In March, the Optimizer Smart system from Impulse Dynamics received Breakthrough Device designation. The device is intended to treat individuals suffering from moderate-to-severe Chronic Heart Failure, and for whom treatment with other heart failure devices is not suitable. FDA gave the Optimizer Smart system its Breakthrough Device designation because the device treats a life-threatening or irreversibly debilitating disease, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.
Chronic Heart Failure (CHF), also known as congestive heart failure, occurs when the heart is unable to pump enough blood through the body to ensure a sufficient supply of oxygen. As a result, individuals with CHF may experience breathlessness and exhaustion, as well as swollen ankles and legs. Chronic heart failure is a serious long-term condition that generally gets worse over time, however its progression is very unpredictable and individual prognoses can vary greatly. The causes of CHF are many, and often a number of problems will affect the heart at the same time. A heart’s reduced ability to pump blood can be caused by an inherited genetic defect, an infection, high blood pressure, heart rhythm problems, coronary heart disease, or other diseases that have caused the walls of the heart chambers to become stretched, thickened, or stiff.
Measuring how well someone’s heart is pumping blood can help to diagnose and track heart failure. Physicians will often measure the heart’s ejection fraction, or how much blood the left ventricle pumps out with each contraction. Normally, the ejection fraction will be 50-70%, but if that percentage dips below 50%, a patient may notice they become breathless during activities and are more easily fatigued. In patients with CHF, the ejection fraction percentage can often drop below 40%, with symptoms of heart failure being experienced while performing everyday tasks, and even while at rest.
The Optimizer Smart system was developed to alleviate symptoms in patients for whom other treatments are not suitable or have been shown to be ineffective. There are several different components to the medical device: the Optimizer Implantable Pulse Generator (IPG), the Optimizer Smart Charger system, the OMNI II Programmer System, and the Omni SMART Software. The IPG is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart. After the device is implanted, a physician tests and programs the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability, or ejection fraction. The IPG can be recharged on a weekly basis without any clinical guidance or supervision, and the OMNI II System and Software allow medical personnel to track and then modify the device to meet an individual patient’s needs. The circumstances surrounding each case of CHF are unique, and the software’s ability to tailor the treatment delivered by the device aims to improve the patient’s quality of life.
During two randomized, multi-center clinical trials, a total of 389 patients with moderate-to-severe heart failure received optimal medical therapy, with 191 of those patients also receiving an Optimizer Smart system implant. Patients receiving the implant showed improvements in the distance they were able to walk in physical fitness tests, as well as improvements on standard assessments to measure heart failure symptoms. Patients fitted with the Optimizer Smart system implant reported a decrease in how much CHF symptoms affected their quality of life and how much the symptoms impeded daily physical activities compared to those who received only medical therapy.
Chronic Heart Failure is unfortunately very common, affecting more than 25 million people worldwide, most of them over the age of 65. Drugs or implanted devices, including pacemakers and implantable cardiac defibrillators, are sometimes enough to treat the symptoms associated with heart failure, however these solutions do not always mitigate symptoms. For these patients, there has been little physicians can do to treat their CHF. With the introduction of the Optimizer Smart system, physicians can now offer these patients an implant with the potential to relieve symptoms, prevent a worsening of their condition, reduce time spent in the hospital, and improve the length and quality of their lives…all news that makes our hearts very happy!