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FDA approves EDAP Technomed's LT.02. lithotripter; Device uses piezoelectric energy for anesthesia-free kidney stone destruction.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 6, 1997--EDAP Technomed, a leading manufacturer of minimally invasive medical equipment, today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) approved the LT.02, the most advanced generation of piezoelectric The property of certain crystals that causes them to produce voltage when a mechanical pressure is applied to them such as sound vibrations. This technique is used to build crystal microphones, phonograph cartridges and strain gauges, all of which turn mechanical movement into voltage.  lithotripters. The term "lithotripsy" refers to the non-surgical method for fragmenting kidney stones through the use of extracorpreal shockwaves.

The LT.02 combines a new powerful piezoelectric treatment head with an in-line, real-time and isocentric dual imaging system: ultrasound and fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope.

fluo·ros·co·py
n.
Examination by means of a fluoroscope. Also called radioscopy.
 for optimal stone localization. The piezoelectric shockwave permits maximum stone fragmentation while minimizing the negative effect on tissues. In addition, LT.02's technology allows for an anesthesia-free, ambulatory lithotripsy procedure, thereby minimizing the risk of complications and side effects.

The LT.02 has been available outside of the U.S. since 1992. Approximately 100,000 patients have been successfully treated worldwide. Today, with more than 450 lithotripters installed, including Sonolith 3000 and 4000+, Pulsolith., and LT.01, EDAP Technomed holds approximately 20% of the world lithotripsy market.

EDAP Technomed is the world leader in the development and marketing of microwave thermotherapy for the treatment of Benign Prostatic Hyperplasia benign prostatic hyperplasia
n. Abbr. BPH
A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine.
 (BPH BPH
abbr.
benign prostatic hyperplasia


BPH
Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men.
) with Prostatron. Prostatron represents a breakthrough in the treatment of BPH, or enlarged prostate. It is the first microwave thermotherapy device to receive FDA approval for the non-surgical treatment of symptomatic BPH. In addition, EDAP Technomed is currently in the process of developing High Intensity Focused Ultrasound HIFU (high intensity focused ultrasound) (sometimes FUS or HIFUS) is a highly precise medical procedure using high-intensity focused ultrasound to heat and destroy pathogenic tissue rapidly.  (HIFU HIFU High-intensity focused ultrasound Surgery A method that focuses ultrasound to heat/ablate target tissue without injuring surrounding structures. See Sonablate 200™. ): a promising new technology for cancer treatment.

EDAP Technomed is an international company engaged in the development, manufacture and distribution of minimally invasive therapeutic devices for the treatment of urological diseases including kidney stone disease, BPH and cancer. EDAP Technomed, Inc. based in Cambridge, MA, is the US distributor of the LT.02.

CONTACT: EDAP Technomed, Inc.

Christine Meehan, 617/441-9212

edaptech@tiac.net

www.edaptechnomed.com
COPYRIGHT 1997 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1997, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jan 6, 1997
Words:302
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