A new clinical trial of Boston Scientific’s Watchman implant device was conducted to see how it worked in stroke prevention for AF patients. According to the trial results, the device is showing itself to be a safe alternative to anticoagulant medications like Multaq and Warfarin in terms of its bleeding risk-to-benefits ratio. It has many experts wondering if the implant could eventually replace the need for the prescription drugs altogether in the future.
The Watchman device has been approved in Europe for years, but the FDA required more studies before it will give its approval.
“In this experience focusing on safety, we were very, very pleased,” Dr. David Holmes, a cardiologist at the Mayo Clinic who led the study, said in an interview.
AF patients are highly likely to suffer from a stroke without medication. However, the medications have proven to be just as dangerous as the condition itself. For example, Multaq, made by Sanofi-Aventis, has been proven to cause such severe side effects that the FDA intervened in 2012 and reduced its recommendation of the drug for use only when other drugs fail to work. Side effects linked to Multaq include liver failure, a worsening of the heart condition and lung disease or lung toxicity. The FDA has also expressed concerns over the Watchman device implant. Complications linked to that device include build-up of fluid around the heart and stroke.
“Absolute stroke rates were low, but statistically they were less in this group of patients” — even though they were higher-risk patients, Holmes said.
While the jury is still out on whether the Watchman device will replace drugs like Multaq, right now anything is better than the risks involved with certain prescription medications.
If you or a loved one has suffered from liver failure or a worsening heart condition after being treated with Multaq, contact the attorneys at Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.