First Pacemaker Patient Enrolls in the NATURE Study


August 14, 2007

August 14, 2007 - ELA Medical Inc., a Sorin Group company 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 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 SYMPHONY model 2550 or REPLY DR (1) dual chamber pacemakers will be included in the study. Data will be collected using AIDA , a feature that is designed to identify different types of atrio-ventricular blocks.

The primary objective of the study will be to measure the incidence of high degree heart block in patients with sinus node dysfunction or brady tachy syndrome, a disease of the heart’s natural pacemaker, which causes low intrinsic heart rates. Dr. Linda Shuck, a cardiologist at Hugh Chatham Memorial Hospital in Elkin, North Carolina, performed the first U.S. implant in a 70-year-old patient that 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.

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