Devicor Announces CE Mark Approval For Mammotome® revolve™ Biopsy System

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Devicor Announces CE Mark Approval For Mammotome® revolve™ Biopsy System

PR Newswire CINCINNATI, Dec. 18, 2012

- Featuring patented DualVac™ technology and patented specimen management system

CINCINNATI, Dec. 18, 2012 /PRNewswire/ -- Devicor® Medical Products, Inc. (Devicor) announced today that it has completed the necessary steps to place CE Mark on Mammotome® revolve™, its new dual vacuum-assisted biopsy system. The product has also received approval from the United States Food and Drug Administration.

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 that gives clinicians the ability to secure larger contiguous tissue samples.

These features in combination with a doctor-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", said DrTeri-Ann Gizienski of Magee-Womens Hospital of Cranberry. "M ammotome® 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 organised and so easy to manage, even for the specimen radiograph. This is ideal for doctors and facilities that are very busy, but still want great tissue. It's a phenomenal system".

Devicor President and CEO Tom Daulton 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. Daulton said, "Mammotome® revolve(TM) 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 worldw ide leader in the field of vacuum assisted breast biopsy", added Daulton.

VAB procedures are growing in popularity with clinicians because they are less invasive than surgery. Over four million women worldwide have had successful breast biopsies using the Mammotome® Biopsy System since 1995.

Mammotome® revolve™ is currently available in limited market release inEurope, the United States and Canada. Mammotome® revolve™ is expected to be available in full market release by spring 2013.

About Devicor® Medical Products, Inc. Devicor® Medical Products, with its headquarters in Cincinnati, Ohio, USA, has more than 400 employees worldwide. The company is committed to advancing technology to help clinicians accurately diagnose breast disease, such as breast cancer, through minimally invasive procedures. Devicor's product portfolio includes the world-renowned Mammotome® Breast Biopsy System, neo2000® Gamma Detection System (GDS) and tissue markers (MammoMARK™, MicroMARK®II and CorMARK™) use d in breast disease diagnostic sampling and management. These products are sold in more than 50 countries around the world. Since its introduction in 1995, more than four million women have had a minimally invasive breast biopsy in stereotactic, ultrasound or MRI- guidance imaging using the Mammotome® Breast Biopsy System. For more information, please visit www.devicormedical.comorwww.mammotome.com.