News

SentreHeart, Lariat Suture Delivery Device, FDA, AMAZE Trial, AFib, LAA

SentreHeart Inc. announced that it has received approval for an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment in a clinical study of...

ACC, HRS, SCAI, left atrial appendage occlusion, recommendations

The American College of Cardiology (ACC), Heart Rhythm Society (HRS) and Society for Cardiovascular Angiography and Interventions (SCAI) released a new overview on the implantation of left atrial...

Boston Scientific, investors, cardiology, growth, expansion

Boston Scientific Corp. presented an overview of its continued business momentum and long-term growth strategies at a meeting with the investment community May 1.

Watchman, LAA, left atrial appendage

The long awaited U.S. Food and Drug Administration (FDA) approval of the first transcatheter left atrial appendage (LAA) occluder in March is seen by many cardiologists as a disruptive technology...

Watchman, Mount Sinai, first, eastern United States, implant

Mount Sinai experts were the first in the eastern United States on March 23 to implant the Watchman device, a newly U.S. Food and Drug Administration (FDA)-approved device that prevents stroke in...

cryoICE, Atricure, ablation probe, cryoanalgesia, thoracotomy

AtriCure Inc. announced that it has launched the availability of its cryoICE cryo ablation probe (CRYO2) to provide cryoanalgesia for temporary pain management. AtriCure’s cryoICE is the...

AtriCure Inc. announced the first two patients in the Dual Epicardial and Endocardial Procedure (DEEP) clinical study have been enrolled and treated at PinnacleHealth CardioVascular...

Here are my predictions for technologies to watch in the coming year that have the potential to fundamentally change the practice of cardiology:

October 13, 2014 — After reviewing updated data and analysis for the Boston Scientific Watchman left atrial appendage (LAA) closure device, the U.S. Food and Drug Administration (FDA) Circulatory...

AtriCure AtriClip Flex Atrial Fibrillation Therapies Cardiac Surgery LAA Occlude

AtriCure Inc. announced the introduction of the AtriClip Flex, a new device with a more flexible aluminum shaft that allows surgeons to better maneuver within a patient’s particular anatomy.

July 22, 2014 — AtriCure announced it has sold more than 34,000 AtriClip left atrial appendage (LAA) exclusion system devices worldwide.

atrial fibrillation, LARIAT

Doctors at the Stony Brook Heart Institute Electrophysiology Lab are using a new nonsurgical technique called the Lariat Suture Delivery Device to treat patients with atrial fibrillation who...

Watchman, LAA occluder, atrial fibrillation

The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably Dec. 11 in a 13-1 vote that the benefits of the Watchman...

laa occluders structural heart atrial fibrillation atricure atriclip exclusion

AtriCure Inc., a developer of solutions to treat atrial fibrillation, announced the U.S. Food and Drug Administration’s (FDA’s) approval to begin enrollment in a clinical study of AtriCure’s...

catheters cath lab ep laa occluders baylis medical torflex transseptal sheath

The U.S. Food and Drug Administration (FDA) announced a Class I recall of Baylis Medical’s TorFlex Transseptal Guiding Sheath Kit device designed for ...

LAA occluder, Watchman

According to Millennium Research Group (MRG), the anticipated Food and Drug Administration (FDA) approval of Boston Scientific's Watchman device will drive rapid growth in the market for...

Lariat Suture Device Left Atrial Appendage Occluder Stroke Risk

Shore University Medical Center is one of only a handful of hospitals in the country offering the recent U.S. Food and Drug Administration (FDA)-approved Lariat Suture Delivery Device procedure....

FDA US device innovation

With recent medical device advances have come increasing concerns about the ability of the United States to remain at the forefront of research, especially in light of stringent FDA policies...

June 28, 2013 — Maquet Cardiovascular LLC announced it has acquired LAAx Inc., a privately held company that has developed a unique mechanical occlusion device called the TigerPaw System II....