EMBLEM™ S-ICD System

Sudden Cardiac Arrest (SCA)

SCA is a serious, life-threatening medical emergency that happens abruptly and without warning. During SCA, the heart’s electrical system malfunctions, and it is no longer able to pump blood to the rest of the body. The lack of blood to the brain causes the person to lose consciousness quickly. If the person does not receive immediate treatment with defibrillation, brain damage and death can occur.

For those at risk of SCA, one treatment option is a pacemaker-like device called an implantable cardioverter defibrillator (ICD), which may prevent sudden cardiac death.2 ICD therapy has been shown to effectively stop 95 percent or more of dangerously fast heart rhythms. With an ICD device, 19 out of 20 people will survive SCA.

EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System

EMBLEM

The EMBLEM S-ICD System is an innovative and truly novel ICD. Unlike traditional ICDs that require placement of at least one lead in or on the heart, the S-ICD System is implanted just under the skin and provides the patient protection from SCA without invading the heart and blood vessels. Leads in the heart may be associated with infrequent but serious complications, including lead displacement, fracture and systemic blood infections, or the need for lead extraction, which may lead to hospital readmission, increased mortality and associated costs. It is the only fully subcutaneous (under the skin) ICD available.

The EMBLEM S-ICD System is 20 percent thinner and is projected to last 40 percent longer than the previous S-ICD System. These improvements may further improve patient comfort and cosmetic outcomes while reducing the number of times the device will require replacement. The EMBLEM S-ICD System is also enabled for remote patient management for increased patient convenience.

S-ICD vs. Pacemaker

Both devices are implanted in people and both use electrical impulses to stimulate the heart, but there are differences:

  • A pacemaker helps control an abnormally slow heart rhythm by sending small electrical pulses to the heart if it is beating too slowly.
  • An ICD device, such as the S-ICD System, sends an electric shock to the heart if it detects a dangerously fast heartbeat in order to restore the heart to its normal rhythm. It is designed to prevent SCA.

How the S-ICD System Works

Like other ICDs, the S-ICD System continuously monitors a patient’s heart rhythm, 24 hours a day. If the S-ICD System detects a heart arrhythmia (abnormal rhythm) problem, it sends out an electrical shock to correct it.

The experience of receiving a shock can differ for each person. Because many patients faint or become unconscious shortly after a very fast heart rhythm starts, they do not feel these high-energy shocks. Those who are conscious sometimes describe the shock as a “kick in the chest.” The sensation lasts for only a second. If shock is felt, a patient should notify their physician immediately.

How S-ICD is Different from a Traditional ICD

ICD therapy is a trustworthy therapy that has prolonged thousands of lives. When ICD devices were first introduced in the 1980s, they were implanted in the abdomen. Later came the transvenous ICD, which is implanted in the shoulder area. The less invasive S-ICD System is the newest type of ICD device, which delivers protection without touching the heart.

Transvenous ICD

  • Typically implanted in the left shoulder area, near the collarbone.
  • Using X-ray imaging, the leads are fed through a vein into the heart and across the heart valve.
  • Depending on the patient’s heart condition, 1 or 2 leads will be placed in the heart, and then they are attached to the heart wall for optimal connectivity.

S-ICD System

  • Typically implanted on the left side of the chest next to the rib cage, with the lead implanted just under the skin above the breastbone.
  • The electrode is placed under the skin, and delivers therapy without wires implanted in the heart.
  • S-ICD leaves the heart and blood vessels untouched and intact.

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