The Synergo® system has been successfully used in leading medical centers in the
European Community and Israel. Hundreds of patients have been treated during
the years and were carefully monitored for any side effects and complications.
Most side effects and complications witnessed are well known and have been
reported with intravesical chemotherapy instillations (without hyperthermia).
Side effects that were observed (see table) were transient events that normally had no
lasting effect on bladder function, superficial, resolved with minimal medical
intervention and without significant residual effects during the course of the treatment.
The complications observed were successfully treated with standard procedures.
Similar side effects were witnessed during Adjuvant (Prophylactic) and Neo-Adjuvant
(Ablative) Synergo® treatments.
Safety data for Patients treated with Synergo® system and MMC in the European Community and Israel
Following is a table presenting the side effects and complications reported according
to the percentage of patients treated or according to percentage of treatment sessions,
as appropriate. The safety data is presented in the following table for all patients treated.
Adverse event * :
% Patients / Treatments
Patients
Treatment sessions
Posterior Wall Thermal Reaction
20.4%
Skin MMC allergy
5.4%
Urethral Stenosis
5.4%
Bladder Wall Necosis
5.9%
Bladder Stone
0.5%
False route
0.5%
Pain (including spasm)
18.6%
Dysuria
7.6%
Urge and/or incontinence
2.1%
Hematuria
2.8%
Traumatic catheter insertion
1.1%
Urinary frequency/urgency
1.3%
Urinary Tract Infection
0.4%
Nocturia
0.5%
* (The above safety data is based on patients treated with Synergo®
system and MMC in the European Community and Israel, post CE data)
Analyzing the safety data proves that the Synergo® hyperthermia and chemotherapy
treatment does not cause any major complications, other than those anticipated
events that occur due to the nature of urinary bladder catheterization,
hyperthermia and chemotherapy treatment.
Therefore, treatment administered with the Synergo® system can be
considered safe and does not pose risk to the patient or to the operator.
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
