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The Diamondback 360 Coronary Orbital Atherectomy System Receives CE Mark

Diamondback 360 Coronary Orbital atherectomy system is the market-leading coronary atherectomy device in the United States. Diamondback combines differential sanding and pulsatile forces to treat all calcium modalities, including nodular, eccentric (irregular) and concentric (ring-shaped).

Diamondback 360 Coronary Orbital Atherectomy System Large Study Demonstrates Exceptional Safety and High Procedural Success: Reported at TCT Connect 2020

Diamondback 360 Coronary Orbital Atherectomy System Large Study shows exceptional safety and high procedural success in 519 patients with severely calcified cardiac disease who were treated with orbital atherectomy prior to stent deployment.

Cardiovascular Systems Announces Presentation of Data From Large Coronary Orbital Atherectomy Study at the TCT Connect 2020 Conference

This is a large retrospective observational study from a high volume, tertiary center treating complex severely calcified de novo coronary lesions that underwent lesion preparation with OAS before stent deployment.

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.