BD to Begin Real-World Data Registry for Rotarex Atherectomy System

BD (Becton, Dickinson and Company) revealed plans to begin a patient data registry for its Rotarex atherectomy system to measure real-world outcomes for patients suffering from peripheral artery disease (PAD).

Rotarex is a minimally invasive solution to efficiently remove plaque and thrombus in peripheral arteries. It has dual indications for both atherectomy and thrombectomy.

The XTRACT registry study will evaluate Rotarex to treat U.S. patients with PAD lesions. Co-principal investigators Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon, will lead the registry.

It will enroll up to 600 patients at about 100 U.S. clinical sites, with the first enrollment anticipated later this year. Follow-up assessments will take place after 30 days, six months, and 12 months post-procedure to evaluate safety and effectiveness of outcomes.

“This registry will provide valuable data to support clinical decision-making and enhance patient outcomes in the management of PAD,” said Dr. Krishnan. “The Rotarex System has been extensively studied internationally, and we are excited to further evaluate its adaptability in treating a wide range of PAD lesions within the U.S. patient population.”

“The XTRACT Registry is the first comprehensive registry aimed at providing key insights into the real-world applications of the Rotarex System,” added Rima Alameddine, worldwide president of BD Interventional-Peripheral Intervention. “This study underscores our unwavering commitment to optimizing treatment strategies in partnership with leading physicians to improve patient care.”