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Vidacare Corporation Gains Expanded FDA Approval on Bone-Access System


10/3/2012 8:46:35 AM

SAN ANTONIO, Oct 02, 2012 (BUSINESS WIRE) -- On the heels of a recent expanded FDA indication to allow for "bone biopsy of the vertebral body and bone lesions," Vidacare Corporation's OnControl(R) Bone Access System has developed a new extension of its technology platform. The OnControl Bone Access System Coaxial Biopsy Tray for powered bone biopsy provides a tool for clinicians to access hard bones and perform biopsies of bone lesions using the company's innovative power-driver and specially engineered needle.

Vidacare's OnControl System received an expanded indication from the FDA in early 2012, allowing for its use in the biopsy of vertebral bodies and bone lesions, moving the System's applicability into a number of relevant clinical settings for interventional radiology. The System was previously indicated by the FDA for use in spinal procedures such as vertebroplasty and vertebral body biopsy.

Vidacare's new OnControl Bone Access System Coaxial Biopsy Tray combines a power driver with a specially engineered sawtooth cannula that allows for fast access to hard and/or difficult to reach bones both easily and efficiently. Clinicians can use the Coaxial Biopsy Tray to access bone lesions and perform multiple biopsies from a single penetration of the cortex with precision and speed, enhancing both the clinician's experience and the patient's comfort.

Vidacare's President and Chief Executive Officer, Mark Mellin, commented, "With the OnControl System, clinicians will get access to bone lesions quickly and extract exceptional biopsy samples efficiently. This new coaxial tray is a standard-setting technological advance that improves both patient care and the clinician experience."

Vidacare's power-driven OnControl(R) Bone System provides the first significant advance to bone biopsies and aspirations in more than 40 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 pioneer of a broad technology platform for accessing the intraosseous (inside the bone) space. Current products include the EZ-IO(R) Intraosseous Infusion System, the OnControl(R) Bone Marrow System and the OnControl(R) Bone Access System. Applications include vascular access, emergency and disaster medicine, oncology and spinal surgery. Vidacare's focus on enhancing clinical efficacy, patient safety and comfort, and reducing complications and their associated costs, has resulted in its devices becoming the recognized technology standard. Privately held, the company is based in San Antonio, Texas, and its products are marketed in over 50 countries worldwide. www.vidacare.com

SOURCE: Vidacare Corporation


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