News | August 10, 2008

Sorin Gets FDA Approval For World’s Smallest Implantable Dual Chamber Pacemaker

August 11, 2008 - The Sorin Group said last week the FDA approved the REPLY family of dual and single chamber pacemakers, with the world’s smallest dual chamber pacemaker at 8cc’s.

The company said the device is designed to reduce ventricular pacing and promote natural cardiac function. REPLY integrates Sorin Group’s new proprietary SafeR pacing mode. The technology builds on the Sorin Group’s AAISafeR pacing mode first introduced in Europe in September 2003 and in the U.S. in May 2005. AAISafeR switches from AAI to DDD in case of AV block detection, and has been shown to reduce unnecessary pacing in both sinus node disease and unselected AV block patients. The company said delivering unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation2.

In addition to SafeR, the REPLY pacemaker delivers automatic features such as SmartCheck, which lets the user automate follow up tests and provides comprehensive data reporting and recommendations.

Dr. Randy Lieberman, director of electrophysiology at Harper University Hospital and assistant professor of medicine at Wayne State University School of Medicine in Detroit, implanted the first Reply pacemaker in the U.S.

“The updated 2008 ACC/AHA Guidelines for Device-Based Therapy highlight the new standard of care in pacing, which is to minimize unnecessary ventricular pacing,” Dr. Lieberman said. “The Reply pacemaker was the right choice for this patient. Pacemaker options that only offer AV delay or AV search hysteresis do not eliminate frequent ventricular pacing for a significant number of patients. It’s important to know that down-sized devices do not mean that physicians have to compromise. Reply provides the output, longevity and pacing algorithms that physicians are looking for in a pacemaker.”

The REPLY pacemaker will be distributed in the U.S. by ELA Medical Inc., a Sorin Group Company.

For more information: www.sorin.com

Related Content

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 pacemaker technologies over the past few years.
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...
Pacemakers and Other Cardiac Devices Can Help Solve Forensic Cases
News | Pacemakers | June 20, 2017
Pacemakers and other cardiac devices can help solve forensic cases, according to a study presented at the European...
Videos | Pacemakers | May 23, 2017
Vivek Reddy, M.D., director of cardiac arrhythmia services and professor of medicine, cardiology, Mount Sinai Hospita
micra leadless pacemaker
Feature | Pacemakers | May 16, 2017
May 16, 2017 - The preliminary results for the Medtronic Micra Transcatheter Pacing System (TPS) Post-Approval Regist
Videos | Pacemakers | May 16, 2017
This video, provided by Medtronic, demonstrates the implantation of Micra transcatheter pacing system (TPS).
closed loop stimulation, DDD-CLS, ACC17, SPAIN trial
Feature | Pacemakers | March 22, 2017
March 22, 2017 — Patients with recurrent fainting episodes (syncope) who received a pacemaker delivering a pacing pro
Overlay Init