Supply, commissioning, maintenance and continued support of a Electroporation device for electrochemotherapy (ECT) of cutaneous, sub-cutaneous and deep seated indications for Children's Health Ireland (CHI).

This is a voluntary ex ante transparency (VEAT) notice. This notice acknowledges that Children’s Health Ireland (CHI) proposes to contract with IGEA Clinical Biophysics Ltd for the supply, commissioning, maintenance and continued support of a Electroporation device for electrochemotherapy (ECT) of cutaneous, sub-cutaneous and deep seated indications. Bleomycin Electrosclerotherapy (BEST) is an innovative minimally invasive treatment combining the anti-cancer drug bleomycin with controlled electrical pulses to treat vascular anomalies where other approaches have failed. The electrical pulses temporarily make cell membranes more permeable, allowing the bleomycin to enter abnormal blood vessel cells more effectively. This targeted approach causes the problematic vessels to close and shrink while preserving surrounding healthy tissue. There is no available comparable electrosclerotherapy system which can deliver the required electrical pulses, at the depth required for deep seated indications. CHI at Crumlin have had a Cliniporator Vitae on trial and have successfully treated patients with vascular malformations which have failed other treatments. Before this trial, CHI patients for whom all other lines of therapy had failed had no alternative treatment available to them. Without this technology, these children face a heartbreaking cycle of failed treatments, progressive disfigurement, and the psychological trauma that accompanies visible differences during crucial developmental years. The procedure typically requires fewer sessions than traditional sclerotherapy, dramatically reduces the risk of complications such as skin necrosis or nerve damage, and achieves superior outcomes in the most challenging cases. Children experience significantly less pain and shorter recovery times compared to major surgical procedures, allowing them to return to school, sports, and normal childhood activities within days rather than months. The technique is particularly transformative for treating lesions in cosmetically or functionally critical areas where preserving normal anatomy means preserving a child’s future. To enable the implementation of BEST procedures for treatment of vascular malformations, the paediatric interventional radiology team requires the IGEA Cliniporator Vitae system. There are no technically, clinically, financially, or administratively reasonable or viable alternative or substitute solutions that could be implemented other than the Cliniporator Vitae system.