SENNEX Toumor thrapy
Our approvalis based on research studies according to the European Directive Meddev 2.7.1 (evaluation of clinical data). According to Directive 93/42/EEC and the MPG (Medicinal Decices Act), the suitability of a medicinal device for its intended purpose has to be verified by clinical evaluation under consideration of the specified performance characteristics and risks. An assessment of possible undesired side effects has to be carried out in addition. In the course of a clinical evaluation based on the results of a clinical study, MEDDEV 2.7.1 stipulates that all relevant documents that are required in accordance with DIN EN ISO 14155 (clinical investigation of medical devices for human subjects) are to be consulted.
BionMed Technologies Gmbh (Member of the OnMed AB Group, Sweden, since 2013) have been successfully developing, manufacturing and marketing innovative medical products since 1995. Our current focus is the SENNEX system for use in oncological therapy. In addition to our commitment and innovative strength, the high demands we put on your quality management according to DIN ISO 13485 and to the service to our customers are the pillars of our success.
SENNEX® Electrochemotherapy is a therapeutic procedure for treating cutaneous tumours via electroporation using certified electrodes. The electroporation process is combined with local chemotherapy.
1. To begin electrochemotherapeutical treatment using SENNEX®, a cytotoxic drug is applied around the tumour cell.
2. Then the electrodes are placed around the tumour. Eight extremely short electric pulses are delivered into the cell. It is essential that the electric field completely surrounds the tumour.
3. Pulses of precisely calculated voltage and duration open up small pores in the cell wall through which the active substances can diffuse into the cell. After a short while, the pores close again.
4. When the pores are closed again, the cytotoxic agents can unfold their effect with increased intensity and destroy the tumour cell.
Each session has a duration of about 30 minutes and is performed using either local anaesthesia or, depending on the scope of the application, general anaesthesia.
The treated area is expertly covered. To avoid infection, dressings should be changed regularly. This should be done by a doctor. Possible incidence of infection can require antibiotic therapy.
Electrochemotherapy is a highly effective form of treatment that can trigger concomitant effects. For example: a temporary sensation of heat or the occurrence of pigment changes in the treated area are possible.
During treatment, the treated area is anaesthesised and thus insensitive to pain. However, subsequent occurrence of pain cannot be entirely ruled out, since, after all, this is an – albeit small – surgical intervention. Depending on the patient’s sensitivity to pain, prescription of painkillers for a limited period of time may be necessary.
Cases of nausea after application of ECT have also been reported; such cases require diagnosis and appropriate treatment by the attending physician, since nausea can have different causes in different patients.
In rare cases, allergic reactions to the chemotherapeutic agent applied have been reported. Similarly, the occurrence of pulmonary fibrosis resulting in shortness of breath cannot be ruled out. Should your doctor expect such a reaction in your case, he will perform the appropriate tests and act accordingly.