Atritech commences enrollment in WATCHMAN Left Atrial Appendage Closure Device study in AF patients

Atritech, Inc. today announced initial enrollment into its confirmatory study, PREVAIL, comparing the WATCHMAN® Left Atrial Appendage Closure Device to long term warfarin therapy in patients with atrial fibrillation.  Doctors at Central Baptist Hospital in Lexington, Kentucky enrolled the first patient.

The WATCHMAN® Device is designed to keep harmful sized blood clots from entering a patient's blood stream, potentially causing a stroke.  Patients with atrial fibrillation (a heart condition which causes the upper chambers of the heart to beat too rapidly) are at a greater risk of having a stroke due to the formation of clots in an area of the heart called the left atrial appendage (LAA).  Typically these patients require blood thinning medications such as warfarin to prevent these clots from forming in the heart.  The WATCHMAN® Device may be a viable alternative for patients with atrial fibrillation who may not want to take blood thinning medications for life.  

The PROTECT AF clinical study evaluated the WATCHMAN versus the current standard of care, warfarin, in patients with non-valvular atrial fibrillation.  The study enrolled 800 patients from February 2005 to June 2008 and demonstrated a 30% reduction in the combined risk of cardiovascular death and stroke.  The WATCHMAN received Circulatory Panel Approval in the United States in April, 2009, however the FDA requested a smaller confirmatory study be conducted before granting full approval.  

Since the positive panel vote, additional data on the safety and efficacy of the WATCHMAN device has been presented.   The most recent data presented at the TCT meeting in Washington DC, continues to demonstrate a relative risk reduction of 30% for all stroke, cardiovascular death and systemic embolism compared to long term warfarin therapy with an average follow up of 27 months.  Additionally, data on procedural safety demonstrated a significant improvement in the safety profile of the WATCHMAN LAA closure procedure with increased operator experience.  

Dr. Gery Tomassoni, Director of Research at Central Baptist Hospital in Lexington, Kentucky enrolled the first patient into the PREVAIL study.  "We are pleased to have enrolled the first patient in the PREVAIL study.  Our experience in the PROTECT AF study was very positive.  We look forward to being a major enrolling center in this study and being able to offer an alternative to long term anticoagulation therapy to our patients."  

"We are excited to begin enrollment in the PREVAIL study" said Jim Bullock, President and CEO of Atritech.  "As the market leader in the development and study of LAA closure, with over 8 years of clinical experience, Atritech is excited to enter this final phase to obtain U.S. approval of the WATCHMAN device."

Atritech received full FDA approval of its confirmatory study, PREVAIL, in late September and is expected to complete enrollment by mid- 2012. The WATCHMAN device is commercially available in Europe and other major geographies outside of the United States.