FDA clears MASEP Infini's gamma ray neurosurgery system

MASEP Infini, an innovator in global medical technology, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) of its new Infini™ gamma ray neurosurgery system with patented Independent Beam Switch Control with Programmable Arcs, automated collimator exchange and three-dimensional patient positioning, and MASEP Infini's proven Rotary Focusing technology.  Independent Beam Switch Control with Programmable Arcs allows for fine-tuning of dose distributions to address even the most challenging cases.  Automated collimator exchange and three-dimensional patient positioning allow radiosurgery to be conducted without the need to interrupt procedures to manually exchange collimators or re-position patients.  Since treatment can be initiated by the simple push of a button, procedure times are reduced and patient throughput may be increased versus semi-automated systems.

In today's cost-conscious environment, the patented Rotary Focusing technology that has been incorporated into Infini™ provides customers with reduced system acquisition and maintenance costs.  Rotary Focusing allows Infini™ to operate with fewer cobalt sources than comparable fixed cobalt source systems without compromising total activity levels.

"The Infini™ is a welcome addition to the field of gamma ray radiosurgery," stated Dr. Edward Laws, Director of the Pituitary and Neuroendocrine Center at Brigham and Women's Hospital in Boston. "For patients with indications for gamma ray radiosurgery and for hospitals and clinics who provide it, there was really only one option available and not all healthcare systems could meet the acquisition and replacement costs of this type of equipment. MASEP Infini's new system meets the technological requirements neurosurgeons demand but in an affordable, practical package."

"We are pleased to offer the Infini™ gamma ray stereotactic system to healthcare systems and their patients who require this mode of treatment," stated Bruce Meredith, Vice President, MASEP Infini. "Considerable effort has been put into designing the Infini™ for manufacturability.  This has allowed us to lower our manufacturing costs without compromising quality so that we can pass the cost savings on to our customers.   In addition, the Infini™ systems are inherently less expensive to maintain which lowers customer lifecycle costs.  However, what makes the Infini™ really exciting is the fact that it represents the state-of-the-art in gamma ray neurosurgery technology with its automation and unmatched dose-sculpturing abilities.  The Infini™ represents the future of healthcare – high technology at a lower cost."

Stereotactic gamma ray neurosurgery focuses radiation on specific areas of the brain to treat tumors and lesions. The head is held stationary using special headgear. The patient is then positioned and re-positioned inside the system during the treatment, which is painless and silent.  The surgery does not require an incision, and is typically an outpatient procedure.

About 190,000 Americans are diagnosed with a brain tumor every year.  At least 10% of people with cancer will experience a metastatic brain tumor. With over 100 different types of brain tumors, finding effective treatment requires judicious care and expertly trained specialists. Brain tumors represent a significant burden to the healthcare system and can devastate the lives of patients and their families. Gamma ray radiosurgery is a safe, effective and non-surgical approach that can treat certain types of brain tumors.