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BD Launches the XTRACT Registry for Rotarex™ Atherectomy System

BD (Becton, Dickinson and Company), a prominent player in the global medical technology field, has revealed plans to implement a significant patient data registry focused on its Rotarex™ Atherectomy System. This initiative is specifically targeted at evaluating the real-world efficacy and safety outcomes associated with treating patients suffering from peripheral artery disease (PAD). This disease affects millions worldwide and is a leading cause of cardiovascular complications.

Introducing the XTRACT Registry

The newly announced XTRACT Registry is a multi-center, single-arm study that seeks to capture comprehensive clinical data about the effectiveness of the Rotarex™ system in PAD patients across the United States. Under the expert guidance of Co-Principal Investigators Dr. Prakash Krishnan and Dr. Todd Berland, the registry is set to enroll as many as 600 patients across approximately 100 clinical sites, beginning with the first enrollment expected to take place later this year.

This registry is a major step as it is the first comprehensive analysis specifically aimed at assessing the clinical performance of the Rotarex™ Atherectomy System in the U.S. patient population, highlighting BD's commitment to improving treatment for those diagnosed with PAD.

Importance of PAD and Goals of the Registry

Peripheral artery disease is a condition characterized by narrowed arteries, reducing blood flow to the limbs. It is often associated with various cardiovascular risks, including heart attacks and strokes. Unfortunately, PAD often remains underdiagnosed and undertreated, leading to serious health consequences such as lower limb amputation.

The XTRACT Registry aims to collect valuable data that physicians can utilize to enhance treatment strategies, potentially leading to improved patient outcomes. According to Dr. Krishnan, understanding the real-world application of the Rotarex™ technology can significantly influence clinical decision-making, ultimately benefiting patients who rely on such innovative treatment options.

The Rotarex™ Atherectomy System

Notably, the Rotarex™ Atherectomy System is designed for minimally invasive use, enabling the effective removal of both plaque and thrombus in peripheral arteries. Its dual capability as both an atherectomy and thrombectomy device positions it as a vital instrument for addressing the complexities of peripheral artery disease.

Rima Alameddine, worldwide president of BD Interventional-Peripheral Intervention, emphasized that this registry reflects BD’s unwavering dedication to optimizing treatment methods in collaboration with leading healthcare professionals. “We are thrilled to advance our understanding of how the Rotarex™ System can be utilized in various PAD cases across diverse patient demographics in the U.S.,” she stated.

Looking Forward

As BD proceeds with the XTRACT Registry, it remains focused on its core commitment to fostering innovative technological advancements and conducting evidence-based research. With more than 21 million Americans suffering from peripheral artery disease, this registry represents a pivotal evolution in the clinical landscape, aiming to deliver improved care and reduced complications for a vast patient population.

BD is recognized for its leadership in the medical technology arena, advancing healthcare through innovative solutions that enhance clinical outcomes. With its extensive resources and commitment to improvement, BD stands poised to address pressing global health challenges and refine the treatment landscape for patients with peripheral artery disease.

For ongoing updates on this transformative initiative, healthcare providers and interested stakeholders can follow BD via its official platforms and stay connected with advancements in cardiovascular health care technologies.