Vidacare Announces Clearance Of Novel Bone Marrow Biopsy System For Hematology/Oncology

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Dec 2007 - 3:00 PDT

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Vidacare, the leading developer, manufacturer and marketer of advanced intraosseous technology, announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its new bone marrow biopsy (trephine) system. With its lithium-powered driver, Vidacare's OnControl™ Bone Marrow Biopsy System represents the first effort in decades to improve the speed, control, core capture rate, and patient comfort of the bone marrow biopsy procedure.

"The FDA's approval of the OnControl Biopsy System is a key milestone for Vidacare as well as patients requiring bone marrow biopsies," says Philip Faris Jr., CEO and president of Vidacare. "Bone marrow biopsies are the most frequently performed intraosseous diagnostic procedure in the U.S. and around the world. Virtually unchanged for decades, the manual procedure causes pain rated as severe to worst possible pain by nearly 20 per cent of patients participating in a recent study. The goal of the OnControl Biopsy System is to provide greater clinician control while increasing the core capture rate, and decreasing the discomfort experienced by patients and clinicians."

Expanding upon its innovative technology combining a battery-powered driver and specialty needles to rapidly and safely access the intraosseous space, Vidacare has developed the OnControl Biopsy System to significantly advance the current state-of-the-art in bone marrow biopsy (trephine) procedures. Necessary for the diagnosis and management of lymphoma, leukemia, myeloma and other hematological disorders, bone marrow biopsy has historically been very painful for patients. The Vidacare system enables the clinician performing the procedure to quickly and precisely enter the intraosseous space, successfully capture a core, with minimal patient discomfort or pain. The Biopsy System follows the recent launch of the OnControl Aspiration System.

The OnControl Biopsy System uses a lithium-powered driver, connected to patented 11 gauge, 102mm or 152mm needles with specialized bi-beveled cutting tips. The system includes a biopsy tray designed to simplify needle set access and usage while maintaining a sterile environment. The cannula features a standard luer-lock connector. Vidacare has created a training package designed to provide a realistic sensation of needle placement.

Vidacare's mission in developing the OnControl Bone Marrow Biopsy System is to make difficult biopsies a thing of the past.

About Vidacare Corporation

Vidacare® is the leading developer, manufacturer, and marketer of advanced intraosseous (IO) access technology for multiple diagnostic, monitoring, and therapeutic applications. The company's initial product line, the EZ-IO® System by Vidacare, serves the emergent care industry as the world's only lithium-battery powered drill and patented needle set for gaining immediate vascular access when conventional IV access is difficult or impossible. Vidacare's OnControl™ suite of hematology/oncology products includes a power driver and specially-designed needle sets for bone marrow aspiration, stem cell harvesting, and biopsy (trephine). The OnControl™ Aspiration System by Vidacare represents the first in this series of products and is commercially available. Headquartered in San Antonio, Texas, Vidacare was founded in 2001 and owns the exclusive rights to innovative IO technologies developed at the University of Texas Health Science Center-San Antonio.

http://www.vidacare.com

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