OrbusNeich won FDA clearance for the OrbusNeich 1.0mm Sapphire II PRO coronary balloon, the only coronary balloon of such small size available in the U.S. It’s designed for dealing with the tightest and most difficult to treat lesions, capable of moving through tortuous vasculature and crossing through compacted plaques.
“As physicians, we have continued to advance techniques and expand access to interventional cardiology procedures. As a result, the patients we are treating today have become increasingly complex, with more challenging lesions and anatomy, and with more difficult clinical indications,” in a statement said David E. Kandzari, M.D., Director of Interventional Cardiology and Chief Scientific Officer, Piedmont Heart Institute, and leader of the Sapphire II PRO U.S. Clinical Study. “With its exceptionally low profile and deliverability, the Sapphire II PRO is an important new tool to enable us to better treat the patients we serve.”
Product page: Sapphire II PRO…
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