System Offers an Easier Way to Perform Bone Marrow Procedures

The system is designed for all patients requiring bone marrow aspiration, and addresses the challenges of patients with hard bone cortex, those with osteoporosis or fragile pelvises, and those for whom aspirations have previously been difficult or painful. The system also addresses the needs of patients and clinicians when a bone marrow biopsy trephine is required. The complementary OnControl Biopsy System, used for core capture, was developed with the goals of improving patient and clinician comfort, ease of use, and reliability.

A validation study to measure successful sample acquisition rates, quality of sample, ease of use, and overall user satisfaction of the biopsy system involved 31 clinicians in 13 sites in the United States, who were all first-time users. Of the 84 patient procedures completed during the validation testing, the results showed that the mean user satisfaction score was 4.4 (on a scale of 0-5); needle insertion success rate was a high 94%; biopsy core acquisition success rate was 90%; the mean length of the core sample was 1.32 centimeters; and the median time to core extraction was only 81 seconds. Additional early data from aspiration needle insertions using the OnControl System reflected a median pain score of 2 (on a scale of 0-10), with only 7% of patients scoring pain at a level above 6. The OnControl Aspiration System and the OnControl Biopsy System are products of Vidacare (Shavano Park, TX, USA), and have been approved by the U.S. food and Drug Administration (FDA).

Bone marrow examination via aspiration is used in the diagnosis of a number of conditions, including leukemia, multiple myeloma, anemia, and pancytopenia. The bone marrow also produces the cellular elements of the blood, including platelets, red blood cells (RBCs) and white blood cells. While much information can be gleaned by testing the blood itself, it is sometimes necessary to examine the source of the blood cells in the bone marrow to obtain more information on hematopoiesis through bone marrow aspiration and biopsy. An estimated 3.9 million bone marrow diagnostic procedures are conducted globally every year.

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