CINCINNATI
/PRNewswire/ — Devicor® Medical Products, Inc. (Devicor), announced today
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 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. 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.
