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Electrophysiology & Arrhythmia

 

Medtronic will present data on its Micra Transcatheter Pacing System to an FDA advisory committee on Feb. 18. The Micra, a miniature leadless pacemaker, is not yet FDA-approved.

 

Recent Headlines

Abbott acquires Kalila Medical, expands heart rhythm disorder portfolio

Abbott announced on Feb. 2 that it acquired Kalila Medical, a privately held company that develops medical devices to treat atrial fibrillation and other heart rhythm disorders. Terms of the deal were not disclosed.

Medtronic to present data on Micra transcathter pacing system to FDA committee

Medtronic will present data on its Micra Transcatheter Pacing System to an FDA advisory committee on Feb. 18. The Micra, a miniature leadless pacemaker, is not yet FDA-approved.

St. Jude Medical announces Class 1 recall of Optisure dual coil defibrillation leads

St. Jude Medical announced on Jan. 22 that the FDA had classified a previous voluntary recall of the company's Optisure dual coil defibrillation leads as a Class 1 device recall.

National standards society renews IBHRE certification programs

The American National Standards Institute (ANSI) renewed the International Board of Rhythm Heart Examiners (IBHRE) accreditation and certification programs, according to an IBHRE news release.

ICDs are associated with improved survival in older adults with heart failure

Adults with heart failure who received implantable cardioverter defibrillators (ICDs) for primary prevention had a significant survival advantage compared with those who did not receive ICDs, according to a propensity score-matched analysis of Medicare patients.

Waiting for Closure: Left Atrial Appendage Occlusion & Reimbursement Policy

Months after the U.S. FDA approved a device with the potential to close the source of many atrial fibrillation-related strokes, hospitals, cardiologists and patients find themselves in a holding pattern increasingly common for newly emerging therapies: They are waiting for the CMS to issue a national coverage determination for LAA occlusion.

FDA approves Biotronik ICD systems for use with MRI scans

The FDA approved the ProMRI implantable cardioverter defibrillator (ICD) systems for use with full-body MRI scans on Dec. 22.

FDA approves LifeVest wearable cardioverter defibrillator for children

The FDA approved the LifeVest wearable cardioverter defibrillator (Zoll Lifecor Corp.) on Dec. 17 to treat some children who are at risk for sudden cardiac arrest. The device was approved in 2001 for adults who were at least 18 years old.

Medical societies release consensus statement on ICD programming and testing

Major electrophysiology and cardiology societies released an expert consensus statement on Nov. 19 on optimal implantable cardioverter-defibrillator (ICD) programming and testing.

FDA approves app-based remote monitoring system for patients with implantable pacemakers

On Nov. 17, the FDA approved the MyCareLink Smart Monitor, the first app-based remote monitoring system in the U.S. for patients with implantable pacemakers.

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