Unlike traditional cardiac defibrillation implants that place wires directly on the heart, Boston Scientific’s (NYSE:BSX) under-the-skin implant promises to be less invasive while proving a "great asset" to patients, according to a study published in the American Heart Assn. journal Circulation.
The new device was shown to successfully restore normal heart rhythm without ever physically touching the heart, researchers reported, but the device also unnecessarily shocked 13% of study participants.
Patients at high risk of sudden cardiac arrest are often implanted with traditional implantable defibrillators, which thread electrical wiring into the heart’s nearby blood vessels to provide an immediate and life-saving shock to the heart. The new Boston Scientific implant, called a subcutaneous implantable cardiac defibrillator, or S-ICD, uses a lead that is placed under the skin on the left side of the sternum.
"This new system was developed over a dozen years to combine some of the best aspects of traditional implantable cardiac defibrillators and external defibrillators," Martin Burke, the study’s lead author, said in prepared remarks.
Study authors evaluated 330 patients, all implanted with S-ICD, for 11 months. During that time, 38 experienced heart irregularity that was successfully restored to a normal rhythm because of the device, but 41 patients felt electrical shocks that were not prompted by any cardiac events.
When the device was tested by inducing an abnormal heart rhythm, S-ICD responded and reversed the abnormality 100% of the time, besting the FDA goal of an 88% response rate, researchers said. However, some cardiologists say the tests have troubling limitations, according to MedPageToday.
The S-ICD can be implanted without an x-ray and reduces the risk of damaging blood vessels near the heart, according to the study. Another trial comparing traditional devices to the S-ICD is currently underway.