BD [WtwhTicker symbol=”BDX”](NYSE: BDX)[/WtwhTicker] announced today that it plans to initiate a patient data registry for its Rotarex atherectomy system.
The registry aims to measure real-world outcomes for patients with peripheral artery disease (PAD). XTRACT, a multi-center, single-arm, post-market registry assesses Rotarex’s clinical performance in U.S. patients with PAD lesions.
Co-principal investigators Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon, lead XTRACT. They plan to enroll up to 600 patients across about 100 clinical sites in the U.S., kicking off enrollment later this year. The study has planned follow-up after 30 days, six months and 12 months post-procedure to evaluate safety and effectiveness.
“This registry will provide valuable data to support clinical decision-making and enhance patient outcomes in the management of PAD,” said 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.”
Rotarex, a minimally invasive solution, removes both plaque and thrombus in peripheral arteries. It has dual indications as both an atherectomy and thrombectomy device in treating PAD.
“The XTRACT Registry is the first comprehensive registry aimed at providing key insights into the real-world applications of the Rotarex™ System,” said 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.”
News of the registry comes months after BD issued a medical device correction letter related to the atherectomy system. The company identified a number of anatomical factors that could contribute to catheter helix fracture and/or breakage. It reported 30 serious injuries and four deaths associated with the issue.
