ANN ARBOR, Mich. – The University of Michigan Cardiovascular Center is one of the first heart centers in the nation to implant a new cardiac defibrillator that uses a single lead to sense vital changes in heart rhythm.
Single-chamber ICDs are sophisticated electronic devices that use a thin flexible wire, known as a lead, to deliver an electrical shock to the heart when the heart rate becomes dangerously fast.
The Food and Drug Administration granted final approval for the BIOTRONIK Lumax 740 DX System on Monday, and the device was used at the U-M on Tuesday where it provides a new option for gaining important and useful atrial signal information without the risk of implanting multiple leads.
“The ability to detect electrical signals from two cardiac chambers with one lead is a significant advance in ICD technology,” says Frank Pelosi, Jr., M.D., director of the Cardiac Electrophysiology Fellowship program who implanted the first device at the U-M.
“This could assist us to better determine the mechanisms of abnormal cardiac rhythms in our patients and reduce the burden of inappropriate ICD shocks,” he says.
ICDs are very useful in preventing sudden cardiac death in patients with ventricular tachycardia – a fast heart rate – or atrial fibrillation which is a quivering or irregular heartbeat, and about 70,000 people are implanted with them each year.
Traditional standard single-chamber ICDs come with limitations. The devices are designed only to sense changes in ventricular rhythm and are unable to sense atrial arrhythmias, such as atrial fibrillation, correctly. This can result in an increased risk of an inappropriate shock or a stroke if AF is not detected.
The DX System expands the diagnostic capabilities of a standard single-chamber ICD with a single lead, in addition to featuring sophisticated sensors that allow for atrial monitoring and enhanced arrhythmia diagnosis. The system uses an innovative floating atrial dipole. This allows physicians, for the first-time in an ICD, to capture atrial sensing capabilities with one lead.
When combined with the Lumax 740 VR-T DX device the system provides a reliable atrial signal. Additionally, the technology helps discriminate supraventricular tachycardias (SVTs), AF and atrial flutter to reduce the risk of inappropriate shocks.
“The DX System is designed with the patient in mind,” said Paul Woodstock, Executive Vice President of Sales and Marketing at BIOTRONIK, Inc., USA. “Expanding on the benefits of single-chamber ICDs, the DX System provides physicians with atrial sensing and home monitoring capabilities to monitor for important atrial conditions such as AF.”
The DX System also integrates with BIOTRONIK Home Monitoring®, allowing physicians to remotely follow their DX patients’ clinical and device statuses daily—at anytime, anywhere in the world.
The cellular-based system has demonstrated the ability to detect clinically relevant events, including silent, asymptomatic arrhythmias,and device related issues, allowing for earlier medical intervention.
To make an appointment for heart or vascular care, call or email the University of Michigan Cardiovascular Center New Patient Coordination Center at 888-287-1082.
The University of Michigan’s commitment to providing advanced cardiovascular care led to the creation of the University of Michigan Cardiovascular Center. The 5-level facility opened in 2007 and unites the U-M Health System’s cardiovascular services. The Center includes operating rooms, clinics, inpatient beds and indoor and outdoor healing gardens. The U-M is the top ranked heart and heart surgery program among Michigan hospitals. To learn more visit www.uofmhealth.org/heart.