1470 nm diode laser gains FDA clearance for vein surgery

March 14, 2008, East Longmeadow, MA--biolitec has received 510K clearance to market its ELVeS PL laser for use in vein surgery. The device is specifically indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The diode laser is the energy source for the ELVeS PL (Endo Laser Vein System) endoluminal laser therapy system, which is used in a non-contact mode that is especially suited to out-patient treatment in the office environment. According to the company, ELVeS PL laser treatment provides swift, safe outpatient procedures that can be performed in the doctor's office. Using a laser tuned to 1470 nm delivered through an optical fiber, ELVeS PL lets doctors quickly achieve photodestruction and collapse of vein walls, treating the entire length to ensure complete closure of the vein. This provides a fast (45 minute) procedure with rapid patient recovery to normal activities.

Many medical laser systems for vein ablation use a 980 nm wavelength, which is absorbed by water to ablate tissue by creating vapor bubbles in nearby fluids. The ELVeS PL system uses a 1470 nm wavelength, which has 40 times greater absorption by water and more specifically targets soft tissue in the vein wall. The pain reported by patients treated with the 1470 nm laser was significantly lower than that reported by those treated with the 980 nm laser. During follow-up exams substantially less ecchymosis was observed after ablation with the 1470 nm laser than with the 980 nm laser and there was more paresthesia after ablation with the 980 nm laser than was seen with the 1470 nm.

The portable ELVeS PL system weighs only 7.5 kg and produces up to 15 W of optical power. The laser unit can operate with 100V-240V power, making it convenient for use in a physician's office without the need for special wiring. The laser can be set for continuous or pulsed energy delivery, with pulse widths ranging from 0.01 to 99.9 seconds.

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