Wednesday, February 9, 2011

New Bone Marrow Biopsy Technology Delivers Superior Samples

Studies Show New Bone Marrow Biopsy Technology Delivers Superior Samples, Less Pain when Compared to Manual Devices

OnControl Bone Marrow System Debuted in March 2010

[San Antonio, Texas – February 9, 2011] 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 through a patient’s skin and bone, and the procedure is often described as extremely painful.

Vidacare’s OnControl Bone Marrow System is changing that.

Three separate clinical studies evaluating Vidacare Corporation’s OnControl Bone Marrow System, which was introduced commercially in March of 2010, found that the rotary-powered device yields superior samples and decreased patient pain when compared to traditional manual devices. The studies were presented at the 52nd annual American Society of Hematology in Orlando, Florida in December.



The first study, “A New Rotary Powered Device for Bone Marrow Aspiration and Biopsy Yields Superior Specimens with Less Pain: Results of a Randomized Clinical Study” presented by Ronan Swords, MD, was a 50-patient study (25 OnControl and 25 Manual) and showed:

· 124% faster procedure time for OnControl when compared to Manual

· Significantly lower needle insertion pain (2.6 vs 4.1 on a VAS scale of 0-10)

· Significantly larger core biopsy specimen with mean volume for OnControl at 36.8mm compared to 15.3mm for Manual

· Significantly larger core biopsy specimen with mean usable area for OnControl at 25.4mm compared to 11.9mm for Manual.

“The results of this randomized clinical trial suggest use of the Powered bone marrow biopsy device makes a significant difference in patient pain levels during needle insertion.... Moreover, the superior size and overall quality of core specimens delivered by the Powered device provides more material for pathological evaluation of hematopoietic and oncological disorders,” concluded the study’s authors.

The second study, “Comparing Powered Bone Marrow Biopsy Procedures to Manual Bone Marrow Biopsy Procedures Using Healthy Volunteers” presented by Andrew Brenner, MD, was a 48 sample study on healthy volunteers (24 OnControl and 24 Manual) and showed:

· 100% core biopsy sample core capture rate for OnControl compared to 67% for manual

· 83% faster procedure time for OnControl when compared to manual

· Significantly lower overall pain (20.9 vs 33.3 on a VAS scale of 0-100)

· Significantly larger core biopsy specimens with a mean volume for OnControl of 49.12mm compared to 10.76mm for manual.

“Results suggest use of the Powered bone marrow biopsy device makes a significant difference in overall pain. Perhaps more importantly, the superior size and overall quality of core specimens delivered by the Powered device provides more material for pathological evaluation...” concluded the study’s authors.

The third study, “A Multicenter Randomized Clinical Trial Comparing a Powered Bone Marrow Biopsy System and Manual Bone Marrow Biopsy Procedures” presented by James Berenson, MD, was a 102 patient study which demonstrated:

· 109% faster procedure time for OnControl compared to Manual

· Significantly more OnControl patients were pain free 24 hours after the biopsy procedure; 67% compared to 33% for Manual patients

· Significantly larger core biopsy specimens with a mean volume for OnControl of 36.8mm compared to 20.4mm for Manual.

“The use of this device does shorten the procedure time and reduce intermediate term pain – important considerations for the quality of life for patients with hematopoietic and oncological disorders,” noted the author.

Vidacare’s rotary-powered OnControl™ Bone Marrow System provides the first significant advance to bone marrow biopsies and aspirations in more than 50 years, offering patients and clinicians a vastly improved procedure option. The System commercially launched in first quarter of 2010.

Established in 2001, Vidacare Corporation is the developer of a broad technology platform that is defining the field of intraosseous (inside the bone) medicine. Current products include the EZ-IO ® Intraosseous Infusion System, the OnControl™ Bone Marrow System and the OnControl™ Bone Access System, and applications include vascular access, emergency and disaster medicine, oncology and spinal surgery. Privately held, the company is based in San Antonio, Texas, and its products are marketed in over 50 countries worldwide. www.vidacare.com

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