BD Begins Postmarket XTRACT Registry of Rotarex Catheter to Treat PAD

October 9, 2025—BD (Becton, Dickinson and Company) announced the enrollment of the first patient in the XTRACT registry, which is designed to assess the real-world performance of the company’s Rotarex catheter system in the treatment of peripheral artery disease (PAD) lesions. According to the company, the prospective, multicenter, single-arm, postmarket study will collect clinical data to inform practice and optimize treatment strategies for PAD.

The XTRACT registry aims to enroll up to 600 patients at up to 100 clinical sites across the United States with follow-up at 30 days, 6 months, and 12 months postprocedure to evaluate both safety and effectiveness of the Rotarex catheter system in routine practice, stated BD. The coprincipal investigators of the registry are interventional cardiologist Prakash Krishnan, MD, and vascular surgeon Todd Berland, MD.

The first patient in the registry was enrolled by Kousta Foteh, MD, Chief of Vascular Surgery at Vital Heart & Vein in Humble, Texas.

“We are proud to be the first site to enroll a patient in the XTRACT registry,” commented Dr. Foteh in BD’s press release. “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 catheter removed the debilitating plaque via pedal approach, delivering a favorable result for this patient.”

The company noted that the Rotarex catheter system uses three mechanisms of action to remove both plaque and thrombus: a rotating atraumatic catheter head with blunt facets that modifies and detaches mixed morphology lesions; a vortex that promotes luminal gain; and a rotating internal helix that creates continuous negative pressure for aspiration and removal of material.