Heart Rhythm

Hearts should have normal rhythm to their beats, but when these beats are out of synch, it causes inefficient pumping of blood. Irregular heart arrhythmias occur when the electrical signals that coordinate the heart's beats do not work properly. This can cause beats that are too fast (tachycardia), or too slow (bradycardia). Tachycardias include atrial fibrillation (AFib), supraventricular tachycardia, ventricular fibrillation, and ventricular tachycardia (VT). Bradycardias include sick sinus syndrome and conduction block. Electrophysiology arrhythmia treatments include medications, life style changes, and the EP lab interventions of catheter ablation, and implantable pacemakers or defibrillators.

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its INGEVITY+ pacing leads to be used for left bundle branch area pacing (LBBAP) when connected to a single- or dual-chamber pacemaker.

FDA approves Boston Scientific leads for left bundle branch area pacing

Boston Scientific's INGEVITY+ pacing leads were originally approved by the FDA back in 2019. They can now be used for LBBAP, a new alternative to biventricular pacing.

money business cash flow dollar

Merit Medical to purchase Cook Medical’s lead management portfolio for $210M

Two medical device companies have announced a transaction that could shake up the U.S. electrophysiology market. 

Biotronik has received U.S. Food and Drug Administration (FDA) approval to make its Solia S lead and Selectra 3D catheter available for a new indication: left bundle branch area pacing (LBBAP).

FDA approves Biotronik lead, catheter for left bundle branch area pacing

LBBAP is a relatively new alternative to biventricular pacing. The FDA's decision was based largely on data from the BIO-CONDUCT clinical trial.

cardiologists evaluating the human heart to provide a treatment strategy

Treating AFib with another ablation after PVI provides little value

Care teams regularly targeting AFib symptoms with LVA ablation in addition to PVI may want to reconsider. 

The MODULAR ATP study demonstrated a high rate of successful leadless pacemaker implantation with few complications and stable pacing parameters. The system uses the Emblem Subcutaneous Implantable Defibrillator (S-ICD) System and the new Empower Leadless Pacemaker from Boston Scientific.

Completely leadless cardiac rhythm management system impresses

According to new MODULAR ATP data, the leadless system was associated with a high success rate and few complications. Boston Scientific plans on seeking FDA approval in 2025. 

doctor examines patient data on their tablet

PaceMate acquires Medtronic workflow tech, promising ‘unparalleled support’ for heart patients

The Florida-based healthcare company, already a leading name in cardiac data management, said the acquisition will help its technology reach more heart teams than ever before.

The U.S. Food and Drug Administration (FDA) has announced that Defibtech, a Nihon Kohden company, is recalling its RMU-2000 ARM XR Chest Compression Device due to significant safety concerns. This is a Class I recall, which means the FDA believes using the device “may cause serious injury or death.”

Automated chest compression device recalled after patient death

Regulators emphasized that these devices should not be used due to significant safety risks. 

Left atrial appendage occlusion (LAAO) with the Watchman FLX device from Boston Scientific is associated with positive outcomes and limited adverse events after one year, according to new findings published in Circulation: Cardiovascular Interventions.[1] Many prior Watchman FLX studies, including PINNACLE FLX, had focused on the device’s performance in a controlled setting. The study’s authors hoped to gain a better understanding of its real-world impact by reviewing registry data from more than 97,000 U.S

LAAO with Watchman FLX associated with positive 1-year outcomes, real-world data confirm

Researchers hoped to gain a better understanding of the device's real-world impact by reviewing registry data from more than 97,000 U.S. patients. Overall, the Watchman FLX was linked to positive data and limited adverse events one year after treatment.