Boston Scientific Corporation (NYSE:BSX) today announced the first German patient enrolment in the EWOLUTION REgistry on WATCHMAN Outcomes in Real-Life Utilization, a prospective multicentre registry sponsored by the Company’s Structural Heart group. The first patient was enrolled by Professor Martin. W. Bergmann from the St. George Hospital in Hamburg, Germany.
The EWOLUTION Registry is a multi-national post market data collection on procedural success, incidence of stroke and mortality of patients implanted with a WATCHMAN™ device. The overall objective of the registry, that will enrol approximately 1.000 patients across 50 centres in 16 countries, is to compile real-world clinical outcomes data and real-world usage data for the WATCHMAN™ device.
“It is a great pleasure to announce that the first German patients of the EWOLUTION Registry on interventional LAA closure (LAAC) in Atrial Fibrillation (AF) patients have been enrolled,” said Professor Martin W. Bergmann, St. George Hospital, Hamburg, Germany, and EWOLUTION Registry co-Principal Investigator. “Randomized clinical trials like PROTECT AF, ASAP and PREVAIL have shown the efficacy and safety of LAAC device therapy for stroke risk reduction in non-valvular AF patients. Recent data suggest that the therapy can achieve even better results than the previous gold standard, namely oral anticoagulation with Marcumar.”
Currently, the WATCHMAN™ LAA Closure Device is used in Europe to prevent thrombus embolization from the LAA and reduce the risk of life-threatening bleeding events in patients with non-valvular AF who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy. Recently published data from the ALSTER registry summarizing the outcome of 60 patients treated in Hamburg have been able to confirm the positive results in everyday practice.
“The EWOLUTION Registry is the largest registry ever done in the field of LAAC therapy and will provide us with invaluable insights into patient selection and therapeutic strategies in daily practice,” said Professor Bergmann.
“The WATCHMAN device is already supported by the largest amount of randomized clinical trial data of any device technology for the prevention of stroke in high risk patients with atrial fibrillation,” said Dr Kenneth Stein, Senior VP, Chief Medical Officer Cardiac Rhythm Management at Boston Scientific. “The EWOLUTION Registry will complement that data with an impressive amount of additional information on the real world outcomes of patients being treated with the WATCHMAN device. Studies like EWOLUTION demonstrate our commitment to continue to lead the field by investing in the clinical science necessary to prove the value of our innovative new technologies.”
Boston Scientific expects to present preliminary first data from the EWOLUTION Registry by 2015.
The WATCHMAN™ Left Atrial Appendage Closure Device received CE Mark approval in Europe in 2005.
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