ImaJin^® Hydro Ureteral Stent Kits

Patient-Centered Design

• Constructed with soft silicone material
• Clinically proven for greater patient comfort over leading competitor¹
• Greater resistance to encrustation than alternative materials²

Physician-Preferred Placement

• Hydrophilic coating facilitates advancement up the ureter
• Tapered tip to facilitate ease of access
• Graduation markings allow for monitoring of stent advancement

Long-Term Implantation

• Cleared for indwell up to 12 months
• Biodurable construction for prolonged ureteral placement
• Shape memory loop to reduce risk of migration

References:

1. El-Nahas et al, Self-Retaining Ureteral Stents: Analysis of Factors Responsible for Patients’ Discomfort. J of Endourology. Jan. 2006, 20(1):33-37.
2. Bouzidi et al, Characteristics of Encrustation of Ureteric Stents in Patients with Urinary Stones. Progres en urologie. 2008, 18:230-237.

ImaJin^® Silicone Hydro-Coated Double Loop Ureteral Stent Kit Brief Statement

Indications
Silicone Hydro-Coated Double Loop Ureteral Stents are intended for:
Drainage of the upper urinary tract over fistulas or ureteral obstacles. Healing of the Ureter

Contraindications
Untreated progressive infection of the upper urinary tract. The evaluation of the allergic background of a patient is the healthcare professional’s responsibility. Do not attempt stent placement in a patient with suspect ureteral avulsion. Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.

Warnings and Precautions
These kits must only be used by trained and experienced physicians. Formation of knots in lengthy stents have been reported as adverse events and may require surgical intervention to remove them.

Potential Complications
The following events have been reported although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: Migration or dislodgement, encrustation, infection, fragmentation, flank pain, mucosal irritation or inflammation, mucus secretion, frequency, urgency, dysuria, hematuria, reflux, stone formation, obstruction, erosion and perforation of the renal pelvis, ureter or bladder. Some events may be related to this procedure, amongst which those related to the guidewire: ureteral perforation, or burns when in contact with an electrosurgical equipment.

Advice to the Patient
The physician must inform the patient of the risks associated with the use of the device

The risks and benefits of using ImaJin^® Silicone Hydro-Coated Double Lop Ureteral Stent Kit should be considered in patients

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN
February 21, 2023
PM-15976