For years, clinicians have been using sheer force to drill needles into bones for biopsies or aspirations of marrow. The procedure is grueling for patients, to the point of seeming medieval. Many doctors suffer wrist sprains or even carpal tunnel syndrome. A Texas-based company took the advice of several physicians who told them they stood at hardware stores gazing at drills, wondering why there wasn't a powered device on the market.

The OnControl Bone Marrow System by Vidacare (San Antonio) is now being rolled out to provide an advance in bone marrow procedures, possibly the first in more than 50 years, by combining a lithium battery-powered driver with a specially designed, patented needle set to obtain marrow.

“With a manual needle, we know from discussions with clinicians, that it can take up to 30 minutes to do a bone marrow biopsy. With OnControl, in validation studies, it was 81 seconds,“ Becky Ariana, VP and leader of Vidacare's OnControl business unit, told Medical Device Daily.

The traditional approach typically involves manually inserting a needle into the hip bone.

“There are a couple of inherent problems with this,“ she said. “If a patient has hard bones, it can be grueling for the clinician. For the patients it can be a very painful experience. Most people with a hematologic malignancy have told us that when they consider the whole course of their cancer therapy, the bone marrow aspiration is the most dreaded.“

Additionally, Ariana said, clinical data indicate that half of the time, the bone marrow samples pulled manually are inadequate, meaning another procedure must follow for another try.

If it's such a painful procedure, why no anesthesia? Because sedation carries added risks and costs, she said.

Vidacare chose to develop the OnControl system because, “It was an area to attack based on other intraosseous applications,“ Phil Faris, Vidacare president/CEO told MDD. “We had a lot of accumulated experience on how to power a needle into the bone and create a reproducible outcome. This is an extension of our technology platform perfected for vascular access.“

The OnControl was FDA cleared and CE-marked in 2007, but is just now being commercially released (MDD, Dec. 10, 2007). Vidacare waited for validation studies before launching the device.

Vidacare implemented a validation study to measure successful sample acquisition rates, quality of sample, ease of use and overall user satisfaction. Thirty-one clinicians from 13 sites in the U.S. participated in this evaluation, and all were first-time users. Testing sites included the Cancer Research and Technology Centerof the University of Texas/San Antonio (San Antonio), M.D. Anderson Cancer Center (Houston), Wilshire Oncology (Glendora, California) and Kaiser Permanente Riverside (Riverside, California) among others. Of the 84 patient procedures completed during the validation testing, results show:

• Mean user satisfaction score of 4.4 (on a scale of 0-5)

• Needle insertion success rate of 94%

• Biopsy core acquisition success rate of 90%

• Mean length of core sample of 1.32 cm

• Median time to core extraction of 81 seconds

• No complications

The OnControl looks, not surprisingly, like a power drill. It has a thread welded inside the biopsy cannula to capture bone marrow samples quickly. When the procedure is done manually, a doctor must jerk the needle back and forth to break off a core sample. That doesn't happen with the OnControl, resulting in less pain.

Ariana said another study has just accrued 102 patients, half had the traditional procedure and the other half had a biopsy via OnControl. Data has yet to be analyzed. But anecdotally, Ariana said a patient told her, “It's like night and day. It's like the difference between being hit by my four-year-old grandson and Mike Tyson.“

Vidacare is selling use of the device at $125 per procedure. The company supplies the reusable driver and all disposable items. More than 90% ordered so far have taken advantage of this agreement rather than buying the OnControl as a standalone.

“Healthcare providers are under pressure when it comes to capital equipment budgets,“ Faris said. “We're trying to facilitate adoption this way.“

Both Ariana and Faris said Vidacare offers a robust education program and onsite guidance for clinicians.

OnControl is reimbursed by Medicare and private insurers at a level that's higher than the cost of use, another encouragement for adoption, Faris said.

Lynn Yoffee, 770-361-4789;
lynn.yoffee@ahcmedia.com