Description
The IRRIGATION SETS BULKAMID DEMO is an integral component of the Bulkamid Urethral Bulking System, specifically designed for medical professionals treating stress urinary incontinence (SUI) in adult women. This specialized irrigation set plays a crucial role in maintaining a clear surgical field, facilitating the precise placement of Bulkamid hydrogel injections during urethral bulking procedures.
Key Components
- Bulkamid Hydrogel Syringes: Includes two prefilled 1 mL syringes of Bulkamid Hydrogel, known for its non-resorbable and biocompatible properties. The hydrogel's composition ensures it remains in place, providing long-term effectiveness.
- Needles and Sheath: Comes with two 23G needles and a rotatable sheath, allowing for accurate delivery and positioning of the hydrogel.
- Irrigation System: The attached irrigation system is compatible with standard infusion sets, using sterile water to ensure clear visualization throughout the procedure.
Design and Compatibility
The irrigation components are designed for compatibility with the Bulkamid cystoscope and rotatable sheath, enhancing the clarity and accuracy of hydrogel placement. The system's design allows for the irrigation components to be reusable, with sterilization options including autoclaving or using the STERRAD® System.
Administration and Use
This device is intended for use by qualified physicians such as gynecologists, urologists, and urogynecologists. Proper administration involves specific pre-operative measures, including patient positioning, local anesthesia, and recommended prophylactic antibiotics. The hydrogel is injected into the submucosal tissue of the proximal urethra at strategic sites to improve urethral coaptation.
Sterilization and Maintenance
Single-use components, including syringes, needles, and the sheath, must not be reused or re-sterilized. The irrigation components, however, can be effectively sterilized, ensuring they are safe for repeated use.
Contraindications and Precautions
The use of this system is contraindicated in patients with certain conditions such as acute urinary tract infections, damaged urethral tissue, and specific medical conditions like poorly controlled diabetes. It is not intended for use in men or individuals under 18 years of age. Physicians are advised to take precautions to mitigate risks such as vascular occlusion and tissue damage.
Post-Procedure Care
Following the procedure, patients are generally able to resume normal activities within 24 hours. Residual urine measurement is recommended, and additional injections may be scheduled if necessary, typically 4 to 6 weeks apart.
This device is restricted to sale and use by, or on the order of, a physician, in accordance with U.S. Federal law, ensuring it is administered by qualified healthcare professionals only.
