Description

The Vortek® Ureteral Stent is a specialized medical device designed to facilitate the drainage of the upper urinary tract and support the healing of the ureter. Suitable for both adult and pediatric patients, it addresses various clinical needs such as drainage over fistulas, ureteral obstacles, and temporary drainage in surgical scenarios like ureterostomy or vesical replacement.

Key Features

• Dual Durometer Material: The stent features a stiff inner layer for easier insertion and a soft outer layer to enhance patient comfort and ensure optimal urinary flow.
• Thermosensitive Properties: It remains firm during advancement and softens at body temperature, improving comfort.
• Hydrophilic Coating (Vortek® Hydro): This variant offers a hydrophilic coating that enhances glide, making insertion smoother.
• Shape Memory Loop: Designed to reduce the risk of migration, complemented by graduation markings and radiopaque material for accurate placement confirmation through imaging.

Configurations

Available in single and double loop configurations, the stent includes a rounded distal tip for less traumatic insertion and a retention coil to prevent migration. It comes in various diameters (4.8, 6, 7, and 8 French) and lengths (12 to 30 cm for double loop, up to 90 cm for single loop). The stent is provided with or without a Seldinger guidewire and offers different eye configurations.

Material and Safety

Constructed from biocompatible, radiopaque polymeric materials, the stent is latex-free and may contain traces of silicone, necessitating patient allergy evaluation. It is MRI safe and supplied sterile, intended for single use only.

Duration of Use

Double loop stents are suitable for indwelling periods of up to 6 months, while single loop stents are intended for short-term use of less than 30 days. Proper patient education on monitoring and reporting symptoms is crucial, as is regular medical follow-up.

Contraindications and Precautions

Contraindications include untreated progressive infection of the upper urinary tract, suspected ureteral avulsion, and known allergies to latex or silicone. The device should only be used by trained physicians, with precautions against reuse or reprocessing.

Potential Complications

Possible adverse events include migration, encrustation, infection, pain, and urinary symptoms such as hematuria and obstruction. Patients should be informed of these risks and instructed to report any concerning symptoms promptly.

Regulatory Information

The Vortek® Ureteral Stent is classified as a Class II medical device, restricted to sale by or on the order of a physician. It meets biocompatibility standards and is sterilized using ethylene oxide. Comprehensive mechanical testing ensures its performance, including flow rate, tensile strength, and MRI compatibility.