Technology | May 19, 2015

FDA Clears Sutureless Epicardial Pacing Leads

Leads can be used in patients contraindicated for traditional leads

Greatbatch Medical, Myopore Sutureless Myocardial Pacing Lead

May 19, 2015 — A new epicardial pacing lead has been cleared by the U.S. Food and Drug Administration (FDA) as an option for the implant of a pacemaker, defibrillator, or cardiac resynchronization therapy (CRT) device. The lead is indicated when other types of leads cannot be implanted. Examples include patients who have small veins, congenital heart disease, abnormalities of the tricuspid valve or when other leads are already in place, preventing additional leads in the veins.

The Myopore Sutureless Myocardial Pacing Lead from Greatbatch Medical is a surgically implanted, insulated and sutureless wire with a screw-in tip that is part of a permanently implanted pacemaker, defibrillator or CRT device. The lead is implanted by opening the chest or a making a small incision under the breastbone. It is then placed on the surface of the heart muscle so the screw-in tip end can electrically stimulate (pace) the ventricles.

When placed on the surface of the heart as part of a pacemaker, the Myopore Lead paces the heart to assure that it beats at an appropriate rate. A CRT device uses two leads, one to pace each ventricle, either of which may be a Myopore Lead. A CRT device with two leads is intended to coordinate and improve the ventricles' timing to reduce symptoms of heart failure.

The Myopore Lead should not be used when a patient's heart is too thin or damaged and should not be implanted on the surface of the atria.

For more information: www.greatbatchmedical.com

Related Content

Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
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 Initiates U.S. Pivotal Study of Amplatzer Device for Patent Ductus Arteriosus
News | Congenital Heart| September 05, 2017
Abbott announced it has initiated a U.S. pivotal clinical study evaluating the safety and effectiveness of a modified...
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
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.
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Overlay Init