Cardiovascular Systems Inc. of New Brighton has received regulatory approval to enroll 429 patients in a clinical study testing a device that treats clogged arteries.
The go-ahead came after the Food and Drug Administration (FDA) reviewed data from the first 50 cases in the study, the company said Tuesday.
The study is evaluating the safety and effectiveness of the company's Diamondback 360 System to treat calcified coronary arteries by sanding and removing hardened plaque. Typically, the system has been used to treat hardened plaque in leg arteries.
David Martin, CSI's president and CEO, says the use of the Diamondback system may make cardiac stent placement more effective, or it could avoid the trauma and cost of heart bypass surgery.
CSI first received FDA approval to begin the study in April 2010. Approximately 50 U.S. hospitals are involved in the study, and Dr. Jeffrey Chambers, an interventional cardiologist with Metropolican Cardiovascular Consultants in Coon Rapids is the study's primary investigator.
Results from the first 50 patients found the device worked in 98 percent of the patients, the company said.
Janet Moore covers medical technology for the Star Tribune.
