Protect AF - Watchman to Warfarin 2:1
- 707 patients enrolled; 900 patient years of follow-up
- 100 patients out 3 years, 300 patients out 1 year
- Primary Efficacy: All Stroke, CV Death, Systemic Enbolism.
- Primary Safety: Serious Effusion, Device Embolization, Bleeding Events
Device Group: CHADS2 Score 2.2
- 90% Implant Success
- 87% of patients ceased warfarin at 45 days
- 93% of patients ceased warfarin at 6 months
Control Group: CHADS2 Score 2.3- 55% INR’s within therapeutic range
Intent to Treat
- 32% reduction in primary efficacy
- 26% reduction in all stroke
- 91% reduction in hemorrhagic stroke
Successful Treatment
- Device implanted & off warfarin to warfarin therapy
- 56% reduction in primary efficacy
- ##% reduction in stroke risk
- 100% reduction in hemorrhagic stroke
Primary Safety
- Relative risk 2:1 (device to control)
- Average extended hospital stay – 5 days
- No long term sequelae
FDA Advisory Panel Votes 7 to 5Medscape Today – Michael O’Riordan – April 24, 2009 A US Food and Drug Administration advisory panel voted 7 to 5 in favor of approving ... READ MORE... |
Circulatory System Devices Panel MeetingU.S. Food and Drug Administration – Center for Devices and Radiological Health – April 23, 2009 A meeting of the Circulatory System Devices Panel was ... READ MORE... |
Divided FDA Panel Recommends ApprovalMedpage Today – John Gever, Senior Editor – April 23, 2009 A novel parachute-shaped cardiac device is comparable to warfarin (Coumadin) for treating patients with ... READ MORE... |
FDA Panel Narrowly Recommends Approvaltctmd – Caitlin E. Cox – April 27, 2009 A percutaneously implanted left atrial appendage occlusion device won the recommendation of a US Food and ... READ MORE... |
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Heart Rhythm 20095/13/2009 – Boston, MA Science, discovery and innovation represent the driving forces behind this year’s Scientific ... READ MORE... |
Sixth Annual EP Fellows Conference5/12/2009 – Boston, MA Sixth Annual EP Fellows Conference provides a forum for EP Fellows to discuss the latest breakthroughs in clinical ... READ MORE... |
American Association for Thoracic Surger5/10/2009 – Boston, MA The American Association for Thoracic Surgery (AATS) is an international organization of over 1,200 of the world’s foremost cardiothoracic surgeons.READ MORE... |
Society of Cardiovascular Angiography an5/06/2009 – Las Vegas, NV The Scientific Sessions and course program represent a unique forum driven by the issues of the day in interventional ... READ MORE... |
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Key Event Rates After 900 Patient-YearsMeeting of the American College of Cardiology - David R. Holmes, MD, FACC - March 28, 2009 The device showed statistical noninferiority to warfarin through ... READ MORE... |
Initial Worldwide Experience with the WADavid Holmes DR, et al– ACC 2009; Session 2402 "Randomized prospective trial of percutaneous left atrial appendage closure versus warfarin for stroke prevention in atrial ... READ MORE... |
Watching the WatchmanJournal of the American College of Cardiology – Peter C. Block, MD, FACC – March 20, 2009 Importantly, 90% of thrombi, when seen by echocardiography ... READ MORE... |
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News
- Atritech Announces Completion of a $22 Million Equity Financing
- Application for its WATCHMAN LLA Closure Technology
- Atritech Files Pre-Market Approval
- Clinical Trial Presentation
- Atritech to Participate in Late-Breaking
- Atritech Completes $30 Million Financing
- Big Day for Cardiac Electrophyslology
- Still Watching the Watchman
Events - Live
Events - Upcoming
- 9FDA Panel Review
- American Association for Thoracic Surgery 2009
- Sixth Annual EP Fellows Conference
- Sixth Annual Allied Health Professionals Conference: Electrical Management of Cardiac Rhythm Disorders Heart Rhythm 2009
- Society of Vascular Surgery Conference
- Clinical Applications & Beyond PhysicianTraining Seminar
- Changing the Pace EP Fellows Symposium
- Western Thoracic Surgical Association Annual Meeting
- American Association of Heart Failure Nurses
- Clinical Applications & Beyond Physician Training Seminar
- Electrical Management of Cardiac Rhythm Disorders
- Lawrence D. German, MD Symposium on Electrophysiology