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Shockwave Set to Launch C²⁺ Coronary IVL Catheter in the US

October 20, 2023—Shockwave Medical announced the planned introduction of its Shockwave C2+ coronary intravascular lithotripsy (IVL) catheter in the United States, with a debut set for the Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium in San Francisco, October 23-26.

CSI's Coronary ViperWire Advance With Flex Tip Gains FDA Approval

September 24, 2019—Cardiovascular Systems, Inc. (CSI) announced FDA premarket approval of the company's ViperWire Advance coronary guide wire with Flex Tip, which is the latest advancement in CSI’s coronary Diamondback 360 orbital atherectomy system (OAS).

CSI Launches Diamondback 360 Coronary Orbital Atherectomy Systems

December 3, 2013—Cardiovascular Systems, Inc. (CSI, St.

Magenta Medical’s Elevate pLVAD Evaluated in Early Feasibility Study

June 7, 2023—Magenta Medical, an Israel-based medical device company, announced the initiation of its FDA-approved early feasibility study (EFS) with the Elevate percutaneous left ventricular assist device (pLVAD) for an indication of high-risk percutaneous coronary intervention (HR-PCI).

ECLIPSE Trial of CSI's Orbital Atherectomy System Begins Enrollment

March 28, 2017—Cardiovascular Systems, Inc. (CSI), in partnership with the Cardiovascular Research Foundation, announced the commencement of enrollment in the ECLIPSE clinical trial that will evaluate CSI's Diamondback 360 coronary orbital atherectomy system (OAS).

Shockwave Begins DISRUPT CAD III Pivotal Trial of Coronary Intravascular Lithotripsy

January 14, 2019—Shockwave Medical, Inc. announced that it has initiated the pivotal DISRUPT CAD III clinical trial, its FDA investigational device exemption (IDE) study evaluating the use of intravascular lithotripsy (IVL) in heavily calcified coronary arteries.

SpectraWave HyperVue Imaging System Enhancements Cleared by FDA

September 19, 2023—SpectraWave, Inc. announced FDA 510(k) clearance for product enhancements to the HyperVue imaging system.

Thirty-Day Results Presented From CSI's COAST IDE Study

February 22, 2016—Cardiovascular Systems, Inc. (CSI) announced the presentation of 30-day results from the COAST study of its coronary orbital atherectomy system (OAS) in a late-breaking presentation at the 2016 Cardiovascular Research Technologies (CRT) conference in Washington, DC.

Shockwave Launches C²⁺ IVL Catheter Internationally, Commences All-Female EMPOWER CAD Study

May 15, 2023—Shockwave Medical, Inc. announced the full commercial availability in select international markets of the Shockwave C2+ coronary intravascular lithotripsy (IVL) catheter.