BD Launches Patient Data Registry for PAD Treatment
BD (Becton, Dickinson and Company) (NYSE: BDX), a prominent global leader in medical technology, has announced an exciting initiative to launch a patient data registry specifically for the Rotarex™ Atherectomy System. This registry aims to measure real-world outcomes for patients living with peripheral artery disease (PAD).
Purpose of the XTRACT Registry
Known as 'XTRACT,' this prospective, multi-center, single-arm, post-market registry study is designed to evaluate the clinical performance of the Rotarex™ Atherectomy System in treating patients with PAD lesions. This significant effort is in partnership with esteemed Co-Principal Investigators, Dr. Prakash Krishnan, a renowned interventional cardiologist, and Dr. Todd Berland, a respected vascular surgeon.
Enrollment and Evaluation Process
The XTRACT Registry plans to enroll up to 600 patients at around 100 clinical sites. With the first patient expected to enroll in this essential study later this year, clinical follow-up assessments will be conducted at intervals of 30 days, 6 months, and 12 months post-procedure to thoroughly evaluate safety and effectiveness of the treatment outcomes.
Enhancing Patient Care
Dr. Krishnan remarked, 'This registry will provide valuable data to support clinical decision-making and enhance patient outcomes in the management of PAD.' He acknowledges the extensive international studies conducted on the Rotarex™ System and expresses excitement about assessing its adaptability across various PAD lesions in the U.S. patient population.
The Rotarex™ Atherectomy System Explained
The Rotarex™ Atherectomy System is designed as a minimally invasive device that adeptly removes both plaque and thrombus from peripheral arteries. Notably, it offers dual functionality, serving both as an atherectomy and a thrombectomy device, making it a crucial tool in the current medical landscape for treating PAD.
Commitment to Patient Outcomes
Rima Alameddine, worldwide president of BD Interventional-Peripheral Intervention, stated, 'The XTRACT Registry represents the first comprehensive registry aimed at unveiling insights into the practical applications of the Rotarex™ System.' This initiative highlights BD’s commitment to improving treatment strategies by collaborating closely with leading physicians to enhance patient care and outcomes.
The Importance of Addressing PAD
Peripheral artery disease is a serious condition affecting over 21 million individuals in the U.S. and over 200 million globally. PAD can lead to severe complications, including cardiovascular risks and lower limb amputations. The XTRACT Registry showcases BD's sustained commitment to innovative technological development and evidence-based research aimed at supporting healthcare professionals while improving patient outcomes.
About BD
BD is among the largest global medical technology firms, leading advancements in health through enhanced medical discovery, diagnostics, and care delivery. BD passionately supports healthcare heroes by developing innovative technologies, services, and solutions that boost clinical therapy and processes for health providers. With more than 70,000 employees worldwide, BD collaborates closely with partners to tackle pressing global health challenges. The organization aims to enhance outcomes, lower costs, and improve access to healthcare on a global scale. For further information about BD, please visit bd.com or connect on LinkedIn, X (formerly Twitter), and Instagram.
Frequently Asked Questions
1. What is the purpose of the XTRACT Registry?
The XTRACT Registry aims to assess the clinical performance of the Rotarex™ Atherectomy System in treating patients with peripheral artery disease.
2. Who are the Co-Principal Investigators for the registry?
The registry is led by Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon.
3. How many patients will be enrolled in the XTRACT Registry?
Up to 600 patients will be enrolled across approximately 100 clinical sites.
4. When is the expected first patient enrollment for the registry?
The first patient enrollment is anticipated to occur later this year.
5. What is peripheral artery disease (PAD)?
PAD is a serious condition that affects over 21 million people in the U.S. and can lead to significant complications, including cardiovascular issues and amputations.
