News | October 26, 2009

St. Jude Medical Announces European Approval, First Implant of Quadripolar Pacing System

October 20, 2009 – St. Jude Medical Inc. today said it received European CE mark approval for the industry’s first quadripolar pacing system for cardiac resynchronization therapy defibrillators (CRT-Ds).

The quadripolar system offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure. It integrates multiple pacing options and features that enable physicians to better manage common pacing complications without having to surgically reposition the lead.

“Managing heart failure patients is often challenging and typically involves ongoing medical management,” said Klaus Gutleben, M.D., consultant cardiologist at the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany. “This new quadripolar pacing system provides more options for managing the needs of my patients with heart failure and reduces the patient’s risk of needing multiple surgical procedures, which should lead to more efficient patient care.”

The quadripolar system, with the Quartet left ventricular pacing lead, features four pacing electrodes on the left ventricular lead – enabling up to 10 pacing configurations. Multiple pacing configurations provide physicians with more options to pace around scar tissue in the heart and avoid common pacing complications without the need to surgically reposition the lead.

Common pacing complications that can occur in patients implanted with a CRT system include high pacing thresholds and unintentional phrenic nerve or diaphragmatic stimulation. Patients with high pacing thresholds require significantly higher energy to pace the heart; this may reduce the device’s battery life or cause pacing to fail. Phrenic nerve and diaphragmatic stimulation occur when the electrical output from a device inadvertently activates the diaphragm muscle (either directly or via the phrenic nerve), causing hiccups upon each pacing stimulus. Both high pacing thresholds and phrenic nerve or diaphragmatic stimulation are often due to the location of the pacing lead electrode.

“The new features offered in this quadripolar system allow me to mitigate potential complications that would otherwise require an invasive procedure to re-place or reposition the left ventricular lead,” said Dr. Johannes Sperzel of the Kerckhoff Klinik in Bad Nauheim, Germany. “Moreover, the lead maintains excellent handling characteristics, as the additional electrodes do not impact my ability to place the lead in the targeted vein.”

In addition to multiple pacing options, the Quartet pacing lead features other St. Jude Medical technologies such as Optim insulation – a material that combines the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane, to provide increased durability, flexibility and improved handling characteristics – and the “S-curve” design of the QuickFlex lead family, which increases stability.

Cardiac resynchronization therapy, which can be delivered in an implantable cardioverter defibrillator (ICD) or a pacemaker, resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Approximately 23 million people worldwide are afflicted with congestive heart failure (CHF), and 2 million new cases of CHF are diagnosed each year worldwide.

The quadripolar CRT-D and Quartet pacing lead will be distributed via a limited launched in Europe, and will be used in the investigational devices exemption (IDE) trial for U.S. Food and Drug Administration (FDA) approval of the commercialized device, which will be called the Promote Quadra CRT-D.

For more information: www.sjm.com

Related Content

Results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study shows that an investigational set of algorithms in the Medtronic Micra Transcatheter Pacing System (TPS) significantly improves synchrony and cardiac function in patients with atrioventricular (AV) block. This is an impaired electrical conduction between the chambers of the heart.
News | Pacemakers | November 15, 2019
November 15, 2019 — Results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study shows t
Co-principal investigator professor Aydin Babakhani at the UCLA Integrated Sensor Laboratory holds an earlier version of the prototype leadless, wireless amnd batteryless pacemaker. Photo Credit: Cody Duty, Texas Medical Center.

Co-principal investigator professor Aydin Babakhani at the UCLA Integrated Sensor Laboratory holds an earlier version of the prototype leadless, wireless and battery-less pacemaker. Photo Credit: Cody Duty, Texas Medical Center.

News | Pacemakers | November 13, 2019
FDA Warns of Premature Battery Depletion in Some Medtronic Pacemakers
News | Pacemakers | May 07, 2019 | Dave Fornell, Editor
The U.S. Food and Drug Administration (FDA) issued a safety communication to alert healthcare providers and patients...
Artificial Intelligence Can Improve Emergency X-ray Identification of Pacemakers
News | Pacemakers | March 29, 2019
A research team from Imperial College London believes a new software could speed up the diagnosis and treatment of...
Medtronic Recalls Dual Chamber Pacemakers
News | Pacemakers | February 20, 2019
Medtronic is recalling its dual chamber implantable pulse generators (IPGs) due to the possibility of a software error...
CHLA/USC Team Designs Novel Micropacemaker

Model of the human heart with microprocessor located in the pericardial sac and attached to the left ventricle. Graphic courtesy of Business Wire.

News | Pacemakers | June 29, 2018
Investigators at Children's Hospital Los Angeles (CHLA) and the University of Southern California (USC) have...
Permanent Pacing Effective for Older Patients With Syncope and Bifascicular Block
News | Pacemakers | May 24, 2018
Syncope with bifascicular block may be caused by intermittent complete heart block, but competing diagnoses may coexist...
Novel Mechanical Sensor in Medtronic Micra Transcatheter Pacing System Detects Atrial Contractions, Restores AV Synchrony
News | Pacemakers | May 24, 2018
New clinical study results demonstrate that an investigational algorithm, utilizing the accelerometer signal in the...
The Boston Scientific Essentio MRI-safe pacemaker.

The Boston Scientific Essentio MRI-safe pacemaker. It is common for pacemaker patients to need magnetic resonance imaging (MRI), which has not previously been possible because the magnetic fields could damage older devices. All pacemaker vendors now have FDA-cleared MRI compatible pacemakers. 

Feature | Pacemakers | February 13, 2018 | Dave Fornell
There have been several advancements in pac...
Mexican Doctors Safely Reuse Donated Pacemakers After Sterilization

Mexican government reports conclude more than half of the population does not have access to social security or private insurance that covers a pacemaker implant, and 44 percent live in poverty. Recycling donated, explanted pacemakers offers a new option for these patients.

News | Pacemakers | November 10, 2017
Mexican doctors have safely reused donated pacemakers after sterilization, shows a study presented at the 30th Mexican...
Overlay Init