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Cardiovascular Systems Presents REACH PVI Study at the New Cardiovascular Horizons Conference

REACH PVI study prospectively evaluated acute clinical outcomes of orbital atherectomy via transradial access for the treatment of peripheral artery disease (PAD) in lower extremity lesions.

Peripheral Orbital Atherectomy System With GlideAssist® Introduced in Europe

The 1.25 Micro Crown is designed with flexibility for tortuous vessels and tight bends below the knee.

Coronary ViperWire Advance® With Flex Tip Receives FDA Approval

ViperWire Advance with Flex Tip is the latest advancement to CSI’s coronary Diamondback 360® orbital atherectomy system. Diamondback is the only atherectomy device to treat calcific coronary artery disease by both safely reducing superficial lesions and creating fractures of deep calcium, facilitating stent delivery, expansion and wall apposition for low restenosis rates.

Cardiovascular Systems, Inc. Receives Approval for the Diamondback 360® Coronary Orbital Atherectomy System with Classic Crown and New ViperWire Advance® FlexTip Guidewire in Japan

CSI received MHLW approval for the Diamondback 360® Coronary OAS Micro Crown in March 2017 and reimbursement approval in February 2018. In November 2016, CSI announced that Medikit, Co., Ltd. signed an exclusive distribution agreement to sell its coronary and peripheral OAS in Japan.

First Patients Are Treated in the United States with OrbusNeich Teleport® Microcatheter

12/27/18: The OrbusNeich® Teleport Microcatheter (Teleport), recently received U.S. Food and Drug Administration 510(k) clearance.

First Commercial Launch of Peripheral Orbital Atherectomy System Outside the United States Reports Cardiovascular Systems

9/19/18: Dr. Bryan Yan, Associate Professor, Chinese University of Hong Kong, who treated the first patient in Hong Kong, said, “Patients with severely calcified peripheral arteries can be difficult to treat due to the limitations of traditional angioplasty or stenting. This can also place patients at risk for subsequent complications including repeat interventions and amputation. The commercialization of the Stealth 360® OAS in Hong Kong provides physicians with a minimally invasive treatment option for this complex patient population. I am very satisfied with the procedural outcome for my patient because I was able to avoid implanting a stent in the distal superficial femoral artery and I look forward to continuing treatment of similar patients with this technology.”

Cardiovascular Systems Presents LIBERTY 360° 18-Month Outcomes at CRT18 Interventional Cardiology Conference

3/6/18: Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, presented 18-month outcomes from its LIBERTY 360° study at the Cardiovascular Research Technologies (CRT) 2018 interventional cardiology conference in Washington, D.C. The study evaluates the acute and long-term clinical and economic outcomes of endovascular device interventions, including CSI’s orbital atherectomy system, in treating peripheral artery disease (PAD).

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.

3/1/18: Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.