FDA Clearance for biolitec's ELVeS Vein Treatment
by Anonymous

EAST LONGMEADOW, MA; June 13, 2002 – biolitec, Inc. announced today that its new ELVeS procedure for the treatment of superficial reflux of the greater saphenous vein has received clearance from the Food and Drug Administration (FDA). (ELVeS: Endo Laser Vein System; pronounced, “Elvis”.)

More than half of Americans over the age of 65 suffer from venous disease, the most common form being varicose veins. “More than 80 million people in the United States alone suffer from varicose veins. Our ELVeS laser procedure provides people with freedom from serious leg pain and confidence in their appearance,” said Dr. Wolfgang Neuberger, biolitec’s Chief Executive Officer.

biolitec’s new minimally invasive laser procedure will offer an effective alternative to the treatment’s predecessor, the surgical stripping of veins – a major surgery that requires general anesthesia, hospitalization, and a prolonged recovery time. In contrast, the biolitec ELVeS treatment tremendously benefits patients because it is performed in only 45 minutes, leaves no scars, and requires only minimal recovery time.

“The ELVeS procedure is less expensive than surgical alternatives. It takes less than an hour to complete, can be performed in a physician’s office – and when finished, patients walk away, returning to daily life as usual,” said Kelly Moran, biolitec’s Chief Operating Officer. “ELVeS is a life-changing procedure. For many it will restore their ability to walk and perform routine physical activities without pain or discomfort. Others will regain pride in their legs’ appearance and feel free to wear shorts or go to the beach again.”

In addition, Lowell Kabnick, MD, vascular surgeon and Director of the Vein Institute of New Jersey said, “early results with ELVeS produced a 98-plus percent efficacy rate with all patients reporting a high rate of satisfaction.”

The ELVeS treatment is relatively simple to perform: First, the greater saphenous vein is located with ultrasound and local anesthesia is administered to the treatment site. A tiny incision is then made behind the knee where a small catheter is inserted into the saphenous vein. Next, a thin, flexible fiber from biolitec’s diode laser is introduced into the saphenous vein. Laser light is then emitted, sealing the vein and eliminating the cause of the varicosities. For one week following the procedure, the patient is to wear compression stockings during the daytime.

“biolitec was an early pioneer in the laser-based vascular procedures market,” said Moran. “Using our Ceralas diode laser laser, Antonio Del Giglio, MD of Verona, Italy, has been performing this varicose vein laser procedure with great success since 1998.”

biolitec’s new treatment is advantageous for practitioners as well as patients. Dr. Kabnick emphasizes the benefits of biolitec’s vertical integration, in terms of the cost-effectiveness of the Ceralas diode laser and its optical fibers. “It’s more of a package deal, which makes it that much more economical, and with better quality control.”

About biolitec, Inc.

Established in 1987, biolitec, Inc. manufactures advanced lasers and fiber optic delivery systems for medical and dental applications. Its strength as a vertically integrated manufacturer enables the production of top quality lasers, fibers, handpieces, and accessories – as well as ongoing research into new medical breakthroughs such as photodynamic therapy (PDT).

For more information, please call biolitec at (800) 934-2377 or visit their website at www.biolitec-us/specialties.com.

biolitec, Inc.
515 Shaker Rd.
East Longmeadow, MA 01028




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