The 1st patient enrolled in C.R. Bard‘s (NYSE:BCR) Lutonix trial, which will evaluate the company’s drug-coated catheter in treatment of below-the-knee peripheral artery disease in comparison with a traditional angioplasty balloon.
The Lutonix 014 drug-coated PTA dilatation catheter is similar to a traditional angioplasty balloon, but it’s coated with a drug called paclitaxel to keep arteries open. C.R. Bard’s device is currently sold in Europe and under investigational device exemption in the States.
The Lutonix below-the-knee trial enrolled its 1st patient at the Cardiac & Vascular Institute in Gainesville, Fla., and is expected to enroll hundreds of patients at 55 medical centers in the U.S. and abroad.
"This patient population faces significant challenges and poor clinical outcomes," Dr. Arthur Lee from the Gainesville Institute said in a company statement. "Drug coated balloons potentially offer a new hope for more durable and long term clinical outcomes for patients facing critical limb ischemia."
The company took a huge hit in Q1 from nearly $26 million in legal costs over its transvaginal mesh products, but CFO Christopher Holland told analysts during a conference call that Bard expects to see sales growth during the 2nd quarter.