Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today the enrollment of the first patient in its EXPANSE PTCA study (NCT04985773) at the Cardiology Associates of North Mississippi in Tupelo, Mississippi.
The study will be conducted in the United States with the objective 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 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 over 30 countries throughout Asia-Pacific, India, Middle East, Europe and Latin America, and is being very well received, with hundreds of thousands of units sold.
“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, MD, and Professor of Medicine/Cardiology and Director, Cardiovascular Devices Unit, Duke University Medical Center. “This novel design thus brings unique profile, deliverability, tracking and flexibility to the PCI armamentarium.”