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Vidacare's OnControlâ„¢ Bone Marrow System Is Quantum Leap Forward for Bone Marrow Procedures
March 1, 2010

Much-Anticipated Technology That Offers Alternative to "Barbaric" Traditional Procedures Is Now Commercially Available

(SAN ANTONIO) - For many cancer patients, a bone marrow biopsy and/or aspiration is one of the most dreaded aspects of their diagnosis and treatment plan. The traditional method for gaining bone marrow involves grinding a needle by hand and sheer force through a patient's skin and bone, and the procedure is often described as "brutal," "excruciating" and even "barbaric."

No longer.

The OnControl™ Bone Marrow System by Vidacare Corporation is now available and provides the first significant advance in bone marrow procedures in over 50 years by combining a lithium battery-powered driver with a specially designed, patented needle set to obtain marrow using Vidacare's patented technology platform. OnControl offers clinicians a safe, fast and easy way to perform bone marrow aspiration and biopsy procedures and offers patients a less painful experience.

With nearly 700,000 bone marrow diagnostic procedures done in the U.S. annually, these procedures can be difficult due to the pain involved for the patient and the strenuous nature of getting the bone marrow for the clinician. Traditional bone marrow procedures use a manual device hand-inserted by the clinician and can take from 2 minutes to more than 30 minutes, with a mean of 7 minutes, to collect a core biopsy. The procedure can be arduous for the clinician and very painful for the patient. Frequently, a second or third attempt is required to collect a core of sufficient length. 

The quality of the captured samples is also an issue; in an article published in the Journal of Clinical Pathology (FW Bishop, K McNally, M Harris. Audit of bone marrow trephine biopsy. J Clin Path 1992: 45: 1105-1108), investigators reported that 58% of the time, the samples collected were "inadequate". This can pose serious challenges to clinicians who analyze the samples and to those whose clinical judgment and treatment decisions rest on this analysis.

The OnControl™ Bone Marrow System addresses these issues and offers patients and clinicians a safe, fast, reliable and more comfortable alternative to the traditional manual procedure, and consists of a patented power driver and needle set based on Vidacare's innovative intraosseous technology platform. 

Prior to its full launch, 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 thirteen sites in the U.S. participated in this evaluation, and all were first-time users. Testing sites included the Cancer Research and Technology Center of the University of Texas/San Antonio (San Antonio, Texas), M.D. Anderson Cancer Center (Houston, Texas), Wilshire Oncology (Glendora, CA) and Kaiser Permanente Riverside (Riverside, CA) 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, with 5 indicating high satisfaction)
• 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
• Zero complications.*

"The OnControl Bone Marrow System will increase the efficiency of bone marrow biopsies and aspirations while also reducing patient discomfort," said Phil Faris, President and CEO of Vidacare. "We are very happy to be able to offer clinicians and patients a better way."

"Just lying on the table waiting for the next move is a major anxiety. With your [OnControl] device, it was over quickly, and afterward, I noticed I was not as sore as the ones before," noted a patient on whom the system was used. "The bone marrow aspiration is the WORST part of my treatment - it is worse than being hooked up to an IV for 5 hours. Your system is definitely better."

Established in 2001, Vidacare is the leading developer, manufacturer and marketer of advanced intraosseous technology which offers the potential to establish new standards of clinical excellence in the safe, rapid performance of medical procedures using the intraosseous space. The Wall Street Journal named Vidacare's EZ-IO Vascular Access System its sole Technology Innovation of the Year Gold Award Recipient in October, 2008. Vidacare products are marketed in over 50 countries worldwide. www.vidacare.com

*It should be noted that while adverse events are rare, bruising, bleeding and infections of the insertion site are the most frequently reported incidents with bone marrow procedures.

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