Medinol shares positive results in evaluation of EluNIR stent system
"The BIONICS data validated that the EluNIR stent performed very well in a more broad, less selected 'more comers' population than has previously been studied for most other DES," Dr. David Kandzari, director of Interventional Cardiology at Atlanta's Piedmont Heart Institute and principal investigator for the BIONICS trial, said. "These results establish the excellent clinical performance of this stent, and we look forward to seeing the angiographic data over the next few months to further support its efficacy."
Medinol’s study enrolled 1,919 patients from 76 sites in eight countries. The company released the results of the study at the Late Breaking Trial session of the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C. Medinol will now deliver the results to the Food and Drug Administration to achieve U.S. regulatory approval.
"The BIONICS data are consistent with the excellent results that were demonstrated by EluNIR in NIREUS," Dr. Yoram Richter, Medinol's chief scientific officer, said. "In the U.S. alone, over 700,000 patients undergo a coronary stenting procedure each year. We are excited to be able to provide them with a new treatment option that has proven outstanding clinical results."