News | November 18, 2011

First Patients Implanted with Watchman LAA Occluder in Latin America

November 18, 2011 – Boston Scientific’s Watchman left atrial appendage (LAA) closure device has been implanted in the first patients in Latin America. The device is designed for use in patients in atrial fibrillation who are at risk for stroke and are eligible for long-term oral anticoagulation therapy such as warfarin. Watchman is intended to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation. The first patient implants were performed by Bernardo Caicedo, M.D., interventional cardiologist, at Angiografia de Occidente in Cali, Colombia.

Atrial fibrillation, which affects approximately 15 million patients worldwide, is a disorder that disrupts the heart's ability to beat regularly and pump blood efficiently. Patients in atrial fibrillation are at greater risk for stroke due to the formation and migration of clots in the left atrial appendage. Anticoagulants such as warfarin have traditionally been the only therapy for reducing stroke risk in these patients. Watchman is intended to be an alternative to long-term anticoagulation. It is designed to close the LAA, thereby preventing clots within the appendage from being dislodged into the bloodstream.

"I am excited to be part of the first patient implants of the Watchman device in Latin America," said Caicedo. "The percutaneously delivered device promises to offer a safe and effective alternative for atrial fibrillation patients who cannot take long-term oral anticoagulants and have limited options to reduce their stroke risk. It incorporates a pre-loaded device that is both repositionable and retrievable to enhance its ease of use."

Watchman is the most clinically studied product of its kind currently available. In the multi-center, randomized PROTECT AF clinical trial, it proved to be non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for a combined measure of stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy in 800 patients. The study also showed a 29 percent relative risk reduction in all stroke and a 90 percent relative risk reduction in hemorrhagic stroke compared to warfarin. Nearly 1,800 patients have now been recruited in Wacthman clinical trials with more than 2,700 patient-years of follow-up. Watchman is CE Marked and was commercialized outside the United States in 2009.

Boston Scientific is currently enrolling United States patients in the PREVAIL study, a confirmatory study designed to gain U.S. Food and Drug Administration (FDA) approval. Enrollment is expected to be completed in the first quarter of 2012. In the United States, Watchman is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Atritech, which Boston Scientific acquired in March 2011.

For more information: www.bostonscientific.com

 

Related Content

MaxQ AI Launches Accipio Ax Slice-Level Intracranial Hemorrhage Detection
Technology | Stroke | May 21, 2019
Medical diagnostic artificial intelligence (AI) company MaxQ AI announced that Accipio Ax will begin shipping in August...
Brain images that have been pre-reviewed by the Viz.AI artificial intelligence software to identify a stroke. The software automatically sends and alert to the attending physician's smartphone with links to the imaging for a final human assessment to help speed the time to diagnosis and treatment. Depending on the type of stroke, quick action is needed to either activate the neuro-interventional lab or to administer tPA.

Brain images that have been pre-reviewed by the Viz.AI artificial intelligence software to identify a stroke. The software automatically sends and alert to the attending physician's smartphone with links to the imaging for a final human assessment to help speed the time to diagnosis and treatment. Depending on the type of stroke, quick action is needed to either activate the neuro-interventional lab or to administer tPA. Photo by Dave Fornell.

Feature | Stroke | May 17, 2019 | Inga Shugalo
With its increasing role in medical imaging, ...
Videos | Stroke | May 16, 2019
This is an example of a carotid artery reporting module from Change Healthcare at...
 UTHealth Research Finds Telemedicine Stroke Patients Receive Consistent Care 24/7
News | Stroke | April 24, 2019
Stroke patients examined remotely by a teleneurologist were treated as quickly and effectively after hours as during...
New Stroke Training Model Improves Access to Life-Saving Care
News | Stroke | March 27, 2019
Training interventional radiologists to perform endovascular thrombectomies results in positive outcomes for patients...
Gregory W. Albers, M.D., Receives Distinguished Clinical Research Achievement Award for Stroke Research
News | Stroke | March 19, 2019
iSchemaView announced the company’s co-founder Gregory Albers, M.D., has received the Distinguished Clinical Research...
Corindus Seeking Neurovascular Intervention Clearance for CorPath GRX Vascular Robotic System
News | Stroke | February 15, 2019
Corindus Vascular Robotics Inc. is seeking premarket clearance from the U.S. Food and Drug Administration (FDA) to use...
NeuroLogica and MaxQ AI Announce Distribution Agreement
News | Stroke | November 30, 2018
Clinical diagnostics intelligence platform company MaxQ AI and Samsung NeuroLogica announced a distribution agreement...
Medication Alone May Not Eliminate Stroke Risk in Carotid Atherosclerotic Stenosis Patients
News | Stroke | October 31, 2018
Recent statin and medication advances have led some researchers to suggest surgical treatments for carotid stenosis...
Overlay Init