Cardiovascular Systems (NSDQ:CSII) said today that it won pre-market approval from the FDA for a new ViperWire Advance coronary guidewire for orbital atherectomies using its Diamondback 360 device. The new guidewire features a floppy, shapeable tip designed to navigate complex anatomies and reduce wire bias, the St. Paul, Minn.-based company said. “We remain committed to expanding […]
Study shows few amputations following treatment with Cardiovascular Systems’ PAD system
A study of peripheral vascular interventions in patients with peripheral artery disease (PAD) has demonstrated “high freedom” from major amputation at three years, according to study sponsor Cardiovascular Systems. The Liberty 360° study enrolled more than 1,200 patients at 51 sites across the U.S. It followed patients across the spectrum of symptomatic PAD, and included […]
Cardiovascular Systems acquires Gardia Medical’s embolic protection system
Cardiovascular Systems (NSDQ:CSII) yesterday announced that it acquired the Wirion Embolic Protection System and its related assets from Gardia Medical for $5.6 million. Cardiovascular Systems paid $5.6 million for the system and $1.5 million will be held in escrow until the 12 months following a successful manufacturing transfer. The company also issued Gardia 31,493 shares of […]
Ex-Medtronic CFO Ellis joins Inspire Medical board | Personnel Moves, August 2, 2019
Inspire Medical Systems last week named Gary Ellis, the former CFO at Medtronic (NYSE:MDT), to its board of directors effective immediately. Minneapolis-based Inspire Medical also said that Amzak Health managing partner Joyce Erony left the board effective yesterday. Ellis spent 27 years at Medtronic before retiring in 2016. “On behalf of the entire Inspire board […]
Cardiovascular Systems beats Wall Street in Q3 reports
Cardiovascular Systems (NSDQ:CSII) posted third-quarter fiscal year 2019 results today that topped the consensus forecast on Wall Street, posting earnings per share of 2¢. The St. Paul, Minn.-based company reported profits of $672,000, or 2¢ per share, on sales of $63.3 million for the three months ending March 31, for a bottom-line gain of 84.1% on […]
Cardiovascular Systems posts Street-beating FY2019 Q2 earnings
Cardiovascular Systems (NSDQ:CSII) today posted fiscal year 2019 second quarter earnings that beat expectations on Wall Street. The St. Paul, Minn.-based company posted profits of $492,000, or 1¢ per share, on sales of approximately $60.2 million for the three months ended December 31, seeing a swing from the red on the bottom line while sales grew […]
JenaValve names Kilcoyne as CEO | Personnel Moves – January 15, 2019
JenaValve Technology said today that it named former ReVision Optics prez & CEO John Kilcoyne as its new chief executive officer, effective immediately, replacing Dr. Victoria Carr-Brendell, who has taken up an executive leadership position with Sonova Holding AG (SIX:SOON). Prior to his time at ReVision Optics, Kilcoyne served as prez & CEO at Micrus Endovascular where he […]
Abiomed jumps on fiscal Q3 prelims, raised outlook | Wall Street Beat
Abiomed (NSDQ:ABMD) shares got a jump today from its preliminary fiscal third-quarter numbers and an improved outlook for the rest of its fiscal year. The Danvers, Mass.-based heart pump maker said it expects to post fiscal Q3 sales of roughly $200.6 million, representing a 30.3% increase over its fiscal Q3 top line. Abiomed also raised […]
Cardiovascular Systems wins Japanese nod for next-gen Diamondback 360 atherectomy device
Cardiovascular Systems (NSDQ:CSII) said today it won approval from Japan’s Ministry of Health, Labor and Welfare for its Diamondback 360 coronary orbital atherectomy system and its Classic Crown and ViperWire Advance coronary guidewire FlexTip. The Classic Crown includes a a 1.25mm diamond-coated crown and uses centrifugal force and differential sanding to safely modify arterial calcium, the […]
Cardiovascular Systems touts first patients treated with Teleport microcatheter
Cardiovascular Systems (NSDQ:CSII) touted today that the first patients in the U.S. were treated with the OrbusNeich Teleport microcatheter. The device, which recently won 510(k) clearance with the FDA, enables safe guidewire exchange during cardiovascular procedures. The Teleport product features a robust tip to provide access to challenging lesions, according to Cardiovascular Systems. Dr. Annapoorna Kini, […]
Cardiovascular Systems enters Chinese market through OrbusNeich deal
Cardiovascular Systems (NSDQ:CSII) said today that it successfully launched its Diamondback 360 coronary orbital atherectomy system in China as part of a distribution agreement with OrbusNeich. St. Paul, Minn.-based Cardiovascular Systems said that the first patient has already been treated with the device in Hong Kong. “Orbital Atherectomy is simple to use. It is a very controllable […]
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