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

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A less invasive approach to treating sudden cardiac arrest

A new leadless implantable cardioverter defibrillator that can be remotely recharged aims to set a new standard of care for treating sudden cardiac arrest.

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Sudden cardiac arrest (SCA), a life-threatening emergency that occurs when the heart suddenly stops beating, is a leading cause of death throughout the developed world. As its name suggests, SCA happens suddenly and with little warning. As a result, out of the nearly 350 000 European lives that SCA claims every year, 95 % die before they reach the hospital. The only accepted method for treating SCA is through electrical defibrillation – a therapy that delivers a high-voltage, high-energy electric pulse to the heart. Although external defibrillator units are available, they’re only effective when an SCA incident happens to occur near one. For patients who are at high risk of SCA (such as post-heart attack patients with low heart functionality), the ‘gold standard’ of care is the use of an implantable cardioverter defibrillator (ICD). Currently, there are two types of ICD devices on the market: transvenous ICD (TV-ICD) and subcutaneous ICD (S-ICD). Although effective, both devices have their fair share of problems, including the use of leads within the heart (for TV-ICD), patient discomfort, the need for surgery, and the fact that the device must be replaced every 5 to 7 years due to battery depletion. But now there’s a third option. With the support of the EU’s ISSD project, the Israeli medical device manufacturer NewPace has developed an Implantable Subcutaneous String Defibrillator (ISSD). “Unlike other ICDs, the ISSD is leadless, flexible, and can be wirelessly recharged for extended durability,” says Avi Broder, co-founder, CFO and VP of business development at NewPace. “Because our device doesn’t require any leads to be placed directly in the heart, it can be easily implanted via a minimally invasive outpatient procedure.” With the support of EU funding, the ISSD device is one step closer to market readiness.

A step change in medical technology

According to Broder, the ISSD represents the next generation in subcutaneous cardioverter defibrillators. “With leads placed alongside the sternum and the side, the device is easily inserted below the ribs, with only two small incisions required and no need to create a pulse generator pocket,” he explains. “This results in minimal anatomical protrusion, improved patient comfort, and a good aesthetic appearance.” The ISSD also represents a step change in medical technology. For example, in addition to being the world’s first rechargeable ICD, the device uses Bluetooth communication for easy monitoring and interaction with other implanted devices. “This function means care providers can remotely monitor a patient using a simple smartphone app,” adds Broder. Despite some delays due to the COVID-19 pandemic and scarce financing, Broder says that the EU funding has allowed NewPace to advance its ISSD device towards the clinical trial stage. “We have nearly completed the development of the device and have now shifted into the manufacturing, testing and validation stages,” he explains. “This will then be followed by clinical trials, with the aim of gaining EU regulatory approval.”

Ready to save lives

Thanks to the support of EU funding, NewPace is well on its way to developing an implantable and autonomous therapeutic device that could save millions of lives. “There are only a handful of companies developing implantable, life-saving defibrillators, and we are proud to be one of them,” concludes Broder. As the company works towards regulatory approval and commercialisation, it is also seeking to raise additional financing.

Keywords

ISSD, hospital, sudden cardiac arrest, SCA, electrical defibrillation, implantable cardioverter defibrillator, ICD, subcutaneous cardioverter defibrillator, medical technology

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