First subcutaneous implant to treat lymphedema. Definitive solution for chronic lymphedema

Información del proyecto

LymphoDrain

Identificador del acuerdo de subvención: 791055

DOI

10.3030/791055

Proyecto cerrado

Fecha de la firma de la CE 29 Noviembre 2017

Fecha de inicio 1 Diciembre 2017

Fecha de finalización 31 Marzo 2018

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

LYMPHATICA MEDTECH SA
Switzerland

Periodic Reporting for period 1 - LymphoDrain (First subcutaneous implant to treat lymphedema. Definitive solution for chronic lymphedema)

Período documentado: 2017-12-01 hasta 2018-03-31

Resumen del contexto y de los objetivos generales del proyecto

Lymphedema (LE) is a chronic disfunction of the lymphatic system affecting more than 14 million people only in Europe and the US. Despite recent advances, LE remains an incurable disease and the standard of care is represented by life-long conservative treatments, which deeply affects patient’s quality of life. Lymphatica has developed a permanent solution for LE: LymphoDrain, able to restore the draining function that will allow patients to regain their normal lifestyle.
The main objective of the project is to meet regulatory requirements and obtain CE-mark in order to start commercialization of LymphoDrain in the European market. To this end, clinical evidence must be obtained which will be achieved through pre-clinical tests and clinical validation and the Quality Management System implemented in accordance with the requirements of the International Standard EN ISO 13485:2016.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

A first prototype of LymphoDrain allowed us to prove the beneficial effect of continuous drainage in a lower hind-limb model of LE in rats. The proof of technology was then obtained with a second prototype of the device, suitable for human use in terms of size and flow rate, which was implanted in the posterior hindlimb of sheep to assess the feasibility of surgical implantation, device tolerability and its functionality upon implantation. The next version of the device has been designed and is currently in production following the outcomes of the clinical risk analysis performed in collaboration with manufacturing partners. The clinical validation roadmap towards CE- marking has been outlined in accordance to the Swissethics protocols and EU Directives.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

Lymphatica has engineered an artificial lymphatic vessel consisting of an implantable micropump/catheter-based drainage system externally controlled with a wearable device. The advantage of LymphoDrain over existing technologies is the definitive replacement of the lymphatic function. The patient will not need any additional treatment and will be able to forget about its disease: no more compression garments, no more physiotherapy, no more aesthetic disability, no more social and psychological distress. This will also result in cost savings for the healthcare and welfare system, replacing chronic treatments with one single intervention and rehabilitating the patient to conduct a normal working life.

SOCIAL AND ECONOMIC BENEFITS OF LYMPHODRAIN

LYMPHODRAIN SYSTEM