Devicor, a medical device manufacturer based in Cincinnati, Ohio, received approval from the United States Food and Drug Administration (FDA) for its Mammotome system. The Mammotome system is a breast biopsy device designed to provide undamaged breast tissue specimens. The system also reduces pre-biopsy planning times through efficiency improvements.
According to a press release by the company, the Mammotome device comprises specimen management tools for the collection and organization of individual tissue samples. In addition, the device includes pathology-ready and specimen radiograph champers designed to preserve tissue integrity. With DualVac vacuum technology, physicians also have the ability to collect larger contiguous tissue samples.
Tom Daulton is CEO and president at Devicor. In prepared remarks, he said, "Mammotome revolve uses breakthrough technology that offers peace of mind for clinicians and the patients they treat. With this new product, clinicians can be confident that patients are more likely to have a less painful and traumatic experience.” He continued, "The success of our recent new product innovations demonstrates why Mammotome is the undisputed worldwide leader in the field of vacuum assisted breast biopsy."
According to information from the press release, an estimated 1.4 million women in the United States underwent biopsy procedures in 2011 alone. Of these procedures, approximately 40 percent were vacuum-assisted breast biopsies. Four million women have undergone breast biopsies with the Mammotome system over the past 17 years.