Technology | January 19, 2015

FDA Grants HDE For Pacemaker That Regulates Hypertension

Device used to control drug-resistant hypertension via implantable pulse generator

CVRx, Barostim neo Legacy System, pacemaker, hypertension, FDA, HDE

January 19, 2015 — The U.S. Food and Drug Administration (FDA) has granted a humanitarian device exemption for the CVRx Inc. Barostim neo Legacy System.

The Barostim neo System is a programmable, minimally invasive device that consists of an implantable pulse generator (IPG), a 2-mm electrode and an external programmer. Barostim therapy is designed to trigger the natural blood pressure regulation system by electrically activating the carotid baroreceptors. The device is commercially available in Europe and the United States. The therapy is included in the joint European Society of Hypertension and European Society of Cardiology guidelines for the treatment of resistant hypertension published in June 2013.

The system is completed by connecting the IPG to electrical stimulation lead electrodes placed on the carotid sinus nerves on each side of the neck. The device provides controlled delivery of high-frequency, small electrical stimulation pulses to the carotid sinus. This has been shown to provide probable benefit to patients with resistant hypertension who have already been determined to respond to this treatment by lowering their systolic and diastolic blood pressure.

The Barostim neo Legacy System may be used in patients with resistant hypertension who were previously implanted in clinical trials with the Rheos Carotid Sinus Leads Models 1010R, 1010L, 1014L, and 1014R which have now been discontinued and are no longer available. Specifically, the approved IPG will replace an existing IPG in a patient whose battery is depleted and needs to be replaced and/or electrode lead repair procedures are necessary.

Use of the Barostim neo Legacy System may help patients who achieved a significant lowering of their blood pressure during their participation in the clinical trial to maintain those results. Clinical trial results showed that in these patients the systolic and diastolic blood pressure was lowered by an average of 33.6 mmHg and 17.5 mmHg, respectively.

For more information:

Related Content

LivaNova Enters Binding Letter of Intent to Sell Cardiac Rhythm Management Business
News | EP Lab | January 26, 2018
January 26, 2018 — LivaNova PLC and MicroPort Scientific Corp.
Societies Detail Treatment for Patients With Ventricular Arrhythmias
News | EP Lab | October 30, 2017
The American College of Cardiology, along with the American Heart Association and the Heart Rhythm Society, published...
Baylis Medical and Siemens Co-Sponsor Transseptal Access Training Course
News | EP Lab | October 18, 2017
Baylis Medical Co. Inc. and Siemens Healthineers are co-sponsoring a first-of-its kind training program aimed at...
Spectranetics Initiates Class I Recall for Bridge Occlusion Balloon Catheter
News | EP Lab | September 27, 2017
Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab | September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab | August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Ohio State Researchers Prove Human Heart's 'Battery' Has Multiple Backups
News | EP Lab | July 27, 2017
July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural...
Biosense webster multielectrode balloon RF ablation catheter

The Biosense Webster multi-electrode balloon RF ablation catheter. Each electrode can have varied power settings to avoid damage to underlying tissues like the esophagus. 

Feature | EP Lab | June 22, 2017 | Dave Fornell
Electrophysiology (EP) technology has been advancing rapidly the past few years with new ablation tools to improve...
Videos | EP Lab | May 26, 2017
DAIC Editor Dave Fornell takes a tour of some of the most innovative new electrophysiology (EP) technology at the 201
Videos | EP Lab | May 17, 2017
This video, provided by Spectranetics, demonstrates how to deploy the Bridge Occlusion Balloon used to seal accidenta
Overlay Init