Although our Labeling precludes us from promotion for any particular indication, we encourage you to explore the numerous articles available on the world wide web.
Our devices are widely accepted and requested by Physicians that are interested in having a trusted system for delivering an invisible gas.
Our products are Class I Devices and are exempt from pre-market notification and 510K approval.
Exempted Devices Some medical devices are sufficiently well-known—and their safety and effectiveness are sufficiently well characterized and established—that they require no premarket review by the Agency.
They are still subject to a general regulations that require proper labeling, manufacture, and investigation of adverse events. As of the end of calendar 2008, FDA’s Center for Devices and Radiological Health had exempted about 800 devices. The vast majority are designated as Class I devices, and a small number are Class II.
The products are reimbursed by billing the code applicable to the procedure being performed. There are no codes specific to these products.
The useful life of the CO2mmander® ELITE would be no less than 2 years.
The shelf life of the AngiAssist® is 2-3 years, based on the package expiration date.
There are no specific requirements in the storage of the products, aside from normal room temperature.
The uses described in the information and links below have not been approved or cleared by FDA, as applicable to the described drug or medical device.
FDA does recognize, however, the important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities.
AngioAdvancements has an interest in the Co2mmander and AngiAssist that are mentioned in some of these journal reprints or reference text. Authors, Walker and Caridi, are known to the manufacturer as having an interest in the products as they serve as Medical Experts for the Company and were chosen due to their previous experience with the subject matter.
To the extent that the recipients of this information have questions, our Sales Representative have been instructed to refer such questions to our medical/scientific officer or department.
The officer or department to which the referral is made is separate from our Sales and/or Marketing Departments.
Physicians can use CO2 with more confidence due to technological advancements and improved methods of safe delivery. Extensive training of the uses of CO2 to improve patient care is warranted as physicians seek to provide the highest quality of care in the most economical environment. This educational activity will address the unique and complicated health care needs of those with renal insufficiency and allergy to iodinated contrast as well of the many disease entities where typical liquid contrast fails in the diagnosis and/or treatment.
The CO2 Angiography Society is multispecialty organization dedicated to the virtues of intravascular CO2 to diagnose and intervene while preserving renal function.
We welcome all healthcare providers to learn more about the unique and complicated health care needs of those with renal insufficiency and allergy to iodinated contrast as well of the many disease entities where typical liquid contrast fails in the diagnosis and/or treatment.