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Benefits of Solesta - Palette Life Sciences

The quick and simple nonsurgical option for fecal incontinence (1)


SOLESTA IS THE ONLY INJECTABLE GEL TO BE ADMINISTERED IN AN OUTPATIENT SETTING WITHOUT THE NEED FOR ANESTHESIA. (1)


Solesta is a biocompatible tissue bulking agent injected into the submucosal layer of the anal canal.


It is an easily injectable, viscous gel made from two polysaccharides, Non-Animal Stabilized Hyaluronic Acid (NASHA) and Dextranomer (Dx) microspheres. (1) The Solesta implant is stable, remains in position, and does not disappear over time. (2)


Solesta must not be injected intravascularly as injection into blood vessels may cause vascular occlusion. Injection in the midline of the anterior wall of the rectum should be avoided in men with an enlarged prostate.


Studies have shown that Solesta can help patients return to a more active lifestyle (socializing, going to work, etc.) and reduce overall depression and embarrassment associated with their bowel control problems. (3)

SOLESTA CONTAINS NASHA, A TRUSTED AGENT WITH OVER 20 YEARS OF CLINICAL EXPERIENCE (1,2)

  • More than 200,000 children worldwide with vesicoureteral reflux have been treated with the same compound that is contained in Solesta (2)

  • Low risk of hypersensitivity reactions (1%) (2)

  • The material does not migrate from the injection site (2)



SOLESTA EFFICACY HIGHLIGHTS (1)

  • Significant reduction in fecal incontinence episodes

  • Durable efficacy shown up to 36 months

  • Measured impact on quality of life

  • Dependable results without surgery

  • 96% of adverse events were mild to moderate

  • Patients receiving Solesta experienced a 3x greater improvement in FIQOL Lifestyle score vs sham


SOLESTA CLINICAL STUDIES1

Clinical data supporting the safety and effectiveness of Solesta are available from three clinical studies: 

  • a pivotal, prospective, multicenter, randomized, sham-controlled double-blind study of 206 patients conducted under an Investigational Device Exemption (IDE; Pivotal study),

  • a prospective, multicenter, open-label study of 115 patients conducted outside the United States (Open-Label study), and

  • a single center study of 34 patients conducted at one site in Sweden (Proof-of-Concept study). The Pivotal study also included a cross-over option for patients initially randomized to Sham. The majority of patients (over 84%) in all three studies were female. 

The open-label and proof-of-concept studies were followed for 24 months and demonstrated similar safety results as the pivotal study. The pivotal study was followed for 36 months. 


Learn more about who Solesta is appropriate for


REFERENCES

1. Solesta [Package Insert]. Santa Barbara, CA: Palette Life Sciences.

Cerwinka WH, Scherz HC, Kirsch AJ. Endoscopic treatment of vesicoureteral reflux with dextranomer/hyaluronic acid in children. Adv Urol. 2008;513854.

2. Graf W, Mellgren KE, et al; for NASHA Dx study group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, shame-controlled trial. Lancet. 2011;377(9770):977-1003.

3. Rao SS. Diagnosis and management of fecal incontinence. American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99:1585–1604.

4. Rao SS. Current and emerging treatment options for fecal incontinence. J Clin Gastroenterol. 2014;48(9):752-764.

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