BD Reaches Major Milestone for Rotarex™ Catheter System with First Patient Enrolled in XTRACT™ Registry to Advance Real-World Evidence in Peripheral Artery Disease

Rhea-AI Summary

BD (NYSE: BDX) announced enrollment of the first patient in the XTRACT™ Registry on September 29, 2025, a prospective, multi-center, single-arm post-market study to evaluate real-world performance of the Rotarex™ Catheter System for peripheral artery disease (PAD).

The registry plans up to 600 patients across as many as 100 U.S. sites with follow-ups at 30 days, 6 months, and 12 months to assess safety and effectiveness. The Rotarex catheter offers combined atherectomy and thrombectomy mechanisms to remove plaque and thrombus. BD said the registry will generate real-world evidence to inform clinical decision-making and treatment strategies for PAD.

Positive

• First patient enrolled on Sept 29, 2025
• Planned enrollment of up to 600 patients
• Up to 100 U.S. clinical sites expected
• Systematic follow-up at 30 days, 6 months, 12 months
• Device has dual atherectomy and thrombectomy functionality

Negative

• Single-arm registry limits comparative effectiveness conclusions

Insights

Clinical Evidence Strategist

BD enrolled the first patient into the XTRACT™ Registry to collect real‑world data on the Rotarex™ Catheter System.

BD's enrollment of the first patient on September 29, 2025 begins a prospective, single‑arm post‑market registry intended to capture safety and effectiveness outcomes for the Rotarex™ Catheter System across up to 100 U.S. sites and as many as 600 patients. The device combines atherectomy and thrombectomy mechanisms to remove mixed plaque and thrombus; initial case notes a lesion > 70% occlusion treated via a pedal approach.

Key dependencies include site activation pace, patient follow‑up completeness at 30 days, six months, and 12 months, and consistent outcome definitions across centers. Registry data quality will hinge on procedural standardization and adjudication of events; early enrollment by experienced operators reduces procedural variability but does not substitute for controlled comparative evidence.

Watch for enrollment milestones and core endpoint reports at the 12‑month follow‑up horizon, plus interim safety signals at 30 days. These registry results should inform clinical practice patterns and reimbursement discussions if they demonstrate consistent, generalizable safety and effectiveness across the planned multisite cohort.

FRANKLIN LAKES, N.J., Oct. 9, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the enrollment of the first patient in the XTRACT™ Registry, a prospective, multi-center, single-arm, post-market registry study designed to evaluate the real-world performance of the Rotarex™ Catheter System in the treatment of patients with peripheral artery disease (PAD) lesions.

The XTRACT™ Registry is being led in partnership with Co-Principal Investigators, Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon. The first patient was enrolled on September 29, 2025, under the care of Dr. Kousta Foteh, Chief of Vascular Surgery at Vital Heart & Vein medical practice. With patient participation, the XTRACT™ Registry will now collect valuable data to inform clinical decision-making and optimize treatment strategies for PAD.

"We are proud to be the first site to enroll a patient in the XTRACT™ Registry," said Dr. Foteh. "This registry will provide critical real-world evidence on the Rotarex™ Catheter System and help physicians refine treatment strategies to improve outcomes for patients with PAD. This first case is similar to what we commonly see in our clinic, where an artery is more than 70% occluded. The versatile Rotarex^TM Catheter removed the debilitating plaque via pedal approach, delivering a favorable result for this patient."

The XTRACT™ Registry is expected to enroll up to six hundred patients in as many as one hundred clinical sites in the United States. Patients will undergo follow-up evaluations at 30 days, six months, and 12 months post-procedure to assess both safety and effectiveness of the Rotarex™ Catheter System in everyday clinical practice.

"The enrollment of our first patient marks a significant milestone in our mission to generate robust, real-world evidence supporting the Rotarex™ Catheter System," said Rob Righi, vice president and general manager of the Vascular Platform at BD Interventional–Peripheral Intervention. "We are excited to begin gathering these additional clinical insights that will help physicians enhance patient outcomes and advance PAD care, and we look forward to building on this landmark initial enrollment."

The Rotarex™ Catheter System is designed to efficiently remove both plaque and thrombus by using three distinct mechanisms of action, making it an effective treatment for various PAD lesions in peripheral arteries. Offering dual functionality as both an atherectomy and thrombectomy device, the rotating atraumatic catheter head with blunt facets modifies and detaches mixed morphology lesions. Additional luminal gain is achieved by a vortex created around the rotating cylinder. The rotating internal helix creates continuous negative pressure at the tip, actively aspirating and transporting material away.

PAD affects more than 21 million Americans¹ and over 200 million people worldwide.² Left untreated, it can lead to increased risk of cardiovascular complications and lower limb amputation.^1,2 The XTRACT™ Registry reflects the continued commitment of BD to advancing evidence-based research and delivering innovative technologies that improve outcomes for patients.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiency, improve safety, and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson. 

Contacts:
Media:	Investors:
Fallon McLoughlin	Adam Reiffe
Director, Public Relations	Sr. Director, Investor Relations
201.258.0361	201.847.6927
fallon.mcloughlin@bd.com	adam.reiffe@bd.com

 

¹ Yost M. The current U.S. prevalence of peripheral arterial disease. Vasc Dis Manag. 2023;20(4): E67-E73.
² Allison MA, Armstrong DG, Goodney PP, et al. Health disparities in peripheral artery disease: A scientific statement from the American Heart Association. Circulation. 2023;148(3):286-296. doi:10.1161/CIR.0000000000001153.

BD, the BD Logo, Rotarex, and XTRACT are trademarks of Becton, Dickinson and Company or its affiliates. © 2025 BD. All Rights Reserved. BD-162804

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SOURCE BD (Becton, Dickinson and Company)

FAQ

When was the first patient enrolled in the XTRACT Registry for BDX Rotarex?

The first patient was enrolled on September 29, 2025.

How many patients will the BDX XTRACT Registry enroll and where?

The registry plans to enroll up to 600 patients across as many as 100 U.S. sites.

What follow-up schedule does the XTRACT Registry use for Rotarex (BDX)?

Patients will be evaluated at 30 days, 6 months, and 12 months post-procedure.

What clinical functions does the Rotarex Catheter System (BDX) provide?

Rotarex offers combined atherectomy and thrombectomy actions to remove plaque and thrombus.

Who are the lead investigators for the XTRACT Registry enrolling Rotarex (BDX)?

The registry is led by Co-Principal Investigators Dr. Prakash Krishnan and Dr. Todd Berland.

Will the XTRACT Registry provide randomized comparative data for Rotarex (BDX)?

No; the study is a single-arm post-market registry, so it does not include randomized comparative arms.