The Mammotome® elite Biopsy System will be used to aid in the detection and treatment of breast cancer in ultrasound-guided breast and axillary lymph node biopsies. In March, Devicor received 510(k) clearance from the U.S. Food and Drug Administration for use on patients. The product has also received the European CE marking.
The Mammotome® elite system includes a reusable holster, a charging base and a single-patient-use disposable 13-gauge probe with a bladed insertion tip. This tip is designed to move easily through tissue while allowing physicians to maintain control of the needle even in problematic dense breast tissue. The new lightweight ergonomic design of elite provides superior control for precise needle placement and easy insertion.
Says William R. Poller, M.D., FACR, Director of Breast Imaging at West Penn Allegheny Health System in Pittsburgh, PA, "What makes the Mammotome® elite device unique is its ability to provide the tissue quality of a full VAB device, with the convenience of a disposable core needle. The simplicity of elite's design allows me to maintain my focus on the biopsy site and the single insertion device reduces procedure time, easing patient anxiety. This is a game-changing diagnostic tool."
Tom Daulton, CEO of Devicor, says, "In the last several years, Devicor has invested heavily in developing innovative new tools that help doctors more effectively diagnose and treat breast cancer. Mammotome® elite is the first of many exciting product innovations including markers, next generation VAB and other breast biopsy products we will be bringing to patients and clinicians around the world."
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 and patients because they are less invasive than surgery.
About Devicor® Medical Products, Inc.
Devicor Medical Products, headquartered in Cincinnati, Ohio, has more than 400 employees around the globe. 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™) used 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 4 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.com or www.mammotome.com.