Long-term study on biolitec®’s anal fistula therapy FiLaC®

Jena, November 13, 2017 – A long-term study on the treatment of anal fistulas conducted on 117 patients with an average follow-up period of 25.4 months (overall study duration of 6-60 months) confirms a primary success rate of 64.1% from initial therapy using FiLaC®. The secondary cure rate (a second smaller procedure) was as high as 85.5%. Thus, the minimally invasive laser therapy FiLaC® is the modern, sphincter-sparing first-line treatment option for anal fistulas. Laser therapy can also be used for coccygeal fistulas.

In the FiLaC® therapy from the medical technology firm biolitec®, a flexible, radially emitting FiLaC® fiber is placed precisely at the internal orifice using a pilot beam, and the energy is emitted over the course of the fistular track. The efficient irradiation concept of the FiLac® fiber optimally uses the applied energy to close the fistular track. The treatment was performed using either a CERALAS® or a LEONARDO® DUAL 45 diode laser from the biolitec biomedical technology GmbH. This type of laser delivers energy with a wavelength of 1470 nm and an optimal absorption curve in water, which has the result of efficient local tissue shrinkage and protein denaturation. All areas of the surrounding musculature remain maximally preserved. Incontinence is generally avoided.

The study was published on March 7, 2017 by A. Wihelm et. al. It was conducted between October 2009 and July 2014 at the Cologne Rectal and Pelvic Floor Center (EBZ) on a treatment group of 117 patients with an anal fistula who were treated with the FiLaC® method. The objective of the study was the observation and evaluation of the treatment method of laser ablation over a long-term period. The FiLaC® procedure combines the objectives of successful fistula treatment, that is, clinical efficacy plus preservation of continence function.

A selection of the findings from the study:
-No case of incontinence of liquid stool occurred.
-The primary cure rate was 75/117 overall (64.1%); for cryptoglandular anal fistulas, it was 63.5%, and for fistulas secondary to Crohn”s disease, it was 69.2%.
-Of the 42 patients in whom FiLaC® did not work, 31 underwent a further operation (fistulectomy with sphincter muscle reconstruction or fistulectomy).
-The secondary cure rate (healing of the fistula at the end of the study period) was 103/117 overall (85.5%); for cryptoglandular anal fistulas it was 85.5%, and for fistulas secondary to Crohn”s disease, it was 92.3%.
-A significantly higher primary success rate was demonstrated for intersphincteric fistulas, with primary and secondary success-independent of age, sex, Crohn”s disease, number of previous operations, or the type of coverage using a skin flap.

The study was published in: A. Wilhelm / A. Fiebig / M. Krawczak (2017): Five years of experience with the FiLaCTM laser for fistula-in-ano management: long-term follow-up from a single institution; in: Techniques in Coloproctology (2017) 21:269-276.

Specialists can find further information about biolitec®”s innovative laser therapies at www.biolitec.com (http://www.biolitec.com). Patients can find further information at www.info-anal-fistula.com (http://www.info-anal-fistula.com) and www.pilonidal-cysts.com (http://www.pilonidal-cysts.com) or through the infoline at +49 6172 27159 11.

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