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Cardiovascular Systems, Inc. (CSII) announced FDA PMA approval for OrbusNeich’s Scoreflex NC Scoring PTCA Catheter, designed for treating coronary artery disease. This innovative device facilitates controlled plaque modification in coronary arteries. The pivotal clinical study involving 200 patients showed strong safety and success metrics for the device. Company officials expressed optimism about its potential to improve patient outcomes and expand treatment options. This development may enhance CSII’s product portfolio and market position in interventional cardiology.
Cardiovascular Systems, Inc. (CSII) has made strides in commercializing intravascular lithotripsy (IVL) systems for treating calcific artery disease. With feasibility testing of its proprietary console and IVL balloon catheters completed, the new systems aim to enhance treatment options for challenging atherosclerotic lesions. This addition is poised to triple CSII's addressable market in the U.S. to
Cardiovascular Systems, Inc. (NASDAQ: CSII) will host a live webcast on
Cardiovascular Systems, Inc. (CSII) has issued a voluntary recall of the WIRION Embolic Protection Systems due to complaints of filter breakage during retrieval. The company has received nine complaints concerning this issue, which could lead to device embolism and additional interventions. A total of 697 devices distributed in the U.S. between March 22, 2021, and November 15, 2021, are being recalled. Healthcare facilities are advised to discontinue use and return the products while the FDA has been notified.
Cardiovascular Systems, Inc. (CSII) reported fiscal Q1 2022 revenues of $58.4 million, down 3.6% year-over-year, largely due to COVID-19 Delta variant impacts on procedure volumes. U.S. peripheral revenues fell 9.4%, while coronary revenue rose 1.7%. The company updated its fiscal year 2022 revenue guidance to between $265 million and $285 million, suggesting 2% to 10% growth. Despite a net loss of $8.6 million and rising expenses, CSI remains optimistic about recovery in procedure volumes and ongoing international market growth.
Cardiovascular Systems, Inc. (CSII) has initiated enrollment in a first-in-human trial for its coronary everolimus drug-coated balloon (DCB) developed by Chansu Vascular Technologies (CVT). The first patient was treated successfully by Dr. Irakli Gogorishvili in Tbilisi, Georgia, targeting in-stent restenosis. The trial aims to enroll 50 patients across 15 sites in France, Georgia, Lithuania, and Spain to support FDA submissions. CSI is providing milestone-based financing to CVT and holds an option for acquisition upon achievement of specific milestones.
Cardiovascular Systems, Inc. (CSII), a St. Paul-based medical device company, announced plans to participate in the Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16, 2021, at 10:00 a.m. ET. During this event, management will present and hold investor meetings, focusing on their innovative interventional treatment systems for patients with peripheral and coronary artery disease. CSII's orbital atherectomy system addresses significant challenges associated with existing treatment options for vascular and coronary diseases.
Cardiovascular Systems, Inc. (NASDAQ: CSII) will hold a live webcast of its fiscal 2022 Q1 conference call on November 9, 2021, at 8:00 a.m. CT. The call will discuss the financial results for the quarter ending September 30, 2021, along with the company's outlook. An earnings release will precede the call. The company specializes in innovative medical devices for treating vascular disease, particularly through its orbital atherectomy system.
Cardiovascular Systems, Inc. (CSII) announced the successful treatment of the first patient using its ViperCross peripheral support catheter. The procedure, performed by Dr. Billy J. Kim in Nashville, Tennessee, highlights ViperCross's ability to navigate complex vascular anatomy with enhanced guidewire support. This launch expands CSI's portfolio addressing peripheral artery disease (PAD), which affects around 18 million Americans, predominantly over age 65. CEO Scott R. Ward emphasized that ViperCross enhances treatment capabilities for physicians managing complex interventions.
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