LUND, Sweden, April 03, 2020, and has simultaneously received an updated EC certificate for the TRANBERG Thermal Therapy System, including the new software. The certificates are issued in accordance with the current Medical Device Directive (MDD) Annex ll and ISO 13485:2016. The certificates are valid until 2023 and 2022 respectively.
"We are very pleased to now have approvals for marketing and sales in place in Europe for the complete TRANBERG system. We will be facing a transition from MDD to the significantly more demanding Medical Device Regulation (MDR). In line with the upcoming requirements, we have updated the "intended use" for the TRANBERG system. The intended use secures that the product is used in a strictly secure way in accordance with EU's regulations and based on clinical data. This means that we continue to work with FLA/LITT as before and adjust imILT to EU's new requirements," says Lars-Erik Eriksson, CEO at CLS.
"For our minimally invasive therapy imILT, the new intended use means that we start a register study. This study fits very well into our plans and becomes a first step in preparing for our randomized clinical study," says Mats Ekelund, Chief Medical Officer at CLS. "A register study means that all hospitals that treat patients using the imILT therapy and the TRANBERG system will take part in the register study and report clinical data in accordance with the study protocol. The main difference between a register study and a randomized study is that the register study has no control group and that the patients are treated in accordance with local routines. The study protocol is therefore less extensive. The register study's primary objective is to catch any side effects and track the system's functions when in regular use, which is exactly the information we want."
With the approval of ThermoGuide, CLS can now offer a complete system for MR-guided laser ablation procedures. The product allows high-precision treatment through improved visualization when placing the treatment fibre. The doctor gets access to real-time monitoring capabilities and can thereby optimize the thermal dose. During treatment with CLS' TRANBERG system, ThermoGuide provides real-time information on temperature development as well as the achieved level of tissue destruction, namely the goal of the treatment. There is huge need for this technology in order to provide additional treatment alternatives for indications such as prostate cancer, brain tumous and epilepsy.
The certificates are available on www.clinicallaser.se
About Clinical Laserthermia Systems
Clinical Laserthermia Systems AB (publ),develops and sells the TRANBERG|Thermal Therapy System including specially designed sterile disposable products for minimally invasive treatment of cancerous tumors, in accordance with regulatory approvals in the EU and in the U.S. The products are marketed for image-guided laser ablation.
This press release has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.
Company Contact Information
Clinical Laserthermia Systems AB:
Lars-Erik Eriksson, CEO
P: +46 70 290 33 00,
E: lee@clinicallaser.se
