Technology | Balloon Catheter | March 21, 2018

Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance of Sapphire II Pro 1mm Coronary Balloon

Device is the smallest 510(k)-cleared coronary balloon in the U.S. market

Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance  of Sapphire II Pro 1mm Coronary Balloon

March 21, 2018 — Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich 1mm Sapphire II Pro coronary balloon.

The Sapphire II Pro, the first and only 1mm coronary balloon available in the U.S., offers industry-leading entry and crossing profiles, according to the company, and is precision engineered for crossing and treating extremely tight and complex lesions.

In January, CSI announced it is the exclusive U.S. distributor of OrbusNeich balloon products. OrbusNeich is a globally recognized corporation with established balloon technologies in both percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

“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,” according to David E. Kandzari, M.D., director of interventional cardiology and chief scientific officer, Piedmont Heart Institute, Atlanta, and principal investigator for 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.”

At launch, CSI will offer both the 1-4mm Sapphire II Pro and the 2-4mm 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 U.S. throughout 2018 and 2019.

For more information: www.orbusneich.com

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