Becton, Dickinson and Company (BD) is set to initiate a multi-centre registry study, XTRACT, of the Rotarex Atherectomy System, aimed at measuring real-world outcomes for individuals with peripheral artery disease (PAD).
The prospective, single-arm registry is a post-market study that will evaluate the system’s clinical performance in treating PAD lesions in US patients.
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It is a collaborative effort, led by co-principal investigators, interventional cardiologist Dr Prakash Krishnan and vascular surgeon Dr Todd Berland.
The registry plans to enrol up to 600 subjects at nearly 100 US clinical sites, with the enrolment of the first subject anticipated later this year.
Subjects in the registry will undergo clinical follow-up assessments after 30 days, six months, and 12 months after the procedure.
These evaluations will help determine the effectiveness and safety of the system.
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By GlobalDataRotarex is a minimally invasive solution tailored to remove the plaque and thrombus in peripheral arteries.
It functions as both a thrombectomy and atherectomy device, making it a suitable solution for PAD treatment.
According to the company, PAD is a common yet potentially debilitating condition, affecting over 21 million Americans and more than 200 million individuals worldwide.
It can result in an elevated risk of lower limb amputation and cardiovascular complications.
BD Interventional-Peripheral Intervention worldwide president Rima Alameddine said: “The XTRACT Registry is the first comprehensive registry aimed at providing key insights into the real-world applications of the Rotarex system.
“This study underscores our unwavering commitment to optimising treatment strategies in partnership with leading physicians to improve patient care.”
This initiative follows the company’s recent achievement of receiving the US Food and Drug Administration’s 510(k) clearance for the Phasix ST Umbilical Hernia Patch, which is now set for commercial launch.
