Tetherless Vacuum-Assisted Biopsy System Captures Large, High-Quality Samples

A new biopsy system has been developed to be used to aid in the detection and treatment of breast cancer in ultrasound-guided breast and axillary lymph node biopsies.

Devicor Medical Products, Inc. (Cincinnati, OH, USA), is commercially launching the Mammotome elite biopsy system, the only tetherless single insertion, multiple sample, vacuum-assisted biopsy (VAB) device featuring proprietary TruVac vacuum technology. Unlike competing devices that rely on automated syringes, the system provides a vacuum that achieves almost the same suction power of the conventional Mammotome VAB system, enabling the device to capture large, high quality tissue samples.

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 2012, Devicor received 510(k) clearance from the US Food and Drug Administration (FDA) 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.

William R. Poller, MD, FACR, director of breast imaging at West Penn Allegheny Health System (Pittsburgh, PA, USA), said, “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, said, “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 becoming more popular with clinicians and patients because they are less invasive than surgery.

Devicor Medical Products’ product range includes the world-renowned Mammotome breast biopsy system, neo2000 gamma detection system (GDS), and tissue markers (MammoMARK, MicroMARKII, and CorMARK) used in breast disease diagnostic sampling and management.

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