Accurate modeling of normal anatomy as well as of morphologic changes caused by disease is crucial to defining the conditions under which medical devices should be tested. Each of us is unique, and so are the diseases and disease states that inflict morphologic changes upon us. These morphologic changes have the potential to reduce a patient’s quality of life and may lead to death. In addition, they complicate researchers’ attempts to create accurate and useful anatomic models. The ability to accurately mimic anatomy as well as altered anatomy caused by disease can greatly augment the current standards for medical device testing.
At MED Institute, we partner with physicians who practice medicine in targeted disease areas. The physicians’ experience and expertise, in combination with imaging data that represent various normal and diseased anatomies, allow us to overcome many of the challenges of anatomic modeling, providing the ability to create accurate anatomic models.
Here are a few of the challenges in creating accurate anatomic models:
MED has a successful history of developing anatomic models and boundary conditions for a number of locations around the body. We work with our customers to determine the appropriate natural variations for the intended patient population. Given that most diseases are progressive, we partner with experienced physicians to understand the stages of the disease. This understanding and our experience with a broad imaging data set allow us to choose the most appropriate anatomical model in which to test new devices. Evaluating the interactions of medical devices with the most realistic anatomic model possible is critical and something we do well.
Bench testing and animal testing of medical devices and therapies help us gain a better understanding of device deployment, durability, and function over time. These efforts allow a better understanding of device performance, treatment effect and importantly, failure modes. The use of detailed and realistic human anatomic models in these tests can provide crucial information regarding:
An example of the value of accurate modeling is found in studies of minimally invasive treatments for aneurysms involving cerebral arteries.
A cerebral artery aneurysm can lower a patient’s quality of life significantly and will likely lead to death if untreated. Treating the disease with open surgery is dangerous and carries higher risks of comorbidities and death. A better option, if the anatomy allows, is a minimally invasive approach.
With minimally invasive techniques, devices such as wire guides and catheters can be used to negotiate the vasculature. Access vessels; the aortic arch and great vessels; the carotid arteries; the tortuous, bone-entombed cerebral arteries; and any existing calcified plaque along the entire arterial pathway are accessible to minimally invasive intervention.
An anatomic model that incorporates the various access vessels, the aortic arch and great vessel configurations, as well as inherent disease provides another step toward gaining information that is not only accurate but also helps provide a level of real- world experience prior to treating patients.
Accurate anatomic modeling can provide the necessary information to allow continued innovation to bring to market disruptive devices and therapies that help improve patients’ quality of life and save lives. At MED Institute, we have the tools to help with any anatomic modeling needs. Contact us so that we can work together to make products and therapies that will improve patient outcomes.
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