Study Will Look Into the Evolution Of AV Conduction Disorders in Pacemaker Patients.
ELA Medical, Inc., a Sorin Group company (MIL:SRN) that specializes in the design and manufacture of implantable pacemakers and defibrillators, announced the first U.S. implant in NATURE, an observational study that will enroll 1,440 patients in North America and Europe.
The objective of the NATURE study is to observe the evolution of atrio-ventricular conduction disorders in pacemaker patients over a 2-year time period. Patients implanted with either ELA Medical / Sorin Group's SYMPHONYTM model 2550 or REPLYTM DR (1) dual chamber pacemakers will be included in the study. Data will be collected using AIDA+TM, ELA's exclusive feature that is capable of identifying different types of atrio-ventricular blocks.
SYMPHONYTM pacemakers are equipped with AAIsafeRTM, a unique algorithm designed to deliver right ventricular pacing only when needed. REPLYTM pacemakers incorporate the same algorithm.
Excessive ventricular pacing has been shown to have harmful effects on the heart, increasing the patient's risk of developing heart failure and atrial fibrillation.
The advantages of an algorithm that reduces unnecessary ventricular pacing, coupled with functions providing a detailed history of the course of heart block should offer a wealth of useful knowledge to physicians implanting pacemakers.
The primary objective of the study will be to measure the incidence (frequency) of high degree heart block in patients with sinus node dysfunction or brady tachy syndrome. Sinus node disease is a disease of the heart's natural pacemaker which causes low intrinsic heart rates. Brady tachy syndrome is defined as an arrhythmia originating in the atrium, the heart's upper chamber, formed by the alternation of various atrial fast rhythms with sinus bradycardia or sino-atrial block.
The first US implant was performed by Dr. Linda Shuck, a cardiologist at Hugh Chatham Memorial Hospital in Elkin, North Carolina. The 70-year-old patient had sinus node dysfunction.
"We hope that the NATURE study will help better identify indications for implant and provide more appropriate pacing modes to pacemaker patients. This study may provide information which will help both physicians and industry towards eliminating deleterious right ventricular pacing in conventional pacemakers," said Dr. Shuck.
"Sorin Group is pleased to start the NATURE study in the U.S. This study reflects the importance that the company puts in the continuous improvement of treatment for pacemaker patients. Because the study of the evolution of AV conduction disorders can best be conducted on large numbers of patients and requires routine data collection, the NATURE observational study is expected to yield valuable findings on AV conduction disorders that may eventually lead to significant changes in the way pacemaker patients are treated", said Dick Ames Senior Vice President, U.S. Cardiac Rhythm Management (CRM), ELA Medical, Inc.
(1) The REPLY pacemaker was released in the European market in May 2007. The device is not available for distribution in the United States. Regulatory clearance of REPLYTM pacemakers in the U.S. is planned in early 2008.
ELA Medical, Inc.
ELA Medical, Inc., part of Sorin Group, is headquartered in Denver, Colorado. The company designs and manufactures implantable pacemakers and ICDs, leads, and Holter equipment and markets them in the U.S.
About the Sorin Group:
The Sorin Group (Bloomberg: SRN.IM; Reuters: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. The Sorin Group includes: Dideco, CarboMedics, Inc., COBE Cardiovascular, Inc., Stöckert, Mitroflow, ELA Medical, Inc., Sorin Biomedica, Bellco and Soludia. It has more than 4,500 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.
For more information, please visit our web site: www.sorin-crm.com or www.sorin.com.
