BIOTRONIK Announces First U.S. Implantation Of A Biventricular Pacemaker For The AVAIL CLS/CRT Clinical Study
Study Promises to Demonstrate Efficacy of Highly Sophisticated Biventricular Pacemaker and Clinical Benefit of Closed Loop Stimulation (CLS) Rate-Adaptive Therapy for Improved Quality of Life in CHF Patients with Permanent Atrial Fibrillation
Lake Oswego, OR -- On Thursday, December 9, at the Heart and Vascular Center in Lake Charles, LA, electrophysiologist Dr. William Bailey implanted a Protos DR/CLS pacemaker in a biventricular (BiV) configuration in a 72-year-old male with a history of Class III congestive heart failure (CHF) and permanent atrial fibrillation. The Protos DR/CLS, manufactured and legally marketed by BIOTRONIK, Inc., offers the unique Closed Loop Stimulation (CLS) method of rate-adaptive pacing therapy.
This device is the first implant for a randomized three-arm clinical investigation designed to demonstrate efficacy of both the Stratos LV and the Protos DR/CLS pacemakers in CHF patients who have undergone AV nodal ablation (Ablate and Pace) for persistent or permanent symptomatic atrial fibrillation with poorly controlled rapid ventricular heart rates.
The Stratos LV received CE mark in Europe in August, 2002, and the Protos DR/CLS received FDA approval for conventional pacing indications in December, 2002. The AVAIL CLS/CRT study was designed by a prominent steering committee composed of eleven academic and private electrophysiologists from throughout the U.S. BIOTRONIK, Inc. is the sponsor of the AVAIL CLS/CRT study under an investigational device exemption (IDE) granted by the FDA.
The AVAIL CLS/CRT study is designed to randomize patients into three groups: Stratos LV biventricular implants, Protos DR/CLS biventricular implants, and Stratos LV pacing in a standard right ventricular configuration as the control group. The primary endpoint for the study is to demonstrate the clinical benefit of biventricular pacing for the NYHA Class II and Class III heart failure population who also have permanent atrial fibrillation and have undergone AV nodal ablation. The results will be compared to the traditional right ventricular pacing study arm. A secondary endpoint is to show the clinical benefit of BIOTRONIK's proprietary Closed Loop Stimulation rate-adaptive therapy in the same patient population.
The AVAIL CLS/CRT study is unique in that it not only evaluates the benefits and improvements in quality of life with an advanced BiV pacemaker (Stratos LV), but also promises to demonstrate the advantages of physiologic rate-adaptive pacing utilizing a modified configuration of a conventional pacemaker (Protos DR/CLS). The results of this study are expected to provide the medical community with a broader range of choices when it comes to device selection, particularly since atrial fibrillation co-existing with CHF can be difficult to manage.
"As a physician, watching my patients feel better is extremely rewarding; biventricular pacing achieves just that for many patients with CHF. Indications for this exciting new therapy are constantly expanding. I am confident that biventricular pacing will also improve the well-being of patients with poorly controlled atrial fibrillation. The unique CLS method of rate-adaptive pacing developed by BIOTRONIK is expected to provide promising benefits. The AVAIL study has a great potential to further expand the horizons of biventricular pacing," states Dr. Michael Orlov, the principal investigator for the AVAIL CLS/CRT study.
BIOTRONIK plans to enroll approximately 300 patients at 30 U.S. centers under this clinical trial.
BIOTRONIK's U.S. headquarters are located near Portland, Oregon. Founded in 1963, BIOTRONIK today ranks as one of the leading cardiac rhythm management companies, conducting business in over 100 countries worldwide, and providing a full range of innovative cardiovascular products of the highest quality and reliability. BIOTRONIK's motto "Technology Helping to Heal," is reflected in the company's primary guiding principle: helping patients by researching, developing, and marketing biomedical products to restore, secure, and enhance their quality of life.
Source: BIOTRONIK, Inc.