At AngioDynamics, we provide tools and solutions to address some of the most critical and prevalent disease states. Through the initiation of clinical studies and development of innovative technologies, we contribute our best each and every day to meet the needs of patients and their healthcare providers.
Going Beyond Procedures
At AngioDynamics, we provide tools and solutions to address some of the most critical and prevalent disease states. Through the initiation of clinical studies and development of innovative technologies, we contribute our best each and every day to meet the needs of patients and their healthcare providers.
Educating Healthcare Providers
Master Courses
Providing world-class education and peer-to-peer collaboration for physicians using our technologies to deliver a better care experience.
Generating Data
Clinical studies intended to prove efficacy and safety of a medical device require rigorous and meticulous processes. AngioDynamics is experienced and trusted by numerous industry associations, hospitals and medical professionals who work collaboratively through the study process – ultimately helping to bring innovative solutions to market for better patient care. The following details the necessary steps to complete a study.
Study Approval
For clinical studies involving investigational devices, the U.S. Food and Drug Administration (FDA) grants an Investigational Device Exemption (IDE), allowing the use of a medical device in research. IDE approval is a critical regulatory step in the process of evaluating new medical devices through clinical research to ensure that the device is tested in a controlled and ethical manner. Additionally, studies involving human participants may require formal authorization by an Institutional Review Board (IRB) when involving human participants. IRB approval is required to ensure the study meets ethical standards and regulatory requirements for protecting participants.
Enrolling
Following IDE Approval is recruitment, in which participants who meet eligibility requirements are identified ensuring diverse representation to reflect real-world usage scenarios. Baseline assessment is then conducted along with division among the study participants between intervention and control groups to ensure study fairness and scientific accuracy.
Enrollment Complete
Next is Follow-up Data Collection and assessment according to the study protocol. Reporting and publication, specifically in peer-reviewed journals, are key to disseminating results to the medical community.
Study Complete
If a study demonstrates the device’s safety and efficacy, data is submitted to regulatory authorities to support market approval or clearance. Following that, there is ongoing surveillance of participants to ensure safety and efficacy in real-world settings.
APEX-AV was a prospective, single-arm, multi-center study that evaluated the safety and effectiveness of the AlphaVac F1885 MMA System for the treatment of acute pulmonary embolism.
Learn More About the APEX Study
The PATHFINDER Post-Market Registry was a multi-center, prospective, observational registry that collected data on patients with symptomatic Peripheral Artery Disease (PAD) who underwent atherectomy with the Auryon System.
Learn More About the PATHFINDER Study
The PRESERVE study, initiated by AngioDynamics, Inc. in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), is evaluating the use of the NanoKnife System as a focal therapy option for prostate cancer patients. It is assessing the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
Learn More About the PRESERVE Study
The RECOVER-AV Trial is a prospective, multicenter, multinational study evaluating the effectiveness and safety of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism (PE).
Learn More About the RECOVER-AV Study
The AMBITION BTK study is a randomized controlled trial of the Auryon Atherectomy System used in combination with standard Balloon angIoplasty versus standard balloon angioplasty alone in treating infrapopliteal lesions in subjects with Critical Limb Ischemia below-the-knee.
Learn More About the AMBITION-BTK StudyNanoKnife, Auryon, and AlphaVac are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary.