FDA Approves Dual Vacuum-Assisted Biopsy System

Officials at Devicorn Medical Products Inc. announce that the U.S. Food and Drug Administration (FDA) has approved Mammotome revolve, a dual vacuum-assisted biopsy system, for use on patients.

Mammotome revolve is the next generation biopsy system, leveraging the clinician and pathologist valued benefits of the original Mammotome system to provide high quality tissue specimens, now enhanced in the new system with innovative features to provide further procedural efficiency and ease of use. Mammotome revolve features an advanced specimen management system capable of collecting and organizing high quality individual tissue samples in numbered, specimen radiograph, and pathology-ready chambers that preserve tissue integrity. The system also features patented DualVac vacuum technology, giving clinicians the ability to secure larger contiguous tissue samples.

These features in combination with a physician controlled variable aperture allow clinicians to confirm or adjust sample acquisition in response to procedural situations to confidently access and acquire challenging lesions. An additional benefit is the efficiency of pre-biopsy planning time.

"Mammotome has always given great quality samples that's the most important thing," says Dr. Teri-Ann Gizienski of Magee-Womens Hospital of Cranberry. "Mammotome revolve takes efficiency to a whole new level while giving beautiful samples. It's able to easily sample dense breast tissue, and the speed is remarkable. I was able to capture three great tissue samples from the same location, which was nearly impossible before. The collection system keeps the samples organized and so easy to manage, even for the specimen radiograph. This is ideal for physicians and facilities who are very busy, but who still want great tissue. It's a phenomenal system."

Tom Daulton, Devicor president and CEO, says he believes that larger core samples and reduced procedural time mean a faster and less traumatic experience for the patient, and samples coming back from pathology are likely to have a more definitive diagnosis. Says Daulton, "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."

"The success of our recent new product innovations demonstrates why Mammotome is the undisputed worldwide leader in the field of vacuum assisted breast biopsy," says Daulton.

In 2011, more than 1.4 million women in the United States underwent a biopsy procedure with approximately 40% of those undergoing vacuum-assisted breast biopsies. VAB procedures are growing in popularity with clinicians because they are less invasive than surgery. More than four million women worldwide have had successful breast biopsies using the Mammotome Biopsy System since 1995.