First Stereotactic Radiation Therapy System Designed to Treat Early Stage Breast Cancer Receives FDA Clearance
Friday, December 29, 2017
The GammaPod System Invented by Scientists at the University of Maryland School of Medicine
The GammaPod ™ – a first-of-its kind stereotactic radiotherapy system to treat early stage breast cancer – has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), paving the way for the manufacturer to bring the system to market for the treatment of breast cancer patients.
“We believe this novel radiotherapy system has the potential to change the paradigm for treating early stage tumors, negating the need for surgery for some patients,” says GammaPod co-inventor William F. Regine, MD, FACR, FACRO, the Isadore & Fannie Schneider Foxman Endowed Chair and professor of radiation oncology at the University of Maryland School of Medicine (UMSOM) and chief of radiation oncology at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC).
“With this breast-specific treatment system, we will be able to deliver high-dose radiation to a tumor while minimizing damage to normal breast tissue and even more importantly, to major organs such as the heart and lungs,” Dr. Regine says.
With advances in imaging and better screening, most breast cancers are diagnosed at an early stage, when the tumor is confined to the breast or nearby lymph nodes but has not spread to distant parts of the body. Patients typically have breast-conserving surgery to remove the tumor (and any lymph nodes where cancer is detected), followed by three to six weeks of radiation.
Invented by scientists at UMSOM, the GammaPod system has been under development for nearly a decade. The prototype was installed and tested at the University of Maryland Medical Center (UMMC).
Cedric X. Yu, DSc, a clinical professor of radiation oncology at UMSOM and chief executive officer of Xcision Medical Systems, LLC, which he founded in 2006. “We envision that one day we’ll be able to neutralize a tumor with a high dose of focused radiation instead of removing it with a scalpel. This approach would spare patients the negative side effects of surgery and prolonged radiation treatments, significantly improving their quality of life.”
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