News

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....

Simbionix ANGIO Mentor Structural Heart Simulator Models

Simbionix USA Corporation is proud to announce the release of various training modules for the ANGIO Mentor endovascular simulator.

Boston Scientific Watchmen Left Atrial Appendage Closure Atrial Fibrillation

Boston Scientific reports preliminary data in the PREVAIL clinical trial met two out of three co-primary endpoints. The data was supposed to be presented during the 2013 American College of...

March 13, 2013 — St. Jude Medical Inc. announced the first patient implant in a new pivotal trial evaluating the company’s Amplatzer cardiac plug (ACP) for the prevention of stroke.

Amplatzer Amulet St. Jude Medical Left Atrial Appendage Occluders

St. Jude Medical Inc. announced European CE mark approval of its Amplatzer Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients...

July 6, 2012 — Boston Scientific Corp. has completed enrollment in the PREVAIL confirmatory study, designed to gain U.S. Food and Drug Administration (FDA) approval for the Watchman Left Atrial...

May 14, 2012 — Boston Scientific announced results from the ASA Plavix (ASAP) Study, which studied the Watchman Left Atrial Appendage (LAA) Closure device. The data showed a reduction in the risk...

January 25, 2012 — Which Medical Device announced the winner of its Device of the Year Award 2011 in the cardiology category.

January 25, 2012 — Terumo Cardiovascular Systems announced today that it has entered into an exclusive agreement with LAAx Inc. to distribute the TigerPaw System II, a left atrial appendage (LAA)...