BD (NYSE: BDX) today announced the enrollment of the first patient in the XTRACT Registry for its Rotarex catheter system.
The prospective, multi-center, single-arm, post-market registry evaluates Rotarex’s real-world performance in treating patients with peripheral artery disease (PAD) lesions.
Franklin Lakes, New Jersey-based BD — one of the largest medtech companies in the world — announced plans for the registry earlier this year. It expects to enroll up to 600 patients across about 100 clinical sites in the U.S. The study has planned follow-up after 30 days, six months and 12 months post-procedure to evaluate safety and effectiveness.
Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon, lead XTRACT as co-principal investigators. Dr. Kousta Foteh, chief of vascular surgery at Vital Heart & Vein, enrolled the first patient on Sept. 29.
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“We are proud to be the first site to enroll a patient in the XTRACT Registry,” said 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.”
Rotarex, a minimally invasive solution, removes both plaque and thrombus in peripheral arteries. It has dual indications as both an atherectomy and thrombectomy device in treating PAD. The catheter uses three distinct mechanisms of action for effectiveness in various PAD lesions in peripheral arteries.
BD says its rotating atraumatic catheter head has blunt facets to modify and detach mixed morphology lesions. A vortex created around the system’s rotating cylinder helps to achieve additional luminal gain. Then, the catheter’s rotating internal helix creates continuous negative pressure at the tip. This actively aspirates and transports 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 GM 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.”
