Overview of Solesta - Palette Life Sciences
Solesta is made of frequently used biocompatible material with an established safety profile
Solesta is a biocompatible tissue bulking agent injected into the submucosal layer of the anal canal.
Solesta is made from polysaccharides that have been in medical use for over two decades in more than 40 million medical procedures worldwide. (1)
EASILY INJECTABLE, VISCOUS GEL MADE FROM TWO POLYSACCHARIDES (2)
Non-Animal Stabilized Hyaluronic Acid (NASHA) undergoes a process to form a gel with increased viscosity and stability
Dextranomer (Dx) microspheres measure between 80 μm and 250 μm
The NASHA/Dx implant is stable, remains in position, and does not disappear over time3
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.
THE BEADS PROVIDE A FRAMEWORK FOR FIBRIN AND COLLAGEN DEPOSITION, EVENTUALLY FORMING DURABLE, TISSUE-LIKE FORMATIONS IN THE ANAL CANAL (4)
Solesta is injected into the submucosal layer of the anal canal. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal, allowing for better sphincter control. (2)
SOLESTA PROCEDURE BENEFITS (2)
A quick, nonsurgical outpatient procedure
No anesthesia is required
Injected via simple anoscopy
SOLESTA HAS MINIMAL POST-PROCEDURE IMPACT ON PATIENTS (2)
Patients may resume limited physical activity immediately
Patients are able to resume a normal lifestyle and engage in all physical activities after 1 week (e.g. jogging, bicycling, horseback riding, sexual intercourse, etc.)
Solesta is unlikely to impede future procedures
SOLESTA EFFICACY HIGHLIGHTS (2)
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 STUDIES (2)
Clinical data supporting the safety and effectiveness of Solesta are available from three clinical studies: (2)
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 dependable results with Solesta
1. Data on file.
2. Solesta [Package Insert]. Santa Barbara, CA: Palette Life Sciences.
3. Cerwinka WH, Scherz HC, Kirsch AJ. Endoscopic treatment of vesicoureteral reflux with dextranomer/hyaluronic acid in children. Adv Urol. 2008;513854.
4. Stenberg A, Larson E, Läckgren G. Endoscopic treatment with dextranomer-hyaluronic acid for vesicoureteral reflux: histological findings. J Urol. 2003;169(3):1109-1113.