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Product description

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Product description

The Coloplast® Titan® inflatable penile prosthesis is a self-contained, fluid-filled system made from Bioflex and silicone. Bioflex is a supple, yet durable, biopolymer material. It is designed to emulate the look and performance of a natural erection. Titan is offered in both standard and narrow-base cylinder styles, peno-scrotal or infrapubic approach, and lengths ranging from 10-28cm depending on style.


The Titan penile implant consists of:

  • A reservoir (placed in the abdomen)
  • Two penile cylinders
  • A pump

Each part is connected by silicone tubing. The Titan is MRI Conditional and latex free.


Titan Features:

  • Bioflex® material for unmatched cylinder strength (cf. 1)
  • Lock-out™ valve designed to prevent auto-inflation (cf. 1)
  • Hydrophilic coating to aid in surgical placement (cf. 1)
  • Zero degree angle proximal base input tubing for ease of surgical placement (cf. 2)
  • Soft molded tip designed for suitable anatomic positioning (cf. 3)


Important Safety Information


Indications

The Titan or Titan OTR Inflatable Penile Prosthesis is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.


Contraindications

The Titan and Titan OTR Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following conditions: Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. Patients with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder. Patients unwilling to undergo any further surgery for device revision.


Warnings

Implantation of the device may make latent natural erections, as well as other interventional treatment options, impossible. Men with diabetes or spinal cord injuries, as well as immunocompromised patients, may have an increased risk of infection associated with a prosthesis. Failure to evaluate and promptly treat erosion may result in a substantial worsening of the condition, leading to infection and loss of tissue. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. This device contains solid silicone elastomer. The risks and benefits of implanting this device in patients with lupus, scleroderma, myasthenia gravis, or documented sensitivity to silicone should be carefully considered. The issue of the possible relationship between silicone (and other implantable materials) and various diseases has been the subject of debate.


Precautions

A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.  Surgeons implanting penile prostheses should be familiar with the currently available techniques for measuring the patient, determining implant size, and performing the surgery.


Potential Complications

Scrotal swelling, autoinflaction, discomfort, angulation/curvature, edema, device malfunction/deflation, pain, difficulty with ejaculation, transient urinary retention, faver, mitration, patient dissatisfaction, infection, hematoma  wound leakage, bleeding, delayed wound healing, phimosis, sensory loss cylinder aneurysm, fibrous capsule formation, over/under inflation, erosion, scrotal ertthema, genital change, inguinal hernia
See the device manual for detailed information regarding the implant procedure, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp and/or consult the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
1/31/2013

References:

  1. Data on file.
  2. Köhler TS, Carrion R, et al. Initial evaluations for enhanced Coloplast Titan inflatable penile prosthesis: Results of a multicenter questionnaire. Presented at ISSM/SMS 2012 Annual Meeting, Chicago, IL, USA. August 2012.
  3. Hakky TS, Bradley P, et al. 3D reconstructoin of the corpus cavernosum with comparative 3D analysis of the inflatable penile prosthesis. Presented at ISSM/SMS 2012 Annual Meeting, Chicago, IL, USA. August 2012.
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Product variants

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Product variants

Product name Item number CCode Length (numeric) Order number Units in package Volume
Titan Standard Assembly Kit 519170 91-9480SC 1
Titan Narrow-base Assembly Kit 519180 1
True-Lock Plug (uncoated) 517970 90-9471S 1
Titan Standard Assembly Kit 519170 1
Titan Zero Degree cylinder sets E17928 C1813 28 cm E17928 1
Titan Zero Degree cylinder sets E17924 C1813 24 cm E17924 1
Titan Zero Degree cylinder/pump set. Infrapubic ES8822 C1813 22 cm ES8822 1
Titan Zero Degree cylinder/pump set. Scrotal ES8916 C1813 16 cm ES8916 1
Titan Zero Degree cylinder/pump set. Infrapubic ES8816 C1813 16 cm ES8816 1
Titan Zero Degree cylinder/pump set. Scrotal ES8922 C1813 22 cm ES8922 1
Titan CL (Cloverleaf) Reservoir with Lock-out™ Valve ER8125 C1813 ER8125 1 125 cc
Titan Zero Degree cylinder/pump set. Infrapubic ES8818 C1813 18 cm ES8818 1
Titan Zero Degree cylinder/pump set. Infrapubic ES8820 C1813 20 cm ES8820 1
Titan Zero Degree cylinder/pump set. Scrotal ES8911 C1813 11 cm ES8911 1
Titan Zero Degree cylinder/pump set. Scrotal ES8914 C1813 14 cm ES8914 1
Titan Zero Degree cylinder sets E17926 C1813 26 cm E17926 1
Titan CL (Cloverleaf) Reservoir with Lock-out™ Valve ER8075 C1813 ER8075 1 75 cc
Titan Zero Degree cylinder/pump set. Infrapubic ES8811 C1813 11 cm ES8811 1
Titan Zero Degree cylinder/pump set. Infrapubic ES8814 C1813 14 cm ES8814 1
Titan Zero Degree cylinder/pump set. Scrotal ES8918 C1813 18 cm ES8918 1
Titan Zero Degree cylinder/pump set. Scrotal ES8920 C1813 20 cm ES8920 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8810 10 cm 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8814 C1813 14 cm 90-9814INC 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8810 C1813 10 cm 90-9810INC 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8818 18 cm 1
Titan Narrow-base cylinder/pump set. Scrotal QN8910 C1813 10 cm 90-9910SNC 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8814 14 cm 1
Titan Narrow-base cylinder/pump set. Scrotal QN8910 10 cm 1
Titan Narrow-base cylinder/pump set. Scrotal QN8918 18 cm 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8812 C1813 12 cm 90-9812INC 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8816 16 cm 1
Titan Narrow-base cylinder/pump set. Scrotal QN8912 12 cm 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8812 12 cm 1
Titan Narrow-base cylinder/pump set. Infrapubic QN8816 C1813 16 cm 90-9816INC 1
Titan Narrow-base cylinder/pump set. Scrotal QN8912 C1813 12 cm 90-9912SNC 1
Titan Narrow-base cylinder/pump set. Scrotal QN8916 16 cm 1
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Alternatives and accessories

Titan® OTR

Titan® OTR

Titan® OTR is designed to emulate the look and performance of a natural erection.

View Titan® OTR
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