Devicor Medical Products, Inc, announced that it has received 510(k) clearance from the FDA for the Mammotome elite Biopsy System, a tetherless single-insertion, multiple-sample, vacuum-assisted biopsy device featuring proprietary vacuum technology. Devicor also announced the commercial launch of the device. The new system provides a vacuum that achieves nearly the same suction power of the traditional Mammotome vacuum-assisted biopsy 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. The 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. ■