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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 RotarexTM 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.
Posted In: BDX
