby minimizing potential damage to important nearby structures (e.g. nerves, blood vessels, neighboring organs). Cardinal devices are thus designed to be as safe as possible while maintaining a high degree of cost-effectiveness and ease of use, allowing clinicians who currently perform fine needle biopsy procedures to readily adapt to using the Cardinal devices.

Development Status:

The Cardinal devices are currently being developed under a TransMed7 internal Project.

Technology Details:

The Cardinal product platform is described further below.

  • Needle-set scaled to 21 gauge to 31 gauge for use as a “fine needle core biopsy” device for breast, thyroid, lymph nodes, other;
  • Shown with adaptation to an external vacuum/handle set, but also may be adjusted to a hypodermic syringe.

Cardinal