Cincinnati, Ohio-based Devicor landed FDA approval for its Mammotome revolve biopsy system, a next-generation biopsy system designed to provide high quality tissue specimens while improving the efficiency of pre-biopsy planning time.
The Mammotome system features specimen management for collecting and organizing high quality individual tissue samples in numbered, as well as specimen radiograph and pathology-ready chambers to preserve tissue integrity. The less invasive DualVac vacuum technology also helps clinicians secure larger contiguous tissue samples, according to the press release.
"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," president & CEO Tom Daulton said in prepared remarks. "The success of our recent new product innovations demonstrates why Mammotome is the undisputed worldwide leader in the field of vacuum assisted breast biopsy."
The company said that more than 1.4 million women in the U.S. experienced a biopsy procedure in 2011 and 40% of them underwent vacuum-assisted breast biopsies, according to the press release.
Over 4 million women worldwide have had successful breast biopsies with Mammotome biopsy system since 1995, the company said.
The Mammotome revolve device is available via a limited market release in the U.S., Canada and Europe. The company expects to receive full market clearance by next spring.