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    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. Acquires Gardia Medical Ltd.’s WIRION™ Embolic Protection System

    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.”

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

    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.

    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.

    First Patients Treated from Radial Access Using Diamondback 360® Extended Length Peripheral Orbital Atherectomy Device

    Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for peripheral and coronary artery disease, announced today that the first patients were treated using its FDA-cleared extended length Diamondback 360® Peripheral Orbital Atherectomy Device to treat peripheral artery disease

    FDA Approves Cardiovascular Systems’ Replacement Saline Infusion Pump

    Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement...

    Cardiovascular Systems to Webcast Fiscal 2017 Third-Quarter Earnings Conference Call Wednesday, May 3

      Conference Call Wednesday, May 3 Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII) will host a live webcast of its fiscal 2017 third-quarter conference call on Wednesday,...

    Cardiovascular Systems Enrolls First Subject in ECLIPSE Coronary Clinical Trial

    ECLIPSE Trial Compares Treatment Strategies for Patients with Severely Calcified Coronary Arteries Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), in partnership with Cardiovascular Research Foundation (CRF),...

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