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Qfix™ Receives 510(k) Clearance for Encompass™ SRS Immobilization System
Avondale, PA, Dec. 4, 2014 -- Today, Qfix (www.Qfix.com), a world leader in radiotherapy patient positioning devices, announced the Encompass™ SRS Immobilization System has received 510(k) clearance from the US FDA for stereotactic radiosurgery (SRS). The Encompass has been used for intracranial radiotherapy treatments for nearly a year and is now cleared to achieve sub-millimeter immobilization to precisely treat multiple lesions with a single isocenter. “We are delighted to receive FDA clearance,” says Dan Coppens, CEO and Chief Technology Officer. “The potential clinical benefits for patients are significant.”
The Encompass SRS Immobilization System utilizes a posterior thermoplastic and anterior open view mask compatible with optical tracking systems. Combined with the Encompass™ SRS Fibreplast™ System, the Encompass allows for high-precision, sub-millimeter accuracy and immobilization for stereotactic radiosurgery. In addition, the optional IntegraBite™ can be used to further reduce motion, allowing for maximum dose to the tumor while minimizing radiation delivered to the surrounding healthy tissue. The innovative Integrated Shim System™ of the Encompass SRS Fibreplast System provides a 4 mm range of height adjustment utilizing discrete 0.5 mm increments to optimize immobilization. The Encompass SRS Immobilization System is designed to optimize workflow efficiencies, increase patient throughput and improve patient outcomes. It is available as a kVue™ Insert, for use in simulation on kVue™ CT and treatment on kVue™ Couch Top, a standalone device for use with non-kVue CT simulation and treatment surfaces and is now available in an MRI compatible standalone device for MR imaging and treatment (patents pending).
Qfix is a world leader in radiotherapy dedicated to helping medical professionals provide the best patient care with the world's finest positioning devices to enhance the probability of positive patient outcomes. For more information, visit www.Qfix.com.
Lisa Vandenberg, 610-268-0585