- (COMTEX) B: INAMED Health Announces FDA Approval and Launch of the LAP-BAND VG System Next-Generation Product Offers a Safer, Le
- B: INAMED Health Announces FDA Approval and Launch of the LAP-BAND VG System Nex-Generation Product Offers a Safer, Less Invasive Surgical Weight-Loss Option to a Broader Range of Patients
-
- DENVER, Colo., Apr 1, 2004 (BUSINESS WIRE) -- INAMED Health, a division of
- INAMED Corporation, (Nasdaq:IMDC) and the developer of the BioEnterics(R)
- LAP-BAND(R) System, today announced market introduction and U.S. Food and Drug Administration approval of a significant product line extension. The LAP-BAND(R) VG system is designed to meet the needs of a more diversified and broader patient population, including patients with a larger internal anatomy.
-
- Obesity is the second leading preventable cause of death in the United States --
- and it is expected to overtake smoking as the leading cause soon. "The demand
- for INAMED Health's LAP-BAND System continues to grow and is quickly gaining
- recognition as the safest and least invasive weight-loss surgery procedure
- available," said Nick Teti, Chairman, President and CEO of INAMED Corporation.
- "With the introduction of the new LAP-BAND VG, we are now able to serve an even greater patient population."
-
- "There are also significant benefits for the surgical community," added Teti.
- "The LAP-BAND VG system requires less fat dissection, has easier band placement and new technology to decrease the risk of crease-fold failure seen in
- competitor products. We expect this versatile product to be readily adopted by
- the U.S. surgeon."
-
- Approved by the FDA in January 2004, the LAP-BAND VG System will now be widely available in the United States and many international markets.
-
- HOW IT WORKS
-
- The LAP-BAND VG System is an adjustable, inflatable silicone band that is
- laparoscopically placed around the upper portion of the stomach, creating a
- small gastric pouch that limits the amount of food the stomach will hold at any
- time. The band controls the flow of food from this pouch to the rest of the
- digestive tract, leaving the patient feeling comfortably full with only a small
- amount of food, without compromising the absorption of nutrients. Thus, the
- patient will continue to feel full for several hours, thereby reducing the urge
- to eat between meals. The band can be adjusted by a trained physician for
- patient satisfaction and achieving weight-loss objectives.
-
-
- THE LAP-BAND VG SYSTEM ADVANTAGE
-
- -- A wider adjustment range accommodates physically larger
- patients and their weight-loss needs
-
- -- Appropriate for patients with thicker gastric walls or
- substantial internal fat
-
- -- Larger band circumference addresses larger patients (BMI
- greater than or equal to 45)
-
- -- Designed for greater ease in band placement
-
- -- OmniForm(TM) technology maintains softly curved shape
- throughout the adjustment range
-
- The current LAP-BAND System was approved by the U.S. Food and Drug
- Administration in June 2001. Since its international market introduction in
- 1993, the LAP-BAND System has been used in more than 120,000 procedures
- worldwide
-
-
- THE BENEFITS OF THE LAP-BAND SYSTEM
-
- -- Safest surgical option -- up to 10 times greater safety, on
- average, than that of the gastric bypass
-
- -- Least invasive surgical option
-
- -- On average, shorter hospitalization and recovery times
-
- -- No cutting or stapling of the stomach or intestinal re-routing
- necessary
-
- -- Only adjustable surgical option -- can adjust the size of the
- outlet created by the LAP-BAND System for an individualized
- rate of weight loss
-
- -- Only reversible surgical treatment option -- the LAP-BAND
- System can be removed at any time
-
- The LAP-BAND System and the LAP-BAND VG System were developed by INAMEDCorporation, a global healthcare company with over 25 years of experience developing, manufacturing, and marketing innovative, high-quality, science-based products. Current products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products for facial rejuvenation; and minimally invasive devices for obesity intervention, including the LAP-BAND System and the LAP-BAND VG System for the severely obese.
-
- Forward-Looking Statements
-
- This press release contains forward-looking statements, including, without
- limitation, express and implied statements regarding INAMED's LAP-BAND(R) System product platform. INAMED is providing this information as of April 1, 2004 and expressly disclaims any duty to update information contained in this press
- release.
-
- These forward-looking statements involve risks and uncertainties which could
- cause actual results to differ materially from those expressed or implied here.
- Readers are referred to the documents filed by INAMED Corporation with the
- Securities and Exchange Commission, specifically the most recent reports which
- identify important risk factors that could cause actual results to differ from
- those contained in the forward-looking statements, including but not limited to:
- exposure to product liability and intellectual property claims; exposure to
- liabilities that may not be adequately covered by insurance or for which there
- is no insurance; potential negative publicity concerning product safety; changes
- in the economy and consumer spending; competition from existing and/or new
- products; failure or delay of clinical trials; uncertainty in receiving timely
- regulatory approval or market acceptance for new products; dependence on a
- single supplier for INAMED's silicone raw materials; failure to protect INAMED's
- intellectual property; and adverse changes in the regulatory or legislative
- environment (both in the U.S. and internationally) affecting our business. The
- information contained in this press release is a statement of INAMED's present
- intention, belief or expectation and is based upon, among other things, the
- existing regulatory environment, industry conditions, market conditions and
- prices, the economy in general and INAMED's assumptions. INAMED may change its intention, belief or expectation, at any time and without notice, based upon any changes in such factors, in INAMED's assumptions or otherwise. INAMED undertakes no obligation to review or confirm analysts' expectations or estimates or to release publicly any revisions to any forward-looking statements to reflect
- events or circumstances after the date hereof or to reflect the occurrence of
- unanticipated events.
-
- By including any information in this press release, INAMED does not necessarily
- acknowledge that disclosure of such information is required by applicable law or
- that the information is material.
-
- SOURCE: INAMED Corporation
-
-
- CONTACT: Investors: INAMED Corporation
- Charlie Huiner, Director, Corporate Development and
- Investor Relations, 805-692-5425
- or
- Press: Behrman Communications
- Jodi Balkan / Misty Koons, 212-986-7000
-
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