American Medical Systems Holdings, Inc. (NASDAQ:AMMD) announced
today that it has received FDA clearance and CE mark for the
MiniArc(TM) Single Incision Sling System, a new, less invasive
treatment for female stress urinary incontinence. AMS has already
begun enrolling patients in a clinical evaluation to better understand
safety, efficacy and physician training needs. MiniArc is the latest
addition to the AMS family of sling products, which includes the
market-leading Monarc(R) Transobturator Subfascial Hammock, the
SPARC(R) Suprapubic Sling System and the innovative BioArc(R) hybrid
slings.
The MiniArc sling system involves a simple, single incision
procedure designed to reduce operative invasiveness and enhance
patient recovery. MiniArc incorporates the proven mesh used in other
AMS slings with a simple-to-use delivery system for easy mesh
placement without additional skin incisions required with most other
sling procedures. It is designed for use in the operating room;
however, its low profile design and simple procedure may also make it
appropriate for in-office use. AMS intends to study an office based
application for the MiniArc.
MiniArc is currently being evaluated in a limited number of global
sites to provide physicians the opportunity to assess the
effectiveness and ease-of-use of this innovative device prior to broad
distribution. Martin J. Emerson, President and CEO of AMS, commented,
"We are very excited about the potential of the MiniArc sling;
however, we intend to meet our commitment to physicians and patients
to provide clinical information supporting its use before we make the
product widely available. This approach worked well for us with
Apogee(R) and Perigee(R), and we will follow a similar path to market
with MiniArc as well. We look forward to completing our evaluation and
introducing MiniArc globally later this year."
Professor Dirk J.M.K. De Ridder, MD, PhD, of University Hospitals
KU Leuven, Belgium, the first surgeon to implant MiniArc, said, "I am
pleased with the outcome of the initial implants. MiniArc has a simple
design and is easy to use. The fixation system provides strong holding
force, allowing for effective tissue integration and healing into the
mesh. I like the fact that AMS chose to use the same proven mesh that
has been so successful in their other products."
Ross A. Longhini, Executive Vice President and Chief Operating
Officer of AMS, added, "AMS is committed to continuing our leadership
position in this market by providing physicians with a less-invasive
technology to treat female stress urinary incontinence. The breadth of
our product line signifies our commitment to meeting the changing
trends in this environment. We are excited about the strength of our
product pipeline and continuing to work with physicians on next
generation technologies."
About American Medical Systems
American Medical Systems, headquartered in Minnetonka, Minnesota,
is a diversified supplier of medical devices and procedures to cure
erectile dysfunction, benign prostatic hyperplasia, incontinence,
menorrhagia, prolapse and other pelvic disorders in men and women.
These disorders can significantly diminish one's quality of life and
profoundly affect social relationships. In recent years, the number of
people seeking treatment has increased markedly as a result of longer
lives, higher quality-of-life expectations and greater awareness of
new treatment alternatives. American Medical Systems' products reduce
or eliminate the incapacitating effects of these diseases, often
through minimally invasive therapies. The Company's products were used
to provide approximately 240,000 patient cures in 2006.
More information about the Company and its products can be found
at its website www.AmericanMedicalSystems.com and in the Company's
Annual Report on Form 10-K for 2006 and its other SEC filings.
