VersaPulse® PowerSuite™ Holmium Lasers

Refer to the operator's manual for complete instructions for use.

Federal (USA) law and governing law outside the USA restrict these devices to sale by or on the order of a physician.

Urology contraindications
The Ho:YAG wavelength should not be used for HoLRP for treatment of BPH in patients with:

• Carcinoma of the prostate
• Desire for future fertility

The Ho:YAG wavelength should not be used in patients with the following conditions:

• Inability to receive endoscopic treatment
• Intolerance to anesthesia

Trademark
Legal Manufacturer: Lumenis. Ltd. Distributed in the U.S. by: Boston Scientific Corporation. VersaPulse, VersaPulse Select, PowerSuite and Duotome are trademarks of Lumenis Ltd

Urology indications:
The following applications are indicated for urology while using the Ho:YAG wavelength:

• Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate(HoLRP),hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH). The clinical procedure for HoLRP, along with clinical study results, is described in Appendix A of the operator manual.
• Open and endoscopic urological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of:
  • Superficial and invasive bladder, urethral and ureteral tumors
  • Condylomata
  • Lesions of external genitalia
  • Urethral and penile hemangiomas
  • Urethral strictures
  • Bladder neck obstructions

Warnings
Refer to operators manual provided with product for a complete list of warnings.

General warning:
Lasers generate a highly concentrated beam of light which may cause injury if improperly used. To protect the patient and operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.

Urology warnings:
Good clinical judgement should be used prior to performing the HoLRP procedure on patients who are taking anticoagulants.

General laser complications:
Refer to complications specific to each surgical specialty and wavelength in the "Directions for Use". The potential complications encountered in endoscopic laser surgery are the same as those normally encountered in conventional endoscopic surgery. 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 leukocytosis, which are commonly associated with tissue destruction. These generally resolve without treatment. Laser ablated tissue may become necrotic or infected after treatment If a question of infection exists, 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. Posttreatment hematocrits are recommended to identify this potential complication.
• Sepsis can result from performing any surgical procedure. If a question of sepsis exists, appropriate evaluations should be made.
• Perforation may occur as a result of laser treatment. To diagnose perforations, patients must be carefully followed post-operatively with appropriate tests.

Urology precautions:
The following precautions are suggested when using the Ho:YAG wavelength in urology:

• Care should be exercised so as not to over distend the bladder when using the laser endoscopically. Excessive bladder distention could result in coagulative necrosis of the superficial and inner muscular region of the bladder wall.

The following precautions are recommended for HoLRP for treatment of BPH:

• Confirm that the tip of the fiber optic delivery device extends at least 1.25 centimeters beyond the end of the urethroscope or endoscope during laser treatment.
• Activating the laser when the tip of the delivery device is within the urethroscope or endoscope can result in penetration of holmium laser energy through the scope and destruction of the scope.
• Use caution during laser treatment near the verumontanum.
• The learning curve to obtain proficiency in HoLRP has been described by experienced urologists to be similar to that of learning TURP

Read “Directions for Use” for a list of additional precautions.