Cardiovascular Systems

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

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.

Scott Ward, CSI Chairman, President and Chief Executive Officer, said, “The acquisition of the WIRION System further supports our commitment and mission of building a comprehensive portfolio of differentiated products aimed at saving limbs and improving outcomes for patients undergoing complex peripheral interventions.”

1/2/19: 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.

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

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.”

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).

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.