First Patient Enrolled in Infraredx’s EXPANSE PTCA Study

Infraredx’s EXPANSE PTCA study has officially begun.

The first patient has been enrolled in the trial, courtesy of Cardiology Associates of North Mississippi in Tulepo, Miss. The study will be conducted in the United States to evaluate safety and effectiveness of the Lacrosse NSE (Non-Slip Element) ALPHA coronary dilatation balloon catheter during percutaneous coronary intervention (PCI) in patients with stenotic coronary arteries.

“The catheter is the first platform to score plaque, crack calcium and provide grip to secure position in the lesion during inflations without metallic components,” said Mitch Krucoff, M.D., professor of Medicine/Cardiology and Director, Cardiovascular Devices Unit, Duke University Medical Center. “This design thus brings unique profile, deliverability, tracking and flexibility to the PCI armamentarium.”
 
The Lacrosse NSE ALPHA has unique nylon elements on the exterior of the balloon that focus dilation force to reduce balloon slippage during inflation in hard or fibrotic coronary lesions. The distinctive design allows it to be used with other devices.
 
First introduced in Japan, the Lacrosse NSE ALPHA is now available in more than 30 countries throughout Asia-Pacific, India, Middle East, Europe and Latin America. 
 
Infraredx, a Nipro Company, provides cardiologists with the imaging tools required to predict and ultimately prevent heart attacks. Its Makoto Intravascular Imaging System, with accompanying Dualpro IVUS+NIRS catheter, is touted as the only technology on the market that is U.S. Food and Drug Administration-cleared for the detection of lipid core plaque (LCP) and the identification of patients and plaques at increased risk of major adverse cardiac events (MACE). Infraredx is a wholly owned subsidiary of the Nipro Company.