The Synergo® System enables two treatment modalities for Superficial Transitional Cell Carcinoma of the urinary Bladder.
Adjuvant (Prophylactic) Treatment - aimed to prevent tumor recurrence after complete Transurethral
Resection of Bladder Tumor (TURBT) in intermediate or high-risk patients, according to the European
Association of Urology guidelines**.
Pathological Stage Ta-T1, papillary or solid, STCCB. Pathological Grade I-III and CIS.
The treatment consists of 6 weekly sessions to be followed by maintenance sessions (every 6 weeks).
Neo-adjuvant (Ablative) Treatment - aimed to eradicate tumor/s. For patients, in whom complete
tumor eradication cannot be achieved in a single TURBT (Multiple sites and/or high tumor burden);
who are unable to undergo anesthesia for medical reasons; who remain tumor positive in spite of
radical TURBT or for unresectable tumor due to anatomic inaccessible location.
The treatment begins with 4 weekly sessions, afterwhich response criteria is verified by video-cystoscopy and biopsies.
If partial-response is achieved, the pateint will continue 4 more weekly sessions. When complete response, patient will begin adjuvant treatment modality.
Each treatment is composed of two thirty minutes cycles, each consists of intravesical instillation of mitomycin
C (in ablative or prophylactic dosage) dissolved in 50 cc of sterile distilled water combined with hyperthermia
at 42±2°C delivered by the Synergo® System.
* (Low-risk: single, Ta, G1, < 3 cm diameter; High-risk: T1, G3, multifocal
or highly recurrent, CIS;
Intermediate-risk: all other tumors, Ta-T1, G1-G2, multifocal, > 3cm diameter)
Medical Enterprises Europe B.V.
Assumburg 152B
1081GC, Amsterdam, The Netherlands
Tel: +31 (0) 20 6423719
Fax: +31 (0) 20 6421161
R&D Center:
MEL Medical Enterprises Ltd.
6 Odem St. P.O.B. 7166
Petah-Tikva, 49170, ISRAEL
Tel: 972 3 9244830
Fax: 972 3 9245340
