.decimal, Inc. Gains 510k Clearance from the FDA to Market its p.d(TM) Software for Bolus Electron Conformal Therapy in the United States
Published: May 12, 2009
SANFORD, Fla., May 11 /PRNewswire/ -- .decimal, leading manufacturer of patient-specific medical devices, gains 510k clearance to release the software necessary for the delivery of Bolus Electron Conformal Therapy (Bolus ECT(TM)), an advanced form of patient-specific electron therapy. Treating with bolus ECT will be available to users of all three of the major treatment planning systems: CMS XiO(TM), Varian Eclipse(TM) and Philips Pinnacle3(TM).
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510k clearance to market the device makes it possible for cancer treatment centers in the United States to begin ordering, installing and using .decimal's propriety software, p.d, for bolus ECT. "We are now actively marketing bolus electron conformal therapy, and the response from institutions across the United States has been overwhelming as they begin to see the value to their patients through this innovative technology," says Mark Mills, Senior Vice President of Sales and Marketing at .decimal.
.decimal is the sole manufacturer of the bolus, as well as the sole software provider for bolus ECT planning.
Richard Sweat, President and CEO of the company explains, "The commercial availability of bolus electron conformal therapy is another example of our commitment to providing our customers with innovative treatment solutions and their patients with the best individualized electron treatment available in the world."
Bolus ECT can create favorable dose distributions for certain tumors of the chest wall, breast or head and neck, when a tumor volume has spread out near the patient surface and rendered other treatment problematic for a variety of reasons. Bolus ECT was first used at the University of Texas M.D. Anderson Cancer Center over ten years ago, but did not become commercially available until this software release.
"With this product we are enabling the 80% of radiation oncology facilities in the United States treating with electrons the opportunity to enhance their current electron delivery capabilities through our unique pay-as-you-go, Internet-based manufacturing business model," says Sweat.
.decimal is a medical device manufacturer of patient-specific devices, including missing tissue compensators, modulators for advanced IMRT delivery, bolus compensators for bolus electron conformal therapy, as well as apertures and range compensators used in proton therapy. The company has been providing radiation therapy products for over twenty years. For more information concerning .decimal, please see its Web site at www.dotdecimal.com.
CONTACT: Andrea Andrus, .decimal, 800-255-1613
Web site: http://www.dotdecimal.com/