Interventional Urology

Coloplast TFL Drive Brief Statement

Indications

The Coloplast TFL Drive laser device and its accessories are intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: Urology, Lithotripsy, Gastroenterological Surgery and Gynecological Surgery. Refer to the Coloplast TFL Drive User Manual for specific indications within these surgical specialties.

Contraindications

The use of the laser is contraindicated:

• In patients whose general medical condition contraindicates surgical intervention.
• When appropriate anesthesia is contraindicated by patient history or inability to receive anesthesia.
• Where tissue (especially tumors) is calcified.
• For hemostasis of vessels with diameters over approximately two millimeters.
• Where laser therapy is not considered the treatment of choice.
• In patients who have recently undergone radiotherapy. Such patients may be at greater risk of tissue perforation or erosion.
• In patients unable to receive endoscopic treatment.
• In patient suffering from bleeding disorders and coagulopathy.
• Diagnosed with acute or chronic prostatitis, prostate cancer, or severe urethral stricture.
• Diagnosed at the time of treatment with acute or chronic urinary tract infection.

Other considerations requiring Physician's clinical judgement:

• Patients with compromised renal function or upper urinary tract obstructive diseases.
• Patients who still wish to have children.
• Patients with an ASA classification of physical status 5.
• Patients with a prostate gland > 120g.

Refer to the Coloplast TFL Drive User Manual for specific contraindications when undergoing URS, PCNL, Gynecology, Gastroenterology and Lithotripsy surgical procedures.

Warnings

The Coloplast Drive Laser System is a surgical device that should be used only by physicians or surgeons who have been thoroughly trained in laser surgery. Surgeons using Coloplast TFL Drive Laser System must understand the laser’s unique properties prior to using the device. 

As with conventional endoscopic surgery, the possibility of complications and adverse events (such as chills, fever, edema, hemorrhage, inflammation, tissue necrosis or infection) may occur following treatment. In extreme cases, death may occur due to procedural complications or concurrent illness.

The manufacturer has no clinical information or experience concerning the use of the Laser System on pregnant women or nursing mothers. As with conventional non-laser surgical procedures, there is no guarantee that treatment with the Laser System will entirely eliminate the disease. Repeated treatment or alternative therapies may subsequently be required. The laser may not be effective for coagulation in massive haemorrhage situations. The surgeon must be prepared to control haemorrhages with alternative non-laser techniques, such as ligature or cautery.

Potential Complications

Complications and risks are the same of the conventional laser surgery. Refer to the Coloplast TFL Drive User Manual for specific potential complications when undergoing endoscopic urology procedures (URS, PCNL, Gynecology, Gastroenterology and Lithotripsy). 

Acute pain may occur immediately following laser therapy and may persist for as long as 48 hours. Immediately following laser therapy, the patient may experience fever and leucocytosis, which are commonly associated with tissue destruction. These generally resolve without treatment. Laser ablated tissue may become necrotic or infected after treatment. In case of concerns about any possible infection, 
appropriate treatment should be carried out.

The following complications could be serious and could result in death:

• Patients may experience bleeding at the site of laser therapy. Haematocrit analysis after treatment is recommended to identify this potential complication.
• Sepsis can result from performing any surgical procedure. In case of concerns about any possible sepsis, appropriate evaluations should be made.
• Perforation may occur as a result of laser treatment. In order to diagnose perforations, patients must be carefully followed post-operatively with appropriate tests.

Additional complications include aspiration, allergic reaction to medication, hypertension, arrhythmia, distension due to gases, pneumothorax, ulceration, edema, chills, healing delay and embolism, which may be thermally or non-thermally induced. There may be urine leakage following the laser procedure. 
The use of flexible endoscopes carries a risk of stricture formation. Although rare, loss of a kidney may occur as a result of the procedure or because of the stone itself.

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.

PM-21981, February 2025

TFL Single-use & Reusable Optical Fibers Brief Statement 

Indications 

Optical Fibers are indicated for use in general surgical applications such as: incision, excision, vaporization, ablation, hemostasis, coagulation of soft tissue and stone treatment in a contact semi-contact or non-contact mode. Applications are defined by the intended use of the surgical laser device, while optical fibers cannot be associated to any specific application. Laser techniques are most commonly applied in surgical fields such as Urology, Gastroenterology, Arthroscopy, Spine surgery, Gynecology, ENT, and General Surgery. 

Indications are the ones that the laser claims, while fibers cannot be associated to any specific indication. 

Contraindications 

For warnings, cautions, contraindications, and clinical use of the fiber refer to the medical laser device User Manual.  Optical Fibers are contraindicated for treatment of patients for whom endoscopic procedures are contraindicated. Medical opinion is critical to determine if a patient can withstand a laser treatment, considering also the contraindications related to the specific clinical applications. 

Warnings & Precautions 

This product shall be used by trained and qualified users only. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use. Reusable Optical Fibers should not be used on patients with confirmed or suspected Transmissible Spongiform Encephalopathies (TSEs).  

For Single-use Optical Fibers Only: Reuse, re-processing, or re-sterilization may compromise the structural integrity of the device and/or lead to a device failure or create risk of contamination. This may result in patient injury, illness or death, or in transmission of infectious disease from one patient to another.  

Potential Complications 

Refer to the laser system User Manual for specific instructions concerning warnings, cautions, contraindications, and clinical use of the laser.   Complications that could occur during laser treatments include: • local and/or systemic infection • thermal damage • local hematoma • dissection and perforation • tissue adhesion • Pain. 

Note: It is possible that the optical fiber tip breaks off during use. 

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.  

PM-21989, July 2024 

Titan® & Titan Touch Inflatable Penile Prosthesis Important Safety Information 

The Titan Inflatable Penile Prosthesis is a surgically implanted mechanical penile implant intended for the treatment of erectile dysfunction in men. The Titan implant is a 3-piece fluid-filled system manually operated to produce and sustain an erection for sexual intercourse.

Indications  

The Titan Inflatable Penile Prosthesis is indicated for male patients with erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.

Contraindications 

The Titan implant is not for use in patients who have one or more of the following conditions: 1) have an active infection, particularly urinary tract or genital infection, 2) are sensitive or allergic to silicone or polyurethane, 3) have ongoing difficulty urinating or emptying the bladder (e.g., bladder outlet obstruction or neurogenic bladder), or 4) unwilling to undergo any further surgery for device revision. 

Warnings 

Patients should consider the warnings, precautions and potential complications associated with the use of this product, which may include the following: potential for resurgery (note: device is not a lifetime implant). Implantation makes latent natural erections, as well as other interventional treatment options, impossible. Implantation may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. Diabetic, as well as immunocompromised patients, may have an increased risk of infection which could result in permanent damage to tissue/organs. Excessive stresses from rigorous exercise and vigorous masturbation/intercourse could lead to device damage. Certain stresses and pressures (straddle seating, obesity, etc.) could lead to involuntary inflation or deflation. Post-implant penile size, girth and angle can vary based on patient anatomy, implant size, level of inflation, and presence of Peyronie’s disease. 

Precautions 

Patients with spinal cord injury may have an increased risk of infection. This device may be used to treat erectile dysfunction in the presence of Peyronie’s disease. Although the implant is not visible, depending on the placement (submuscular) the reservoir may be palpable. 

Patients should consider the following factors which could lead to increased risk of failure and can be critical to the eventual success of the procedure: ability and willingness of the patient to follow instructions; associated psychological status (e.g., psychogenic erectile dysfunction, inappropriate attitude or motivation); health conditions which hamper sexual activity (such as severe angina) may prevent successful use of this device; manual dexterity problems; and lack sufficient manual dexterity or strength necessary to operate the device. 

Impact injuries to the pelvic or abdominal areas (e.g., sports injuries) can result in damage to the implant which may necessitate replacement of the device. Contracture of tissue around the pump can cause unnatural firmness in the scrotum and involuntary inflation or deflation. The device may fail to deflate and/or deflation of the device may be slow or difficult for some patients. Device malfunctions may result in the inability to inflate or deflate the device. Removal of the device without timely reimplantation of a new implant may complicate subsequent reimplantation. 

Potential Complications 

Adverse events are known to occur with penile protheses procedures and implants; some may require revision surgery or removal of the implant. Adverse events following penile protheses implantation may be new onset (de novo), persistent, worsening, transient, or permanent. 

Adverse events may include but are not limited to: inability to pull foreskin back from tip of uncircumcised penis (acquired phimosis); abnormal wound healing/adhesion/scar tissue; bladder storage symptoms/urinary retention; tightening, shortening, deformity or curvature of penis (capsular contracture, induration); discomfort/pain; injury to tissue or organs (perforation/erosion/extrusion) resulting in damage or loss of tissue (necrosis); open tunnel between tissue or organs (fistula); foreign body reaction/allergic reaction/sensitivity; bleeding/hemorrhage or collection of blood or fluid outside of tissue or vessels (hematoma/seroma); hernia; Infection/urinary tract infection; redness or swelling (inflammation/edema); difficult or painful intercourse (dyspareunia/sexual dysfunction); obstruction/occlusion; numbness or decreased sensation (e.g., hypoesthesia); and urinary incontinence. The occurrence of these events may require one or more subsequent surgeries which may or may not always fully correct the complication. 

This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if an inflatable penile implant is right for you.  

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

PM-15451 / Feb 2024 

Virtue® Male Sling System Important Safety Information 

Virtue Male Sling is a polypropylene mesh device or “sling” intended to prevent involuntary urine leakage (incontinence) at times of increased pressure on the bladder (e.g., coughing, sneezing, laughing, lifting heavy objects, exercise). It is permanently implanted to support, elevate and gently compress the urethra, the tube that connects to the bladder to carry urine outside of the body. 

Indications 

The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI). 

Contraindications 

The Virtue Male Sling is contraindicated in patients with one or more of the following conditions: 1) documented hypersensitivity or allergic reaction to polypropylene, 2) active infection, including untreated urinary tract and/or infection in the operative field, 3) patients with untreated or serious blood clotting (coagulation) disorders, 4) patients with blockage of urine flow (obstructive uropathy), 5) patients under the age of 18. 

Warnings 

Your physician will conduct a complete evaluation with testing to confirm you are a candidate for a male sling. Patients will then be advised prior to surgery, of the warnings associated with the use of this product, the associated surgical and postoperative risks and potential complications. Sling associated complications may result in resurgery which may lead to partial or complete removal of the sling. Complete removal of the sling may not always be possible, and removal may not fully correct these complications. New onset (de novo) complications may occur. As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, sling exposure or other complications and adverse events. The risk versus benefit of the male sling should be considered in patients with one or more of the following conditions: auto-immune disease, blood clotting (coagulation) disorder, connective tissue disease, impaired immune system (debilitated or immunocompromised state), diabetes, pelvic radiation therapy, physical characteristics (e.g., body mass index), kidney problems (renal insufficiency), smoking related conditions (e.g., COPD, chronic cough). 

Potential Complications 

Adverse events are known to occur with sling procedures and implants. Adverse events following sling implantation may be immediate or delayed, localized or systemic, new onset (de novo) or worsening, acute or chronic, transient or permanent. 

Adverse events may include but are not limited to: allergic reaction, hypersensitivity; abnormal immune response (autoinflammatory/autoimmunity syndrome); bladder symptoms (e.g., increased daytime frequency, urgency, nocturia (urinating more than once per night), overactive bladder, urinary incontinence); bleeding/hemorrhage; delayed/impaired/abnormal wound healing; exposure, extrusion or erosion of sling into other structures or organs; fistula formation (abnormal connection or passageway between two structures in the body); foreign body granuloma (abnormal tissue formation)/scar tissue formation; genital burning / tingling / numbness (paresthesia); infection; tissue swelling/redness/discomfort (inflammation/irritation); avoidance/difficult/painful intercourse (dyspareunia / sexual dysfunction); tissue death (necrosis); weakness or loss of sensation (neuromuscular disorder); palpable mesh; pain; perforation or injury to adjacent muscles, nerves, vessels, structures, or organs (e.g., bone, bladder, urethra, ureters, bowel); collection of clear fluid or blood outside of tissue or vessels (seroma/hematoma); sling migration; urinary tract infection; inability to completely empty bladder (urinary tract obstruction); voiding symptoms (e.g., dysuria (painful urination), urinary retention, incomplete emptying, bladder outlet obstruction, straining, position-dependent voiding, slow stream). 

This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a male sling is right for you.  

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

PM-15544 / Apr 2024 

Altis® Single Incision Sling System Important Safety Information 

Stress urinary incontinence is a condition in which urine involuntarily leaks at times of increased pressure on the bladder (e.g., coughing, sneezing, laughing, lifting heavy objects, exercise). Stress urinary incontinence can be treated with a surgical procedure in which a mesh sling is implanted to act as a "hammock" to support the urethra, the tube that connects to the bladder that carries urine outside the body. An incontinence sling surgery involves anesthesia and may require an overnight hospital stay. 

The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from the urethra not closing properly (urethral hypermobility) and/or weakness of the urethral sphincter (intrinsic sphincter deficiency (ISD)). 

Your physician should advise that the Altis Single Incision Sling System is not for females who have the following:   are pregnant or have desire for future pregnancy • potential for further growth (e.g., adolescents) • known active urinary tract infection and/or infection in operative field • taking blood thinning medication (anti-coagulant therapy) • abnormal urethra (e.g., fistula, diverticulum) • any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement, and • sensitivity/allergy to polypropylene or polyurethane. 

Discuss with your physician: 

• The reason for choosing a mesh sling including the warnings, precautions and risks associated with its use 
• Alternative incontinence treatments that may be appropriate 
• The Altis sling to be implanted is permanent  
• Serious mesh associated complications may result in one or more revision surgeries 
• Partial or complete removal of the mesh may not always be possible or advisable as it may not fully correct these complications 
• New onset (de novo) complications and recurring or worsening SUI can occur 
• There may be unresolved pain with or without mesh explant and varying degrees of scarring may occur 
• Certain underlying conditions  may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, mesh sling exposure or other complications 

Potential additional risks versus benefits of using Altis should be considered in patients with one or more of the following:  age-related underlying conditions • autoimmune disease • coagulation disorder • connective tissue disorder • debilitated or immunocompromised state • diabetes • pelvic radiation therapy or chemotherapy • physical characteristics (e.g., body mass index) • renal insufficiency • smoking-related underlying conditions, or • urinary tract anomalies.  

Any future pregnancy could negate the benefits of this surgical procedure.  Patients should report bleeding, pain, abnormal vaginal discharge or signs of infection at any time.  

Complications are known to occur and may be immediate or delayed, localized or systemic, new onset (de novo) or worsening, acute or chronic, transient or permanent, new onset (de novo) or continuing, worsening, transient, or permanent. 

Potential complications may include but are not limited to:  

This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a mesh sling is right for you. 

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

Minneapolis, MN 

PM-03328 02/2024