Cardiovascular Systems has announced that the US FDA has granted 510(k) clearance for the OrbusNeich 1mm Sapphire II PRO coronary balloon. The approval means that the device is the first and only 1mm coronary balloon available in the USA. In January, CSI announced it is the exclusive US distributor of OrbusNeich balloon products.
At launch, CSI will offer both the 1–4mm Sapphire II PRO and the 2–4 mm Sapphire NC Plus non-compliant coronary balloons on a limited basis. The company anticipates that OrbusNeich’s full balloon product portfolio will become available in the USA throughout 2018 and 2019.
David E Kandzari (Piedmont Heart Institute, Atlanta, USA) principal investigator for the Sapphire II PRO US clinical study, says: “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. 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.”
Scott Ward, CSI’s Chairman, President and Chief Executive Officer, notes: “Offering the Sapphire II PRO 1.0mm coronary balloon—the smallest, FDA-cleared coronary balloon on the market—is critical for physicians treating highly complex coronary lesions. As the market leader in coronary atherectomy, the 1mm balloon complements our orbital atherectomy system as we continue providing advanced solutions for treating the complex and high-risk indicated patient.”