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Initial Clinical Experience With a Flexible Peripheral 21-G Needle Device.

Alain Tremblay1, Renelle Myers2, Eve-Lea Beaudoin2

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A new flexible nitinol needle for transbronchial needle aspiration (TBNA) shows promise for diagnosing peripheral lung nodules (PLN). This novel device demonstrated safety and effectiveness in initial cases, offering potential advantages for lung nodule sampling.

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Area of Science:

  • Pulmonology
  • Interventional Pulmonology
  • Medical Devices

Background:

  • Bronchoscopic techniques are crucial for sampling peripheral lung nodules (PLN).
  • Transbronchial needle aspiration (TBNA) enhances diagnostic yield for PLNs.
  • Existing needle devices have limitations for peripheral lung sampling.

Purpose of the Study:

  • To evaluate the initial clinical experience with a new flexible nitinol peripheral TBNA needle.
  • To assess the safety and effectiveness of this novel device for sampling PLNs.

Main Methods:

  • Retrospective case review of the first clinical uses of a 21-G peripheral TBNA device.
  • Procedures were performed by 11 operators across 4 centers.

Main Results:

  • 40 procedures were performed on PLNs with a mean size of 35.1 mm, located 18.8 mm from the pleural surface.
  • The needle was rated as good or excellent for reaching PLNs in 90% of cases.
  • The TBNA sample was diagnostic in 45% of cases overall (64.3% when diagnosis was possible), with no reported complications.

Conclusions:

  • The novel peripheral TBNA device appears safe and effective for sampling PLNs.
  • This device may offer technical advantages over existing options.
  • Further studies are needed to confirm its role in bronchoscopic lung nodule sampling.