News | July 06, 2012

Boston Scientific Completes Patient Enrollment in PREVAIL Study for First-in-Class Watchman Device

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 Appendage (LAA) Closure device. The prospective, randomized trial enrolled 407 patients at 42 sites and is comparing the Watchman device to warfarin in high-risk patients with atrial fibrillation (AF) eligible for long-term warfarin therapy. Patient follow up of six months is required prior to submission to the FDA.

The PREVAIL study began enrollment in November 2010. Patients were randomly selected to receive either the Watchman device or remain on long-term warfarin therapy. Those selected to receive the Watchman device remained on warfarin for 45 days following implant.

Watchman has been studied in more than 2,000 patients, exceeding 4,000 patient-years of follow up. The evidence-based clinical program for Watchman includes two landmark studies: the PROTECT AF trial and the ASA Plavix (ASAP) study. In the multi-center, randomized PROTECT AF trial, the Watchman device proved to be non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy in 707 patients. Data from the prospective, multi-center ASAP study showed a 77 percent reduction of ischemic stroke risk in patients with AF implanted with the Watchman device and not eligible for blood-thinning medications.

Watchman is a novel device manufactured by Boston Scientific Corporation that is introduced into the heart via a flexible tube (catheter) through a vein in the groin and closes off the LAA. The device is designed to capture any clots that may form in the appendage, reducing the risk of stroke and potentially eliminating the need for long-term use of blood-thinning medications.

Atrial fibrillation affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. Patients in AF are at a greater risk for stroke due to the migration of clots formed in the LAA. Blood-thinning medications have previously been the only therapy for reducing stroke risk in these patients.

The Watchman device was approved for marketing in Europe and some countries in Asia in 2005. It is contraindicated in patients who are not eligible for anticoagulation therapy.

In the United States, the Watchman device 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.Atritech.net

Related Content

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo