BD Achieves Landmark Enrollment Milestone for XTRACT™ Study
BD Reaches Important Milestone with XTRACT™ Registry
BD (Becton, Dickinson and Company) (NYSE: BDX) has recently announced a significant achievement with the enrollment of the first patient in the XTRACT™ Registry. This milestone is a vital step in advancing the research surrounding the Rotarex™ Catheter System, specifically aimed at improving the treatment of patients with peripheral artery disease (PAD).
What is the XTRACT™ Registry?
The XTRACT™ Registry is a prospective, multi-center, single-arm registry study. Its primary objective is to evaluate the real-world performance of the Rotarex™ Catheter System as a treatment option for patients suffering from PAD lesions. Under the guidance of Co-Principal Investigators, Dr. Prakash Krishnan and Dr. Todd Berland, the registry aims to collect critical data that can inform treatment strategies and improve clinical decision-making.
Details of the First Enrollment
The first patient was successfully enrolled by Dr. Kousta Foteh, who leads the vascular surgery team at a reputable medical practice. This first enrollment is an encouraging indication of the registry's potential to yield valuable insights. The patient's condition involved a significantly occluded artery, which the Rotarex™ Catheter skillfully addressed, demonstrating the device’s effectiveness.
Future of the XTRACT™ Registry
As the registry progresses, it is expected to expand to include up to six hundred patients across around one hundred clinical sites throughout the country. These patients will undergo comprehensive follow-up assessments at key intervals: 30 days, 6 months, and 12 months post-treatment. This structured evaluation will help to solidify the safety and efficiency of the Rotarex™ Catheter in real-world medical practice.
"Enrolling our first patient is a significant progression in our commitment to generating impactful real-world evidence with the Rotarex™ Catheter System," stated Rob Righi, Vice President and General Manager of the Vascular Platform at BD Interventional–Peripheral Intervention. He expressed excitement about gathering further clinical insights that will facilitate the enhancement of patient care relating to PAD.
Understanding Peripheral Artery Disease
PAD is a prevalent condition impacting over 21 million individuals in the United States and a staggering over 200 million globally. As a circulatory problem, this disease can give rise to serious complications, including an elevated risk of cardiovascular issues and potential amputations if left untreated. The aim of the XTRACT™ Registry is to confront these challenges by backing evidence-based research while introducing innovative technologies to enhance treatment outcomes.
Innovations in Technology
The Rotarex™ Catheter System features a sophisticated mechanism that effectively tackles both plaque and thrombus, making it a versatile option for various PAD lesions. Its dual functionality serves as both an atherectomy and thrombectomy device, employing a unique rotating head that modifies and detaches complex lesions. This system capitalizes on a vortex created during operation, which augments luminal gain while actively aspirating and transporting material away from the treated area.
BD's Commitment to Healthcare
BD is recognized as one of the largest global medical technology firms, striving to elevate healthcare standards worldwide through innovative solutions. The organization dedicates itself to supporting healthcare professionals by crafting advanced technologies and services, continuously improving both patient therapies and clinical processes. With a passionate workforce exceeding 70,000, BD collaborates extensively with partners across the globe to tackle some of the most pressing health challenges facing communities today.
Frequently Asked Questions
What is the primary goal of the XTRACT™ Registry?
The XTRACT™ Registry aims to evaluate the real-world performance of the Rotarex™ Catheter System for treating peripheral artery disease.
How many patients are expected to be enrolled in the XTRACT™ study?
Up to six hundred patients will be involved, drawn from around one hundred clinical sites across the United States.
What are the follow-up evaluation periods for patients in the registry?
Patients will have follow-up evaluations at 30 days, six months, and 12 months after their procedure.
Who are the principal investigators leading the XTRACT™ Registry?
The registry is co-led by Dr. Prakash Krishnan and Dr. Todd Berland, both experienced in their respective fields of interventional cardiology and vascular surgery.
What makes the Rotarex™ Catheter System innovative?
The Rotarex™ Catheter System features a design that removes both plaque and thrombus efficiently, utilizing a unique mechanism that enhances treatment effectiveness for PAD lesions.
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