Once more a device with substantial credentials is taking a long time to make the leap from CE marking to FDA approval. We report here on the first Latin American implants of Boston Scientific’s WATCHMAN Left Atrial Appendage Closure Device which was launched in Europe two years ago.
FDA approval will be contingent upon satisfactory completion of a US study in which patient enrollment is not expected to be complete until next quarter. According to Boston Scientific, nearly 1,800 patients have now been recruited in WATCHMAN clinical trials with more than 2,700 patient-years of follow-up.
“The WATCHMAN device has been well received in many CE Mark countries and we look forward to beginning commercial launch in select Latin American markets this quarter”
Boston Scientific Corporation’s WATCHMAN® Left Atrial Appendage (LAA) Closure Device was developed by Atritech, which Boston Scientific acquired in March 2011 and was commercialized outside the United States following gaining CE mark status in 2009. The novel 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.
The WATCHMAN LAA Closure Device 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 implants in Latin America have now been performed by Bernardo Caicedo, M.D., Interventional Cardiologist, at Angiografia de Occidente in Cali, Colombia.
“I am excited to be part of the first patient implants of the WATCHMAN device in Latin America,” said Dr. 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.”
The WATCHMAN Device 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 WATCHMAN clinical trials with more than 2,700 patient-years of follow-up. The WATCHMAN device is CE Marked and was commercialized outside the United States in 2009.
“The WATCHMAN device has been well received in many CE Mark countries and we look forward to beginning commercial launch in select Latin American markets this quarter,” said Hank Kucheman, Chief Executive Officer for Boston Scientific. “We are pleased to bring this technology to more customers and their patients worldwide.”
Boston Scientific is currently enrolling U.S. patients in the PREVAIL study, a confirmatory study designed to gain Food and Drug Administration approval.
Source: Boston Scientific, medlatest staff