St. Paul, Minn.-based Cardiovascular Systems touted the newly cleared product as the first and only 1mm coronary balloon available in the US.
“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 1.0mm balloon complements our orbital atherectomy system as we continue providing advanced solutions for treating the complex and high-risk indicated patient,” Cardiovascular Solutions prez & CEO Scott Ward said in a press release.
At launch, Cardiovascular Systems said it will offer both the 1-4mm Sapphire II Pro devices alongside the 2-4mm Sapphire NC Plus non-compliant coronary balloons on a limited basis. The company said it expects OrbusNeich’s full balloon portfolio to become available in the US through 2018 and 2019.
“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,” Sapphire II Pro study principal investigator Dr. David Kandzari of Atlanta, Ga.’s Piedmont Heart Institute said in a prepared statement.
In January, OrbusNeich inked a deal with Cardiovascular Systems that made it the exclusive US distributor of OrbusNeich balloon products.