Search Results

EVEREST II High-Risk Registry Reported for MitraClip

May 6, 2010—Saibal Kar, MD, presented data from the Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) High-Risk registry at the Society for Cardiovascular Angiography and Interventions (SCAI) 33rd annual scientific sessions in San Diego.

Boston Scientific’s Watchman FLX Evaluated in PINNACLE FLX Trial

April 6, 2021—Boston Scientific advised that 12-month results from the PINNACLE FLX trial were published online by Saibal Kar, et al online ahead of print in Circulation.

Evalve's EVEREST II High-Risk Registry Data Presented

May 20, 2009—Evalve, Inc. (Menlo Park, CA) announced results showing that percutaneous mitral repair using the company's MitraClip system in symptomatic high-risk surgical patients with either functional mitral regurgitation (FMR) or degenerative mitral regurgitation (DMR) improves patient clinical status.

Evalve's EVEREST II High-Risk Registry Data Presented

May 20, 2009—Evalve, Inc. (Menlo Park, CA) announced results showing that percutaneous mitral repair using the company's MitraClip system in symptomatic high-risk surgical patients with either functional mitral regurgitation (FMR) or degenerative mitral regurgitation (DMR) improves patient clinical status.

IDE Approved for Trial of Carag’s Transcatheter Bioresorbable Septal Occluder

July 1, 2020—Carag AG, a Switzerland-based medical device company, announced it has received FDA investigational device exemption approval for the Carag bioresorbable septal occluder (CBSO), the company’s transcatheter septal occluder with a bioresorbable, metal-free framework.

First Commercial Procedures in the United States Performed With Boston Scientific's Watchman Device

March 24, 2015—Boston Scientific Corporation announced the initial commercial use of its Watchman left atrial appendage closure device, which offers a novel reduced stroke risk option for high-risk patients with nonvalvular atrial fibrillation (AF) as an alternative to long-term warfarin therapy.

atHeart Medical’s reSept ASD Occluder Studied in ASCENT ASD United States Pivotal Trial

July 14, 2021—atHeart Medical announced the enrollment of the first five patients in ASCENT ASD, a United States investigational device exemption pivotal trial.

Two-Year Data From TRILUMINATE Pivotal Study Presented for Abbott’s TriClip TEER System

March 31, 2025—Abbott announced late-breaking data from its TRILUMINATE pivotal trial of the TriClip transcatheter edge-to-edge repair (TEER) system to treat tricuspid regurgitation (TR).

Data Presented on MitraClip for Treating High Risk and Elderly Patients

May 5, 2011—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that the MitraClip system (Abbott Vascular, Santa Clara, CA) is showing consistent performance in three analyses of its safety and effectiveness in high-risk patients, which were presented at the 2011 SCAI scientific sessions in Baltimore, Maryland.

CE Mark Approved for Boston Scientific's Next-Generation Watchman FLX LAA Closure Device

November 19, 2015—Boston Scientific announced European CE Mark approval for the Watchman FLX left atrial appendage (LAA) closure device.

MID’s MIA-T Tricuspid Annuloplasty System Receives IDE Approval for Pivotal Trial

October 20, 2025—Micro Interventional Devices (MID) announced that the FDA has approved an investigational device exemption (IDE) for its MIA-T minimally invasive annuloplasty–tricuspid technology to be used for the treatment of tricuspid annular disease in the STTAR-US pivotal clinical trial.

Boston Scientific Initiates CHAMPION-AF Trial of the Watchman FLX

October 29, 2020—Boston Scientific Corporation announced it has initiated the CHAMPION-AF clinical trial to evaluate the safety and efficacy of the Watchman FLX left atrial appendage closure (LAAC) device within a broad population of patients with nonvalvular atrial fibrillation (NVAF), including those who are at low-to-moderate risk of bleeding from the use of anticoagulation.

Enrollment Commences in Pivotal Trial of Biosense Webster Laminar LAAX Device

February 27, 2024—Biosense Webster, Inc., a part of Johnson & Johnson MedTech, announced the commencement of patient cases with the investigational Laminar left atrial appendage elimination (LAAX) system as part of its pivotal investigational device exemption (IDE) study of the system.

FDA Approves Abbott's Next-Generation MitraClip Device

July 12, 2018—Abbott Vascular announced approval from the FDA for the company's third-generation MitraClip transcatheter heart valve repair device.

Boston Scientific’s Watchman FLX Meets 24-Month Secondary Efficacy Endpoint in PINNACLE FLX Trial

July 21, 2021—Boston Scientific announced the 24-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the company’s next-generation Watchman FLX left atrial appendage (LAA) closure device for patients with nonvalvular atrial fibrillation (NVAF).

FDA Approves REPAIR MR Trial for Abbott's MitraClip in Patients at Moderate Surgical Risk

January 13, 2020—Abbott announced that the FDA has approved a clinical trial that will compare the effectiveness of the company’s transcatheter MitraClip device to mitral valve surgical repair in patients with primary mitral regurgitation (MR) who are eligible for open heart surgery.