BD Enrolls 1st Patient in Rotarex Catheter Registry

BD (Becton, Dickinson and Company) has enrolled the first patient in the XTRACT Registry, a post-market registry study to evaluate the real-world performance of the Rotarex catheter system to treat peripheral artery disease (PAD) lesions.

The registry is expected to enroll up to six hundred patients in up to 100 clinical sites in the U.S. Patients will have follow-up evaluations at 30 days, six months, and 12 months post-procedure to evaluate Rotarex’s safety and effectiveness in everyday clinical practice.

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, under the care of Dr. Kousta Foteh, chief of vascular surgery at Vital Heart & Vein medical practice.

The registry will now collect data to inform clinical decision-making and optimize PAD treatment strategies.

“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 Catheter removed the debilitating plaque via pedal approach, delivering a favorable result for this patient.”

Thr Rotarex catheter system was designed to efficiently remove plaque and thrombus by using three distinct mechanisms of action. It has dual functionality as an atherectomy and thrombectomy device—a rotating atraumatic catheter head with blunt facets modifies and detaches mixed morphology lesions.

A vortex created around the rotating cylinder achieves further luminal fain. The rotating internal helix creates continuous negative pressure at the tip to actively aspirate and transport material away.

“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, VP 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.”

In August, the company submitted an application to the U.S. Food and Drug Administration (FDA) for a new, at-home human papillomavirus (HPV) test that enables patients to self-collect a sample in their own home using a Q-tip sized swab that simplifies lab processing and reports more high-risk HPV strains than other assays.