Altura Medical is developing a percutaneous, low-profile endovascular stent-graft for the treatment of AAAs designed to eliminate some of the major issues associated with conventional endograft procedure safety, efficacy and complexity. The company's plan is to provide a flexible, off-the-shelf, ultra-low profile device with an industry-first 12 French inside diameter. The Altura system may be placed routinely in the cath lab as an outpatient procedure, and in more difficult AAA anatomies that are usually referred for open surgery, including those patients with short necks or smaller, tortuous iliac arteries.
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Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
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