News | March 30, 2009

Long-Term Data Demonstrates Safety, Efficacy of OPTIMIZER System

March 30, 2009 - Impulse Dynamics announced findings from the FIX-HF-5 study of its OPTIMIZER System at the 58th Annual Scientific Session of the American College of Cardiology in Orlando, FL, demonstrating positive longer term effects of the system’s cardiac contractility modulation (CCM) signals.

The OPTIMIZER System consists of a pulse generator and conventional pacing leads which deliver the therapy to the cardiac tissue. The device is implanted in a manner similar to a pacemaker procedure. Unlike conventional pacing methods, however, the OPTIMIZER device utilizes CCM therapy in which electrical impulses are delivered to the heart after the heart has already initiated its contraction. CCM is designed to increase the forcefulness of the heart's pumping action rather than initiating a new contraction.

The FIX-HF-5 study met its primary safety endpoint, which was a non-inferiority demonstration of the composite of all-cause mortality and all-cause hospitalizations. Compared to the control group, patients treated with CCM signals over the other group had significantly improved exercise tolerance as judged by an increase in peak oxygen update (p=0.02) and an improvement in quality of life as judged by a reduction in the Minnesota Living with Heart Failure score (p

"We are pleased to report these longer term data that add to the growing wealth of knowledge showing the potential of CCM as a therapy for heart failure patients with no other options," said Dr. William Abraham, professor of internal medicine and director of the Division of Cardiovascular Medicine, Ohio State University Medical Center.

In a subgroup representing the "less sick" half of the study population (NYHA Class III with ejection fraction 25% and above), the study found even greater improvements not only in peak VO2 (p=0.001) and quality of life (p=0.003), but also in the primary endpoint of ventilatory anaerobic threshold (p=0.03). These effects were largely maintained at twelve months as well.

"This subgroup of the less severely impaired patients appeared to demonstrate an overall greater response rate that those in the control group," noted Dr. Alan Kadish, professor, Division of Cardiology, Feinberg School of Medicine, Northwestern University. "We are particularly encouraged by the findings in this subgroup of patients and look forward to focusing on this subgroup in our next study."

The OPTIMIZER System is CE Marked and commercially available in Europe and is currently under clinical investigation at major U.S. research and academic facilities.

For more information: www.impulse-dynamics.com.

Related Content

Societies Publish New Guidance for Treatment of Slow, Irregular Heartbeats
News | EP Lab | November 09, 2018
The American College of Cardiology (ACC), the American Heart Association (AHA) and the Heart Rhythm Society (HRS)...
A view of the EPD Solutions catheter ablation system image guidance. It displays the catheter within a pre-acquired 3D segmented CT image. The D700 system provides a real-time lesion assessment tool that predicts transmurality and permanency of lesions, pre- and immediately post-ablation.

A view of the EPD Solutions catheter ablation system image guidance. It displays the catheter within a pre-acquired 3D segmented CT image. The D700 system provides a real-time lesion assessment tool that predicts transmurality and permanency of lesions, pre- and immediately post-ablation.

News | EP Lab | June 05, 2018
June 5, 2018 — Philips Healthcare has signed an agreement to acquire EPD Solutions, a provider of image-guidance in c
A recent study shows the Baylis NRG radiofrequency (RF) Transseptal puncture catheter has a lower incidence of embolism in EP cases.
News | EP Lab | May 21, 2018
May 21, 2018 — A recent study published in Heart and Vessels has found that the use of the Baylis Medical NR
Myocarditis is an Under-recognized Etiology of Symptomatic Premature Ventricular Arrhythmia (PVCs). #HRS #HRS2018
News | EP Lab | May 18, 2018
May 18, 2018 — A significant number of patients with symptomatic premature ventricular contractions (PVCs) have under
Novel Antibiotics Can Help Lower EP Device Infection Rates. Pictured here is an ICD. Implantation of pacemakers, ICDs and the related cardiac leads opens patients to infection risk.

Implantation of pacemakers, ICDs and the related cardiac leads opens patients to infection risk.

News | EP Lab | May 17, 2018
May 10, 2018 – A new study is the first to test the clinical effectiveness of incremental peri-operative antibiotics
The Apple Watch Series 2, Samsung Galaxy Gear S3 and the Fitbit Charge 2 were all able to properly diagnose the very rapid heart beats involved in  paroxysmal supraventricular tachycardia (PSVT). #HRS2018

The Apple Watch Series 2, Samsung Galaxy Gear S3 and the Fitbit Charge 2 were all able to properly diagnose the very rapid heart beats involved in  paroxysmal supraventricular tachycardia (PSVT).  

News | EP Lab | May 16, 2018
May 16, 2018 — A new study is the first to validate the accuracy of wrist-worn wearable devices in measuring induced
LivaNova Completes Sale of Cardiac Rhythm Management (CRM - electrophysiology) Business to MicroPort Scientific
News | EP Lab | April 30, 2018
April 30, 2018 — LivaNova announced it completed the sale of its cardiac rhythm management (CRM) business to MicroPor
LivaNova Enters Binding Letter of Intent to Sell Cardiac Rhythm Management Business
News | EP Lab | January 26, 2018
January 26, 2018 — LivaNova PLC and MicroPort Scientific Corp.
Societies Detail Treatment for Patients With Ventricular Arrhythmias
News | EP Lab | October 30, 2017
The American College of Cardiology, along with the American Heart Association and the Heart Rhythm Society, published...
Overlay Init