A ground-breaking new wireless pacemaker technology, which could benefit the world’s 1.5m heart failure patients, has received European CE Mark approval.
The company responsible for the innovative wireless pacemaker, EBR Systems, has received CE marking approval for its WiSE (Wireless Stimulation Endocardially) Technology.
WiSE Technology is reportedly the world’s first and only wireless endocardial (inside the heart) pacing system for cardiac resynchronization therapy (CRT).
CRT is a treatment for heart failure that uses an implantable pacemaker to improve the heart’s pumping efficiency by synchronizing the left and right ventricles. Studies have shown that CRT treatment reduces heart failure symptoms, hospitalizations and mortality.
Wireless pacemaker receives approvals in EU and US
CE Mark approval of its WiSE System gives EBR Systems the ability to train and educate physicians in the European Union on the use of the new wireless pacemaker technology, which will enable more patients to benefit from the innovative therapy.
The European CE Mark approval came one month after EBR Systems was granted an Investigational Device Exemption (IDE) by the US Food and Drug Administration for its WiSE technology, which allows the device to be used in a US clinical study to establish safety and effectiveness.
To help develop the world’s first wireless pacing system, Silicon Valley start-up company, EBR Systems, collaborated with Cambridge Consultants, with their deep knowledge of integrated circuit design helping EBR define the system architecture which could be realised with modern silicon chip technology.
Emulation used to speed up time to market for wireless pacemaker
In helping to develop the WiSE technology, Cambridge Consultants created a full system hardware emulator of the final Application-Specific Integrated Circuits (ASIC), which form the core of the Wireless Cardiac Stimulation system. This meant that the other system elements and the software could be designed and tested over a year before a physical ASIC prototype was available.
This approach dramatically reduced the overall time of the development and enabled EBR to ensure that the WiCS system would work as envisaged before committing to the costly and time-consuming manufacture of the product.
EBR Systems develops devices for cardiac rhythm management and were founded by Silicon Valley medical technology investor Allan Will.
EBR System’s WiSE Technology is a system which Will said would change the way we treat the world’s heart failure patients: “The WiCS system represents a huge breakthrough in pacemaker technology, not only in how we treat chronic heart failure patients today, but in eliminating leads and enabling site selected pacing locations in the heart for a wide variety of cardiac pacing applications/
“Many of the complications and reliability failures of pacemaker systems are attributed to leads, by eliminating leads we can address the problems which come with them, and advance cardiac pacing therapy for all patients.”
This elimination of leads is one of the major benefits of the new WiCS system, with conventional CRT devices having to use wired leads to deliver pacing pulses to the left ventricle of the heart. These wires can either break or fail which lead to complications in about 5%-10% of cases. EBR Systems’ WiSE technology is wireless, which completely eliminates the need for a pacing wire in the left ventricle.
In addition to the benefit of not using wires, 30% of patients receiving conventional CRT do not respond to the therapy, with the major cause attributed to the inconsistency of results achieved using wire leads to transmit racing pulses to the left ventricle’s exterior surface. The WiSE technology also eliminates the risk of clots, heart attacks or stroke which can be caused by wire leads being placed inside the left ventricle.
This innovative technology eliminates the need for a left ventricular lead and is designed to let the physician place the stimulation point at an optimal and patient specific location inside the left ventricle, with endocardial stimulation generally considered more like the natural activation pattern of the heart than conventional CRT devices.
As well as providing improved help for the world’s heart failure patient’s, the new WiSE technology also helps address the financial issue that more than $1bn out of $3.5bn spent annually on CRT devices provides no patient benefit.
Eliminating pacing leads in the left side of the heart is a major breakthrough in pacemaker design and could see CRT System’s new technology become the standard for treating heart failure patients.