Cardiovascular Systems, Inc. has announced that the FDA has granted 510(k) clearance for the OrbusNeich 1.0mm Sapphire II PRO coronary balloon. OrbusNeich’s 1.0mm Sapphire II PRO, the first and only 1.0mm coronary balloon available in the U.S., offers industry-leading entry and crossing profiles and is precision engineered for crossing and treating extremely tight and complex lesions.

OrbusNeich has announced the launch of its world-renowned Sapphire PTCA balloon dilatation catheters following their recent 510k clearance by the FDA: the Sapphire II PRO and the Sapphire NC Plus. Specifically engineered for crossing the most difficult lesions and tracking tortuous anatomy, the Sapphire II Pro is tailored for successful dilatation. Its well-balanced sub-zero tapered tip has an ultra-low profile, providing effortles...