COMING SOON
CLINICAL DATA & SAFETY
Starting as early as 1992 and continuously to date clinical trials have been conducted to study the benefits of combined treatment of Synergo® over chemotherapy and immunotherapy alone for people who suffer from NMIBC.
-
Provides a uniform and prolonged contact of the bladder walls with the drug, thus enhancing the effectiveness of the treatment.
-
Produces homogenous diffused microwave radiation and controlled temperature thermal elevation of the bladder tissue. The radiation exerts a direct and selective effect on tumors and activates an antitumoral effect of the heated drugs. This is a selective effect on tumors that causes necrosis (i.e. kills the tumors) of the necessary tissue while safeguarding the normal tissue.
-
Allows the drug solution to be kept at optimal conditions throughout the treatment session in terms of volume, concentration and temperature.
-
Increases drug penetration by 5-10 times more, accelerating the reaction rate by a factor of 10-50.
The Synergo® system has been successfully used in leading medical centres routinely since 2001. Thousand of patients have been treated over the years and were carefully monitored for any side effects and complications. Most side effects and complications witnessed are well known and have been documented and were published in leading scientific journals. Side effects that were observed 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.
EXPERTS SHARE
Prof. Dr. med. J.A. Witjes PhD MD
Radboud UMC, Nijmegen, The Netherlands
“I have seen remarkable responses in these patients in spite of their being in the list for a cystectomy”
Dr. med. Gerson Lüdecke Head of Uro-Oncology section
University Clinics of Giessen-Marburg, Germany
"Synergo is a pioneering therapy ready for fast track implementation in urology. With more than 10 years of Synergo experiences in high risk NMIBC we achieved minimal recurrence rates using it alternatively to BCG with negligible side effects, and in BCG-failing patients who were externally discussed for cystectomy, we were impressed with the high bladder preservation rate"
Prof. Dr. med. Sanjeev Madaan PhD MS Dip NB FRCS (urol) FEBU
Dartford and Gravesham NHS Trust, Kent , UK
"I have been using Synergo RITE for many years and have found it extremely useful in the management of high-risk NMIBC patients who have failed intravesical BCG and are not keen or suitable for cystectomy"
Mr Ahmed Ali
MBChB, MSc Urology, FRCS Urol
Frimley Health NHS Foundation Trust UK
"The Synergo system has helped us deliver individualised cancer care for patients with high risk NMIBC. The long-term data supports the use of the technology in many indications and help patients making an informed choice in respect to bladder preservation treatment"
Prof. Dr. med. Renzo Colombo FEBU, BC Head of Lombardy Oncology Network
San Raffaele Hospital, Milan, Italy
"I have been working with the Synergo technology since it's development, and for over 20 years have seen very pleasing results in terms of oncological outcome and in the patients 'quality of life"
Prof. Dr. med. Shahrokh F. Shariat PhD MD
Professor and Chairman of Department of Urology, Medical University Vienna, Austria
“Having witnessed its clinical benefits for several years, I think that Synergo will play a significant role in the management of NMIBC.”
Prof. Dr. med. Ofer Nativ PhD MD,
Chairman of Urology Department Bnai-Zion Medical Center, Haifa, Israel
“I have been using Synergo technology for over a decade now and I am satisfied with the results, especially in high risk patients (CIS, T1, high grade and BCG failures). I was able to appreciate its ablative potency and remarkably low dropout rate.”
Prof. Dr. med. Dr. phil. Thomas Bschleipfer FEBU, PhD MD,
Head Urology Department
Klinikum Weiden, Weiden, Germany
“The Synergo® RITE is a highly effective instrument to lower the otherwise extraordinary hazard of high risk NMIBC. It assures an excellent treatment response and thus, gives many of our patients a much better quality of life.”
Mr Rami Issa MD FRCS (Urol) CABU FEBU
St George's University Hospitals, London, UK
"For more than 10 years in our hospital, Synergo proved to be a very helpful option for the difficult group of approx. 200 patients, so far, with High Risk NMIBC, who did not respond to other intravesical therapies. We've saved many bladders over these 10 years!"
THE SCIENCE BEHIND RF ENERGY
Synergo combines local radio-frequency (RF) energy (the lower limit of microwave electromagnetic radiation) with simultaneous instillation of a cooled chemotherapeutic drug.
The target of the RF energy is to enable higher drug penetration and accelerate drug-DNA reactions.
Tissue RF radiation should be adjusted per patient and dynamically maintained during treatment while the tissue temperature is constantly measured and closely followed, against the blood flow's active cooling.
Since the bladder wall acts as a good thermal insulator, heat penetration from heated liquid is not efficient (conduction/convection heating). On the other hand, during microwave heating the energy is absorbed directly in the tissue to enable efficient homogeneous heating, real-time measurement and follow-up on the tissue temperature (as confirmed on 5 different locations in a Synergo treatment) and dynamic adjustment of the transmitted energy (W) for each patient over time (e.g. when blood flow in tissue is increased due to heating).
Published papers show that RF radiation is a a key protagonist in the Synergo treatments. RF is not limited to its hyperthermic property; the drug's molecules diffuse actively by the Foucault currents associated with RF radiation (giving a higher probability of DNA-drug bonding at any given second). Radiated by RF, cancer cells also change their phenotype, characteristics, and their ability to repair themselves.Their membranes become permeated by micropores enabling an increased uptake of drug molecules into cancer cells selectively, and in turn enhances probability of drug-DNA bonding. Moreover, the RF-related loosening of inter-cellular adhesive bonds by retraction of cancer cell cytoplasm, enables homogeneous distribution of the cytotoxic drug throughout the malignant tissue also into deeper, hidden locations.
Synergo local RF and chemotherapy (Thermo chemotherapy) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive
SYNERGO TREATMENT MODALITY & INDICATIONS
Intended Use
The Synergo System is intended for the treatment of intermediate risk, high-risk and very-high risk adult patients
with non-muscle invasive bladder cancer (NMIBC) by providing localized radiofrequency (RF) induced
bladder wall hyperthermia in combination with concurrent intravesical administration of mitomycin C (MMC)
or epirubicin. The device is intended for adjuvant (prophylactic) and neoadjuvant (ablative) treatment and intended
for use by trained healthcare professionals in hospital, clinic, or outpatient healthcare settings.
Intended Users
The Synergo® RITE treatment should be performed by medical personnel (e.g. physician, nurse, medical
technician, etc.) who have undergone training by Medical Enterprises Group in the use of the Synergo® equipment, including practical hands-on training.
Indications
Prophylactic (Adjuvant)
Prevention of tumour recurrence following complete tumour eradication by TURBT.
Indications:
• Status post complete Transurethral Resection of Bladder Tumour (TURBT) no more than 2 months prior to
first treatment.
• Last TURBT specimen should include muscle layer: pathological Stage Ta-T1, papillary or solid, Urothelial
Cell Non Muscle Invasive Bladder Cancer (not single TaLG first episode), pathological Grade LG/HG.
Any finding of CIS whether pure or concomitant to a papillary tumour, should NOT be treated with prophylactic
Synergo® RITE, but rather with the Ablative protocol with reference to CIS treatment.
• Intermediate, high and very high risk patients, according to the European Association of Urology guidelines.
Ablative (Neo-adjuvant)
Eradication of tumour/s:
• By Synergo® RITE alone or
• By a single TURBT/TUF following tumour burden reduction with Synergo® RITE.
Indications:
Patients who may benefit from neoadjuvant therapy are:
- Patients in whom complete tumour eradication cannot be achieved by a single TURBT (multiple sites and/or
high tumour burden).
- Patients presenting with CIS after removal of papillary tumours (if coexisted) and after excluding involvement
of upper tract and/or prostate.
- Patients who are unable to undergo anaesthesia for medical reasons.
- Patients who remain tumour positive following TURBT.
- Difficult to resect tumours due to anatomic location (such as retropubic, bladder neck).
- Clinical decision, such as highly recurrent1 bladder tumours, even when the patient appears to be currently
disease-free.
- Stage, grade, risk group, exclusion criteria and limitations similar to prophylactic indications.
Contraindications
The Synergo® system should not be used in the following cases:
• Tumour stage >T1 (muscle-invasive disease).
• Urothelial cell carcinoma outside the urinary bladder, including the urethra, ureters, kidneys or distant
organs. In order to rule out extra-urinary bladder tumour involvement, CT urography with contrast medium,
intravenous pyelography or ultrasound with good visualization of the upper urinary tract should be
performed no more than six months before the first treatment.
• Any concurrent tumour that requires active or concurrent treatment.
• Urinary bladder diverticulum or diverticula with a cumulative diameter larger than 1 cm.
• Abnormal bladder contour.
• Perforation of the bladder wall.
• Inability to pass an 18 Fr catheter, until the stricture or stenosis has been treated.
• Fistula.
• Bladder volume <150 cc.
• Gross haematuria.
• Contracted bladder.
• Significant residual bladder volume.
• Any known allergy to chemotherapy.
• Patients following partial cystectomy.
• Urethral stricture. Special consideration is required during cystoscopy to verify any existing or developing
urethral stricture before administration of the first treatment session.
• Urinary tract infection.
• Inflammation of the bladder.
• Non-transitional cell carcinoma of the bladder.
• Low blood count.
• Impaired lung, kidney or liver function.
• Any penile prosthesis.
• Pregnancy or breastfeeding.
• Cardiac disease, unless use is authorized by a cardiologist.
• Artificial penile implant.
• Metallic and/or magnetic implants, including pacemakers and prostheses, require special consideration.
For implanted electronic devices intended to regulate cardiac activity, including pacemakers or cardioverter-
defibrillators, refer to the section 2.5. Particular attention is required in patients with metallic prostheses
in the pelvic region.
• Intramural tumours, including tumours located in the ostium.
• Significant urinary incontinence, defined as spontaneous incontinence requiring use of more than one
pad per day.
• History of pelvic irradiation.
• Electronic devices implanted in the abdominal cavity.
• The system is intended for use only with mitomycin C or epirubicin. Safety and effectiveness of use with
other medicinal products have not been established.
Synergo® RITE treatment should not be used in patients with clinical conditions that preclude treatment administration