After four years of tussling and cajoling with the Food and Drug Administration, a Maple Grove start-up has won the agency's clearance to market a device that treats brain aneurysms.
The cPAX Aneurysm Treatment System from NeuroVasx received a type of approval intended for "humanitarian" use -- meaning it will treat patients with a condition that affects fewer than 4,000 people in the United States a year.
The device treats large cerebral aneurysms, weak spots on a blood vessel in the brain that fill with blood and can be fatal if they burst and cause a stroke. About 320,000 people suffer from the condition a year, but the NeuroVasx device is cleared only for the largest aneurysms.
The company initially applied to the FDA in 2007 for 510(k) clearance -- a common way for medical devices to be approved in the United States that usually doesn't require clinical studies on patients.
However, in recent years, the process has come under fire from consumer groups that charge it permits potentially unsafe devices on the market. In addition, leadership at the FDA changed after President Obama's election, causing more delays for companies in the middle of the approval process.
All of this caused confusion and concern for NeuroVasx. "It was really rough sledding for a while there," Chief Executive Eric Timko said.
Now that NeuroVasx has the go-ahead for a limited number of patients, it can initiate a 113-patient clinical trial to support an application for approval to treat a wider scope of patients, Timko said.
The study will compare NeuroVasx's polymer coiling product to those made by competitors such as Boston Scientific and EV3. The devices are snaked into the brain from an artery in the groin in a minimally invasive procedure.
