Coralville, Iowa, (April 11 , 2019) –CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions, along with POLL Medical, are excited to announce U.S. Food and Drug Administration (FDA) 510(k) clearance to market GrayDuck Stents™.
GrayDuck Stents provide custom oral positioning with repeatable tongue deviation during radiotherapy. This innovative solution improves patient treatment and outcomes by sparing the tongue, taste buds and salivary glands from unnecessary dose. The stent can position the tongue in one of several positions; laterally (left or right), depressing (downward) or a combination thereof.
“The GrayDuck Stents 510(k) clearance is exciting and significant in fulfilling our mission of improving outcomes for patients worldwide,” said John Steffen, Director of Product Management at CIVCO Radiotherapy. “The ability to offer a custom device that can be formed in less than 15 minutes is very meaningful for the patient and clinical workflow, while still providing high quality positioning necessary for treatment.”
“510(k) clearance allows GrayDuck Stents to be used on more patients undergoing radiotherapy for head and neck cancer, fulfilling the need for a safer treatment experience by sparing the tongue from unnecessary damage. No other device on the market offers combined multi-directional positioning of the tongue away from the radiation field,” stated Adrian Polliack, CEO of POLL Medical.
GrayDuck Stents are available in Europe with CE Mark, and now available in the U.S with FDA 510(k) clearance. The stents were also issued US Patent #9,504,537 with additional patents pending worldwide.
About CIVCO Radiotherapy
CIVCO Radiotherapy has over 35 years’ experience developing, manufacturing and providing high-quality, innovative, patient-centric solutions in radiotherapy. These solutions include: advanced patient immobilization and positioning hardware and consumables, fiducial markers, couchtops and overlays, software, patient care products and advanced 6DOF robotic patient positioning. Corporate information is available at www.CivcoRT.com.
For further information, please contact:
Shelli Locklear, Sr. Marketing Manager, at +1 319.248.6619 or Shelli.Locklear@CivcoRT.com
COPYRIGHT © 2019. CIVCO RADIOTHERAPY IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. CIVCO RADIOTHERAPY AND CIVCO RT ARE TRADEMARKS OF MEDTEC LLC. ALL OTHER TRADEMARKS ARE PROPERTY OF THEIR RESPECTIVE OWNERS. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. 2019C1477 Rev. A