New Tetherless Vacuum-Assisted Biopsy System

Devicor Medical Products commercially launched 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, elite provides a vacuum that achieves nearly the same suction power of the traditional 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. elite 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.

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. In March 2012, Devicor received 510(k) clearance for Mammotome elite Biopsy System from the U.S. FDA for use on patients; the product has also received the European CE marking.

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