March 10, 2009 – Vidacare is showing its FDA-cleared and CE-marked OnControl Aspiration and Biopsy Systems for bone marrow at the SIR 2009 annual meeting, and said it will be available in the summer of 2009.
The process for accessing bone marrow to perform diagnostic procedures has been largely unchanged over the past 50 years. The OnControl Aspiration and Biopsy Systems combine a lithium-powered driver with a needle set to obtain bone marrow and provide comfort with minimal pain for patient, speed with insertions in seconds, not minutes, and for successful outcomes.
In 2007, a study was undertaken to validate the performance of the first generation OnControl Aspiration System. Forty-three patients were included in the beta testing, which reflected ease-of-use, rapid insertion times, minimal patient pain, no complications, and an overall user assessment of 8.1 (on a scale of 0-10, with 0 being extreme dissatisfaction and 10 being extremely satisfied). This validation study also reported pain on a scale of 0-10 (0=no pain; 10=worst possible pain). The median pain score observed with the OnControl system was 2.0, and mean insertion time was 4.9 seconds vs. 7.3 minutes for manual needle from previously published studies.
The OnControl Aspiration and Biopsy System consists of the OnControl power driver and patented, specially designed needle sets. The aspiration needle set includes a 15 gauge, bi-beveled needle with Luer lock connector and stylet, and is available in three lengths: 25mm, 68mm, and 90mm. Included in a procedural tray with the needle sets are sharps protectors, designed to protect the medical staff from inadvertent needle sticks.
The OnControl Biopsy System will be commercially available summer 2009 and is appropriate for all adult patients requiring bone marrow biopsies. The OnControl Biopsy System addresses the challenges of patients with hard bone cortex, those with osteoporosis or fragile pelvises, and those for whom biopsies have previously been difficult or painful. The OnControl Biopsy System, with a thread welded inside the biopsy cannula, reliably captures bone marrow samples.
For more information: www.vidacare.com