The Implantable Subcutaneous String Defibrillator (ISSD), an innovative subcutaneous cardioverter defibrillator for a new paradigm in cardiac rhythm management.

Informations projet

ISSD

N° de convention de subvention: 823081

DOI

10.3030/823081

Projet clôturé

Date de signature de la CE 20 Juin 2018

Date de début 1 Juillet 2018

Date de fin 31 Mars 2021

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 3 519 750,00

Contribution de l’UE

€ 2 463 825,00

Coordonné par

NEWPACE LTD
Israel

Periodic Reporting for period 3 - ISSD (The Implantable Subcutaneous String Defibrillator (ISSD), an innovative subcutaneous cardioverter defibrillator for a new paradigm in cardiac rhythm management.)

Période du rapport: 2020-06-01 au 2021-03-31

Résumé du contexte et des objectifs généraux du projet

Sudden Cardiac Arrest (SCA) is a life-threatening heart condition and one of the most common causes of death in developed countries. It claims more than 350,000 lives per annum in Europe1 and about 95% of people who have SCA die before they reach the hospital. Ventricular Fibrillation is the major cause of SCA and the only effective treatment for it is to prompt electrical defibrillation. There are currently two different implantable technologies to prevent SCAs: 1) Transvenous Implantable Cardioverter-Defibrillators (TV-ICDs), which are implanted under the skin with leads that snake through veins into the heart and are attached to the heart ventricles or atria; and 2) Subcutaneous Implantable Cardioverter-Defibrillators (S-ICD), which also have generators and leads but avoiding leads within the heart, being implanted subcutaneously in whole with no leads within the heart. However, each of these technologies are mired with problems including patient discomfort and as in the case of the S-ICD, a big surgical pocket at implant, and negative impact due to the ICD relatively large generator´s size, the need to replace their batteries every 5-7 years which requires a new replacement operation as well as use of intensive fluoroscopy with occasional lead extractions. NewPace has developed the Implantable Subcutaneous String Defibrillator (ISSD), to address the need for better patient outcomes due to SCA, providing more reliable and safe cardiac rhythm management. The overall objectives of the project are to complete development of the ISSD device, undertaking a series of preclinical tests to confirm its safety and effectiveness, and eventually validating it through a clinical trial with European medical centres. Completion of these objectives will result in a product that is ready for the market.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

NewPace has been focused on finalising the ISSD design and internal testing, before performing the verification & validation testing. In additon to advancing the product's market readiness NewPace has engaged in a number of business development activties that has included participating in events worldwide to engage stakeholders and maintain its IP management strategy that has involved the filing of new patents during the 1st reporting period.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

The ISSD will provide the following key benefits: (1) Subcutaneous: implanted subcutaneously with no leads within the heart; (2) Unitary and flexible: totally integrated (no can, nor leads) and flexible string shape device; (3) Rechargeable: requires one hour/once in a year wireless recharge, designed for 10 years before replacement; (4) Smart phone connectivity: low energy Bluetooth communication (BLE) providing remote monitoring functionalities using a simple smart phone app.

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