April 26, 2012 — Devicor Medical Products Inc. announced the commercial launch of the Mammotome elite Biopsy System, the only tetherless single insertion, multiple sample, vacuum-assisted biopsy (VAB) device featuring proprietary TruVac vacuum technology. Unlike other 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. In March, Devicor received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to use the system on patients. The product has also received CE marking in Europe.
The Mammotome elite system includes a reusable holster, charging base and 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 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," said Devicor CEO Tom Daulton.
In 2011, more than 1.4 million women in the United States underwent a biopsy procedure with approximately 40 percent of those undergoing vacuum-assisted breast biopsies. VAB procedures are growing in popularity with clinicians and patients because they are less invasive than surgery.