BD Achieves Milestone with First Patient in XTRACT Registry for Rotarex Catheter in PAD Treatment

BD Reaches Important Milestone in Peripheral Artery Disease Research

BD (Becton, Dickinson and Company) has marked a significant achievement in the realm of healthcare by enrolling the first patient in the XTRACT™ Registry, a vital study aimed at gathering real-world evidence on the efficacy of the Rotarex™ Catheter System for patients suffering from peripheral artery disease (PAD). This milestone was officially announced on October 9, 2025, and reflects BD's ongoing commitment to advancing medical research and improving patient outcomes.

Overview of the XTRACT™ Registry

The XTRACT™ Registry is a prospective, multi-center, single-arm post-market study designed specifically to assess the performance of the Rotarex™ Catheter System in treating PAD lesions. It aims to collect extensive data that will be invaluable for healthcare providers as they make clinical decisions about patient care. The involvement of acknowledged experts in the field, such as Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon, underscores the study's significance. The first patient was enrolled on September 29, 2025, under Dr. Kousta Foteh, who is the Chief of Vascular Surgery at the Vital Heart & Vein medical practice.

Importance of Patient Participation

Patient involvement in this registry is crucial, as it allows for the collection of real-world data that will guide clinical decision-making and help shape effective treatment strategies for PAD. Dr. Kousta Foteh expressed pride in being the first site to enroll a patient, emphasizing that the registry will yield essential evidence on the Rotarex™ Catheter System for enhancing treatment outcomes. The enrolled patient was dealing with a significantly occluded artery, and the Rotarex™ Catheter effectively removed the plaque, which led to a favorable result through a pedal approach.

Study Goals and Expectations

The XTRACT™ Registry has plans to recruit up to 600 patients across approximately 100 clinical sites in the United States. Participants will be assessed at three key follow-up points: 30 days, six months, and 12 months post-procedure. This comprehensive follow-up process is designed to measure both the safety and effectiveness of the Rotarex™ Catheter System in real-world clinical settings. Rob Righi, Vice President and General Manager of the Vascular Platform at BD Interventional—Peripheral Intervention, highlighted the importance of this initial enrollment, viewing it as a pivotal step toward generating substantial real-world evidence.

The Rotarex™ Catheter System

The Rotarex™ Catheter System stands out due to its innovative design that facilitates the removal of both plaque and thrombus through three distinct mechanisms. This dual functionality allows it to perform as an atherectomy and a thrombectomy device, effectively addressing various PAD lesions. The catheter's rotating atraumatic head modifies and detaches mixed morphology lesions, achieving enhanced lumen gain via the vortex created by the rotating cylinder, along with continuous negative pressure that actively aspirates material away from the treated area.

The Impact of PAD

Peripheral artery disease is a significant health concern, affecting more than 21 million individuals in the United States alone and over 200 million globally. Left untreated, PAD can lead to severe complications, including cardiovascular events and lower limb amputations. The findings from the XTRACT™ Registry will contribute significantly to understanding the impact of treatment options on patient outcomes, reflecting BD's dedication to fostering evidence-based research in the medical community.

Conclusion

As BD moves forward with the XTRACT™ Registry, the company continues to reinforce its position as a leader in medical technology by harnessing innovative solutions that not only improve clinical outcomes but also enhance the overall quality of healthcare delivery. The milestone of enrolling the first patient is just the beginning of a promising journey towards improving treatment strategies for patients suffering from peripheral artery disease. Continued collaboration with healthcare professionals will be essential in translating these insights into impactful clinical practices, thereby advancing care for all affected individuals.

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