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Deflux Efficacy/Long-Term Results - Palette Life Sciences

Long-term clinical success of Deflux

Deflux has been shown to be efficacious in clinical studies, although its efficacy varies based on what injection technique is used.


Long-Term Results

Evaluating success 1 year after treatment (1)



54 children ages 7 months to 16.6 years (mean age 4.1 years) underwent Deflux treatment using the Double HIT technique, with an average follow-up of 19 months and a VCUG 1 year after treatment. Radiographic success was defined as a negative VCUG at 1 year; clinical success was defined as no febrile UTIs at 1 year.


In 3 additional clinical studies (1 randomized, 2 non-randomized), the efficacy of Deflux was evaluated. These studies included 189 total patients. The 12-month success rate of these studies ranged from 54% to 69%, using the STING technique. (2)


There are three common techniques used with Deflux injection:


The STING technique is a subureteric injection in which the needle is placed directly below the ureteral orifice at the 6 o’clock position. (3)


The HIT technique is a single intra-ureteric injection technique that is a modification of STING. (3)


The Double HIT technique is a refinement of the STING and HIT procedures and includes both proximal and distal intra-ureteric injections. (3) A 2014 study shows, the Double HIT technique is the most commonly performed technique for correction of VUR by pediatric urologists in the U.S. 4 In that study 92% of Deflux procedures use the Double HIT technique which has demonstrated higher efficacy rates. (4)


REFERENCES:

1. Kalisvaart JF, Scherz HC, Cuda S, Kaye JD, Kirsch AJ. Intermediate to long-term follow-up indicates low risk of recurrence after Double HIT endoscopic treatment for primary vesicoureteral reflux. J Pediatr Urol. 2012;9(4)359-365.

2. Deflux [prescribing information]. Santa Barbara, CA: Palette Life Sciences, Inc.; 2019.

3. Diamond DA, Mattoo TK. Endoscopic treatment of primary vesicoureteral reflux. N Engl J Med. 2012;36:1218-1226.

4. Kirsch AJ, Arlen AM, Lackgren G. Current trends in dextranomer hyaluronic acid copolymer (Deflux) injection technique for endoscopic treatment of vesicoureteral reflux. J Pediatr Urol. 2014; 84: 462-468.

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