Wireless at heart
The world’s first wireless cardiac pacing system for heart failure is about to land in Europe after achieving CE Mark approval. The technology, known as WiSE (Wireless Stimulation Endocardially) and developed by EBR Systems, represents a real breakthrough in heart failure treatment and could benefit globally 1.5 million patients.
No wire, results get higher
Cardiac resynchronisation therapy (CRT) devices – the common designation would name them pacemakers – usually operate with wires in order to deliver pace pulses to the left ventricle of its carrier. Unfortunately, this traditional approach is far from perfect and can go together with complications for up to 10% of CRT users. Not to mention the fact that about 30% of heart failure patients don’t respond to conventional cardiac resynchronisation therapy – which actually corresponds to $1 billion out of the $3.5 spent annually on CRT devices. For this reason, EBR Systems worked with Cambridge Consultants, an affiliate of Altran, in order to develop WiSE, the only wireless endocardial pacing system for cardiac resynchronisation therapy.
Safe and (ultra)sound
How does this advanced and innovative device work ? On one hand, a small transmitter located between two ribs. On the other hand, a tiny electrode implanted in the left ventricle. The first watches for a pacing event from a traditional pacemaker in the right ventricle and then sends a synchronised ultrasound signal to the second. Then, these sound waves end up converted to energy that provides proper cardiac pacing. In addition, the WiSE technology offers to the doctor the possibility of placing the pacemaker stimulation point where it could be the most effective for each patient. An innovative system that could matter in the future, given that studies have demonstrated that cardiac resynchronisation therapy succesfully implemented reduces heart failure symptoms, hospitalisation as well as mortality.
An 81% improvement after first trials for the patients
« Power consumption, size and safety are critical when it comes to pacemaker technology »
Simon Karger, Head of surgical and interventional products at Cambridge Consultants
“Power consumption, size and safety are critical when it comes to pacemaker technology so we faced a complex challenge” explained Simon Karger, head of surgical and interventional products at Cambridge Consultants. On account of this, an array of trials has been run this year in the the European Union. In total, 97% of 35 patients that had a failed attempt using the conventional CRT approach were implanted successfully with the WiSE technology. According to primary results, 26 of them passed the first mark after six months, improving their clinical composite score in 81% of the patients – a measure of symptom improvement. These are very promising prospects for the technology and the patients. With this CE mark approval obtained, EBR Systems expects to continue to work with leading European clinicians for the next 12 months with the aim of providing benefits to more heart failure patients.