AngioDynamics Launches AMBITION BTK Trial to Improve Treatment for Critical Limb Ischemia
- AngioDynamics initiates the AMBITION BTK trial to evaluate the Auryon Atherectomy System's efficacy for critical limb ischemia treatment.
- The trial will enroll up to 200 participants across 30 sites, with a companion registry tracking 1,500 additional patients.
- AngioDynamics aims to enhance treatment options for vascular diseases and improve patient outcomes amid rising diabetes-related health challenges.
AngioDynamics Embarks on Groundbreaking AMBITION BTK Trial to Combat Critical Limb Ischemia
AngioDynamics, Inc., a leading medical technology company dedicated to improving vascular health, announces the initiation of its multicenter, randomized controlled trial (RCT), AMBITION BTK. The study aims to evaluate the clinical efficacy of the Auryon Atherectomy System, utilized in conjunction with standard balloon angioplasty, against balloon angioplasty alone for treating infrapopliteal lesions in patients suffering from critical limb ischemia (CLI). This significant trial will enroll up to 200 participants across approximately 30 hospital sites, while a companion registry will track an additional 1,500 patients treated with the Auryon system who do not meet RCT eligibility criteria.
Critical limb ischemia, a severe manifestation of lower extremity peripheral artery disease (PAD), affects over 230 million adults globally and often results in lower extremity amputation. Juan Carlos Serna, Senior Vice President of Scientific and Clinical Affairs at AngioDynamics, underscores the company's commitment to enhancing treatment options for complex below-the-knee lesions. The Auryon laser system, already deployed in over 100,000 procedures worldwide, has demonstrated its capacity to address various infrainguinal lesion types, including below-the-knee and in-stent restenosis, making it a vital tool in managing CLI.
Co-Principal Investigator Dr. Anahita Dua emphasizes the rising prevalence of severe tibial disease, largely driven by increasing diabetes rates, which limits available treatment options in the U.S. Traditional methods often fall short for patients with below-the-knee lesions. The AMBITION BTK trial signifies a pivotal advancement in evaluating the Auryon Atherectomy System’s potential to substantially enhance patient care by restoring laminar blood flow in affected vessels, thereby improving clinical outcomes for this high-risk patient population.
In parallel with the clinical trial, AngioDynamics continues to focus on expanding its innovative solutions to address growing health challenges associated with PAD. By prioritizing research and development in this area, the company aims to solidify its position as a leader in vascular technologies and improve the quality of life for patients affected by severe vascular conditions.
The AMBITION BTK trial not only reflects AngioDynamics' dedication to advancing treatment methodologies but also showcases its commitment to tackling widespread health issues linked to vascular diseases. The ongoing research reinforces the urgency of improving treatment options for critical limb ischemia as the global burden of diabetes and its associated complications continues to rise.