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.
Recommended White Papers
In December 2020, Impulse Dynamics secured $60m in Series D crossover financing led by CR-CCT Industry Pilot Fund, healthcare investment firm Redmile Group, and Perceptive Advisors, an investment management firm focused on the life sciences industry. The CR-CCT Industry Pilot Fund is co-managed by China Resources Capital Management and China Chengtong (HK). A portion of the proceeds from the funds will be used for the commercialisation of the Optimizer Smart implantable device in the US. The funds will also be used to accelerate the company’s clinical and product development pipelines.
In October 2021, Impulse Dynamics received approval from the FDA to modify the Optimizer Smart medical device’s labelling. The approval allows the company to remove normal sinus rhythm (NSR), which previously served as a barrier to CCM therapy concerned with heart rhythm, from the indications for use statement. The labelling modification substantially increases the number of beneficiaries of CCM therapy.
More than 3,500 patients have been 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.
Optimizer smart system design and features
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 that features the Optimizer smart programmer application software, which is connected to a programmer interface. A magnetic induction telemetry wand is placed over the implant location to establish 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 a light-emitting diode (LED) display and a single button to avoid any human error. The charger does not require a power line connection during charging.
Details of the cardiac contractility modulation therapy
CCM is a novel therapy in which the patient’s cardiac muscle 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 heartbeat or action potential distribution.
The electrical impulses trigger physiological processes in the heart’s muscular cells, which create an impact on the cellular function at the molecular level and improve heart function. The therapy is intended to enhance the patient’s physical ability and wellbeing.
Optimizer smart system implantation procedure
The Optimizer 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 around 2cm. The leads are attached to the right ventricle through veins, with one tracking ventricular activity and the other tracking atrial activity.
The leads deliver electric CCM signals to the heart’s right ventricle at regular intervals throughout the day.
Clinical studies on Optimizer smart system
The Optimizer smart system has undergone several clinical studies, including randomised controlled studies, in which it improved patients’ six-minute hall walk distance and everyday life quality.
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 delivering CCM therapy using Optimizer.
A study demonstrated that 81.5% of patients receiving CCM therapy with Optimizer experienced improvement in at least one full NYHA functional class.
