A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Sorin

Active implantable medical devices by Sorin

Sorin Announces CE Mark and Implant of its MRI-Compatible Kora 100 Pacemaker with Automatic MRI Mode

Posted on by Posted in Bradycardia, Cardiac Pacing, MRI-safe, Sorin

Sorin Kora 100 MRI pacemaker David Prutchi PhD www.implantable-device.com

Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system.

According to the press release:

KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population is prone to other medical conditions such as arthritis, cancer or stroke that may require MRI examinations for optimal diagnosis and management.

The KORA 100 pacing system has been designed with both patients and physicians in mind. Device settings which allow safe operation during an MRI examination are automatically enabled when KORA 100 pacemakers detect the scanner’s magnetic field. Similarly the devices sense when a patient leaves the MRI field, and return to normal operation within five minutes. The Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, limits the amount of time that KORA 100 pacemakers operate in MRI mode.

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Enopace Receives Additional $5M Investment for Development of Stimulator for Treatment of Heart Failure

Posted on by Posted in Aortic Stimulation, Enopace Biomedical, Heart Failure (CHF), Sorin, Yossi Gross (Rainbow Medical)
Enopace's implantable device

From Patent Application Publication: US 2011/0137370 A1

Sorin recently announced a $5 million investment in Israeli startup Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure.  Back in October 2011 Sorin invested $7 million to finance the initial clinical studies of Enopace’s technology as well as ongoing product development.

Very scant details are available besides that it is developing a neuromodulation system to treat patients with congestive heart failure. According to the company, its technology consists of a minimally invasive, implantable neurostimulation device that increases cardiac efficiency by reducing left ventricular workload.

From Enopace’s patent applications, it seems that Enopace’s device consists of a stimulation unit that is placed within the aorta close to the heart, and which is driven wirelessly from a coil that is placed within a vein closeby to the artery. The transmitting coil is in turn driven from an implanted control unit that is implanted subcutaneously.

Israeli business news website “Globes” interviewed Enopace’s CEO Amir Dagan, and reported in February 2013:

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Sorin Launches Reply 200 Pacemakers with Sleep Apnea Monitoring

Posted on by Posted in Bradycardia, Cardiac Pacing, Sleep Apnea, Sorin

Sorin Reply 200 with apnea monitor David Prutchi PhD www.implantable-device.comSorin announced today CE mark approval and the European commercial launch of the REPLY ™ 200 family of pacemakers featuring Sleep Apnea Monitoring (SAM).  According to the press release:

Sleep apnea is highly prevalent and vastly undiagnosed in pacemaker patients. It increases the mortality risk and the risk of common cardiovascular co-morbidities such as hypertension, atrial fibrillation (AF) and heart failure (HF). Moreover, sleep apnea complicates the management of common cardiovascular co-morbidities.

The REPLY 200 SR and DR pacemakers automatically screen patients for the risk of severe sleep apnea using a highly reliable sensor that measures ventilation. The Respiratory Disturbance Index (RDI), calculated and reported by the pacemaker, has been validated against polysomnography, the gold standard method used to diagnose sleep apnea.

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Sorin Receives FDA Approval for SMARTVIEW™ Remote Monitoring Solution

Posted on by Posted in Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Sorin, Tachycardia

Sorin Paradym Smartview www.implantable-device.com David Prutchi PhD

Sorin today announced it received FDA approval for and is beginning the U.S. launch of the SMARTVIEW™ remote monitoring solution for patients with CRM devices.  From the press release:

“Using the secure SMARTVIEW remote monitoring solution, physicians and nurses following patients with a Sorin PARADYMTM RF device can access valuable cardiac data and alert messages from the device while the patient is at home. Sorin launched the PARADYMTM RF VR and DR implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices in the United States in May 2012.

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Sorin Receives Conditional FDA IDE Approval to Study its Paradym CRT-D IPG and SonRtip Hemodynamic Sensor Lead

Posted on by Posted in Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Sorin, Tachycardia

Sorin Paradym CRT-D David Prutchi PhD www.implantable-device.comSorin announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial that will enroll more than 1,000 patients in the United States and other geographies.

The SonR optimization system is comprised of the SonR hemodynamic sensor embedded in the SonRtip atrial pacing lead and the PARADYM RF SonR CRT-D device, which includes a unique algorithm to automatically optimize the patient’s atrioventricular (AV) delay and interventricular (VV) delay timing. While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. The SonR system is the first and only CRT hemodynamic sensor based system designed to automatically adjust on a weekly basis. The timing of electrical impulses delivered to the heart is based on the patient’s heart activity and need – with the goal of improving the patient’s response to CRT. Typically this device re-programming is done manually in the clinic using echocardiography.

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Glucose Fuel-Cell-Powered Implantable Devices

Posted on by Posted in Bradycardia, ELA Medical, Glucose Fuel-Cell, Museum, News, Sorin

Experimental glucose-powered fuel-cell pacemaker (1970s)

 

My friend, Dr. Alain Ripart – the Chief Scientific Officer at Ela Medical (now part of Sorin) showed me this interesting contraption from his personal collection.  It is an experimental glucose-powered pacemaker developed in the 1970s.  It generated electricity by acquiring its fuel (glucose) directly from a living body to generate enough current to charge two NiCd cells that powered the pacemaker. Continue reading→