Compliance In Focus

Approximately 30,000 people suffer from ruptured brain aneurysms every year in the United States, and about 40 percent of them die as a result, according to the Brain Aneurysm Foundation.

Neurovascular stents are commonly used to treat unruptured brain aneurysms. However, the FDA last year issued guidance to healthcare providers about the risks of using neurovascular stents for stent-assisted coiling, warning that the risks of this treatment may outweigh the benefits for many patients.

The FDA recently approved a medical device designed to treat brain aneurysms by restricting and diverting blood away from the aneurysm, preventing it from growing and rupturing.

Here’s a closer look at how it works and how new treatments like this one could transform the way we treat brain aneurysms.

Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives.