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Product description

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Product description

Titan® OTR Inflatable Penile Prosthesis a self-contained, fluid-filled system made from Bioflex and silicone. Bioflex is a supple, yet durable, biopolymer material. It was designed to emulate the look and performance of a natural erection. The implant provides voluntary control over the erect and flaccid states of the penis with a one-touch release. The Titan OTR is designed for ease of patient training, easier product deflation and a quicker return to a flaccid state. (cf. 1,4)

Titan OTR 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 OTR penile implant consists of:

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

Each part is connected by silicone tubing. The Titan OTR is MRI Conditional and is not made with natural rubber latex.


Titan OTR Features:

  • Bioflex® is a supple, yet durable, biopolymer material.
  • Lock-out™ valve designed to prevent auto-inflation (cf. 1)
  • Hydrophilic coating to aid in surgical placement (cf. 1)
  • One Touch Release (OTR) for easy deflation of the device (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.
 
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.
  4. Quallich SA, Ohl DA, Dunn RL. Evaluation of three penile prosthesis pump designs in a blinded survey of practitioners. Urologic Nurs. April 2008;28:101-108.
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Product codes

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Product codes

Product name Item Number CCode Length Order number Eaches/Box
Titan® Pump Assembly 517770 C1813 1
Titan® Touch Pump Assembly 517750 C1813 1
Titan® OTR Pump Assembly 517780 C1813 1
Titan OTR Zero Degree cylinder/pump set Infrapubic ESR818 C1813 18 cm ESR818 1
Titan OTR Zero Degree cylinder/pump set Infrapubic ESR820 C1813 20 cm ESR820 1
Titan OTR Zero Degree cylinder/pump set Scrotal ESR914 C1813 14 cm ESR914 1
Titan OTR Zero Degree cylinder/pump set Infrapubic ESR814 C1813 14 cm ESR814 1
Titan OTR Zero Degree cylinder/pump set Scrotal ESR918 C1813 18 cm ESR918 1
Titan OTR Zero Degree cylinder/pump set Scrotal ESR920 C1813 20 cm ESR920 1
Titan OTR Zero Degree cylinder/pump set Infrapubic ESR822 C1813 22 cm ESR822 1
Titan OTR Zero Degree cylinder/pump set Scrotal ESR916 C1813 16 cm ESR916 1
Titan OTR Zero Degree cylinder/pump set Infrapubic ESR816 C1813 16 cm ESR816 1
Titan OTR Zero Degree cylinder/pump set Scrotal ESR922 C1813 22 cm ESR922 1
Titan OTR Narrow-base cylinder/pump set Infrapubic QNR816 C1813 16 cm 90-9816INCOTR 1
Titan OTR Narrow-base cylinder/pump set Infrapubic QNR812 C1813 12 cm 90-9812INCOTR 1
Titan OTR Narrow-base cylinder/pump set Scrotal QNR912 C1813 12 cm 90-9912SNCOTR 1
Titan OTR Narrow-base cylinder/pump set Scrotal QNR916 C1813 16 cm 90-9916SNCOTR 1
Titan® cylinder/pump set Scrotal QSR922 C1813 22 cm 1
Titan OTR Narrow-base cylinder/pump set Infrapubic QNR810 C1813 10 cm 90-9810INCOTR 1
Titan OTR Narrow-base cylinder/pump set Infrapubic QNR818 C1813 18 cm 90-9818INCOTR 1
Titan OTR Narrow-base cylinder/pump set Scrotal QNR914 C1813 14 cm 90-9914SNCOTR 1
Titan® OTR cylinder/pump set Infrapubic QSR814 C1813 14 cm 1
Titan® cylinder/pump set Scrotal QSR918 C1813 18 cm 1
Titan® cylinder/pump set Scrotal QSR920 C1813 20 cm 1
Titan OTR Narrow-base cylinder/pump set Infrapubic QNR814 C1813 14 cm 90-9814INCOTR 1
Titan OTR Narrow-base cylinder/pump set Scrotal QNR910 C1813 10 cm 90-9910SNCOTR 1
Titan OTR Narrow-base cylinder/pump set Scrotal QNR918 C1813 18 cm 90-9918SNCOTR 1
Titan® OTR cylinder/pump set Infrapubic QSR818 C1813 18 cm 1
Titan® OTR cylinder/pump set Infrapubic QSR820 C1813 20 cm 1
Titan® cylinder/pump set Scrotal QSR914 C1813 14 cm 1
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Alternatives and accessories

Titan®

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

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