Implantable cardiac contractility modulation delivery device
Optimizer® smart system is a first-of-its-kind, implantable cardiac contractility modulation (CCM) therapy delivery device developed by Impulse Dynamics. It is the first-approved CCM device for the treatment of moderate to severe chronic heart failure in patients, who are at risk despite medical treatment.
The device received a breakthrough device designation from the US Food and Drug Administration (FDA) in 2015. The FDA provided clearance for its clinical use in March 2019. The first patient was implanted with the device at the Ohio State University Wexner Medical Centre in May 2019.
More than 3,500 patients are implanted with the Optimizer smart system, which is available in more than 40 countries, including Europe, China, Hong Kong, Brazil, Australia, New Zealand and India.
The Optimizer smart system comprises an Optimizer smart pulse generator, OMNI II Programmer, and a mini charger.
The rechargeable Optimizer pulse generator is easily implanted into the patient’s heart with two lead configurations. The charge coil and telemetry functions are integrated into the system for flexible positioning of the device into the heart. The device is powered by a Quallion-manufactured Model QL0200I-A lithium-ion battery with 0.2Ah usable capacity.
OMNI II Programmer is a touchscreen tablet or laptop, which features the Optimizer smart programmer application software that connects to a programmer interface. A magnetic induction telemetry wand placed over the implant location establishes communication between the pulse generator and the programmer.
The graphic user interface enables rapid programming, allowing the software to perform a remote operation. The programmer is also equipped with a mini Bluetooth printer, providing access to all crucial device data at once.
The mini charger can charge the device within 40 to 60 minutes, featuring an LED display and a single button to avoid any human error. The charger does not require a power line connection during charging.
CCM™ is an innovative therapy whereby the cardiac muscle of the patient is electrically stimulated during the absolute refractory period. Unlike other implantable systems, such as pacemakers, the CCM therapy modulates the heart muscle strength without affecting the heartbeat or action potential distribution.
The electrical impulses trigger physiological processes in the muscular cells of the heart, which creates an impact on the cellular function at the molecular level and improves heart function. The therapy enhances the physical ability and well-being of the patient.
The device is implanted in the pectoral region on the right side of the patient, at a maximum depth of 4cm and connected to two conventional pacemaker leads positioned on the ventricular septum at a distance of approximately 2cm. The leads are attached to the right ventricle through veins, with one tracking ventricular activity and the other tracking atrial activity of the patients.
The leads deliver electric CCM signals to the right ventricle of the heart at regular intervals throughout the day.
The system has undergone several clinical studies, including randomised controlled studies, whereby it improved six-minute hall walk distance and everyday life of the enrolled patients.
The functional status of the New York Heart Association (NYHA) Class III patients with symptomatic heart failure, despite taking medical treatment was also improved by the delivery of CCM therapy by the Optimizer smart system.
A study demonstrated that 81.5% of the patients receiving CCM therapy with Optimizer smart system experienced improvement in at least one full NYHA functional class.
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