CoreTherm^® Patient Specific Thermal Therapy is a non-surgical device intended as an in-office treatment for patients with BPH. It is suitable for a wide variety of patients including patients with urinary retention, non-catheterized patients and patients with large prostates. A urethrocystoscopy is recommended for the CoreTherm^® treatment to rule out a protruding median lobe, deformity in the bladder neck, bladder stones, stricture and bladder cancer, previous TUMT or TURP.

 Indications

• Symptomatic BPH.

• Prostate Size between 30 and 100 grams and prostate length > 35mm.

 Contraindications

• Urethral Stricture.

• Patient with penile or urinary sphincter implants.

• Patients who have undergone pelvic radiation therapy.

• Patients with implanted active devices, including pacemakers or defibrillators that are within 2.6 inches (6.5 cm) from the prostatic urethra.

 Important Safety Information

The safety and effectiveness of CoreTherm^® has not been established in patients with prostate cancer, active prostatitis, urinary tract infection, significant median lobe or bladder neck sclerosis, previous prostate or rectal surgery, neurogenic LUT disorder, interest in the preservation of fertility and/or patients with implanted, active pacemakers or defibrillators.