BD (Becton, Dickinson and Company) has launched a real-world patient data registry for the Rotarex Atherectomy System to evaluate patients with peripheral artery disease (PAD).
The study, dubbed XTRACT, will focus on assessing the clinical performance of the system in treating PAD lesions in US patients.
The XTRACT Registry is a prospective, multi-centre, single-arm, post-market study.
It will be conducted in partnership with Co-Principal Investigators, Dr Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon.
The study plans to enrol up to 600 patients across approximately 100 clinical sites in the United States, with initial patient enrolment expected later this year.
Clinical follow-up evaluations will be carried out at 30 days, six months, and 12 months post-procedure to assess the safety and effectiveness of the outcomes.
Krishnan said: “This registry will provide valuable data to support clinical decision-making and enhance patient outcomes in the management of PAD.
“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 US patient population.”
The Rotarex atherectomy system is a minimally invasive device designed to remove plaque and thrombus from peripheral arteries.
The system offers dual indications as both an atherectomy and a thrombectomy device.
PAD is a serious condition affecting over 21 million Americans and more than 200 million people worldwide.
It can lead to increased risks of cardiovascular complications and lower limb amputation.
BD Interventional-Peripheral Intervention worldwide president Rima Alameddine said: “The XTRACT Registry is the first comprehensive registry aimed at providing key insights into the real-world applications of the Rotarex System.
“This study underscores our unwavering commitment to optimising treatment strategies in partnership with leading physicians to improve patient care.”
Last month, BD launched an investigational device exemption (IDE) study of GalaFLEX LITE Scaffold in treating capsular contracture (CC) during breast implant revision surgery.
The randomised, controlled, multi-centre trial, dubbed STANCE, aims to support BD’s Premarket Approval (PMA) application with the US Food and Drug Administration (FDA).
The STANCE study is designed to compare revision surgery outcomes in patients with implant-based breast augmentation using the scaffold versus conventional revision surgery.
