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Call for Comments on Petition for Testing Nitinol

The following information was provided by MD&DI contributing author, Ryszard Rokicki, owner of Electrobright (Macungie, PA). "Despite continuous research to improve nitinol properties it is still impossible to produce 100% homogenous, intermetallic inclusion free nitinol," says Rokicki. "The best that nitinol producers came to until now is what is termed extra low inclusion nitinol.

The nitinol inclusions, especially those that leave residue on the surface of finished implantable devices (e.g., stents) are the main culprits of stent fracture, nickel leaching that leads to allergies,  restenosis, and stent thrombosis. Up until this point is has been impossible to test efficiently stent for inclusions." "However," he says, "a newly developed inclusion detection test has provided a way to efficiently test every single nitinol stent before implantation. On the basis of this test, a citizen petition was filed with FDA, requesting the test's implementation." To view and comment on the petition, please visit Under  "Enter Keyword or ID", type the petition docket number: 2009-P-0362 and click  on the "Search" button.

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