FDA Clears One-Millimeter Coronary Balloon

Cardiovascular Systems Inc., a developer and commercializer of interventional treatment systems for patients with peripheral and coronary artery disease, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the OrbusNeich 1 mm Sapphire II PRO coronary balloon.
 
OrbusNeich’s 1 mm Sapphire II PRO, the first and only 1 mm coronary balloon available in the United States, offers entry and crossing profiles and is precision engineered for crossing and treating extremely tight and complex lesions.

“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 at Piedmont Heart Institute in Atlanta, Ga., 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.”

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).
 
Scott Ward, CSI’s Chairman, president and CEO, said, “Offering the Sapphire II PRO 1 mm 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 mm balloon complements our orbital atherectomy system as we continue providing advanced solutions for treating the complex and high-risk indicated patient.”
 
At launch, CSI will offer both the 1-4 mm Sapphire II PRO and the 2-4 mm Sapphire NC Plus non-compliant coronary balloons on a limited basis. The company expects that OrbusNeich’s full balloon product portfolio will become available in the United States throughout 2018 and 2019.

OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products include the world’s first dual therapy stents, the COMBO Plus and COMBO Dual Therapy Stents, together with stents and balloons marketed under the names of Azule, Scoreflex, Sapphire II, Sapphire II PRO and Sapphire II NC, as well as products to treat peripheral artery disease: the Jade and Scoreflex PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.,; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries.
 
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The FDA granted the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, over 356,000 of CSI’s devices have been sold to leading institutions across the United States.
 
The Sapphire II PRO Coronary Dilatation Catheter (1-1.25 mm configurations) is indicated for balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70 percent stenosis) for the purposes of improving myocardial perfusion. The Sapphire II PRO Coronary Dilatation Catheter (1.5-4 mm configurations) is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion, and balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.