The FDA has classified Cordis‘ recall of its Precise Pro Rx carotid system as Class I, the most serious kind of recall. Cordis in February recalled certain lots of its Precise Pro RX carotid stent systems because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients. The […]
Cordis Corp.
Silk Road Medical issues voluntary recall of Enroute transcarotid stent system
Silk Road Medical (NSDQ:SILK) announced today that it is voluntarily recalling additional lots of its Enroute transcarotid stent system. Enroute, which is manufactured by Cardinal Health (NYSE:CAH) subsidiary Cordis, has received a total of six product complaints between September 2020 and January 2021 involving an issue in which a tip detaches from the stent delivery system. Additionally, test […]
Cardinal Health’s Cordis expands recall of some Powerflex Pro catheters
Cardinal Health (NYSE:CAH) subsidiary Cordis this week expanded the recall of some of its Powerflex Pro catheters for treating peripheral artery disease, adding three lots to the list. Santa Clara, Calif.-based Cordis first recalled five lots of the Powerflex Pro device in Sept. 6, 2018, after a supplier said they didn’t meet an internal specification for […]
Cardinal Health beats The Street on Q2 & FY 2019 earnings, expects $145 million restructuring charge
Cardinal Health (NYSE:CAH) beat Wall Street’s earnings consensus by 10% for the fourth quarter of 2019, despite a disappointing performance by its medical sector. The Dublin, Ohio-based company posted profits of $194 million or $0.65 per share on sales of $37.4 billion for the three months ended June 30, 2019, for a bottom-line gain of […]
Cardinal Health’s Cordis launches Mynx Control vascular closure system
Cardinal Health (NYSE:CAH) subsidiary Cordis said last Friday that it launched the Mynx Control vascular closure device intended for sealing 5-7 French femoral arterial access sites. The newly launched system is intended to reduce time to hemostasis and ambulation after diagnostic or interventional procedures, the Dublin, Ohio-based company said. The system also includes a next-generation deployment system designed to […]
Aegea Medical picks up former Cardiokinetix, Concentric Medical CEO Sainz | Personnel Moves – May 14, 2018
Aegea Medical said last week it tapped former Cardiokinetix prez & CEO Maria Sainz as its new president and chief executive officer, effective immediately. Sainz will replace former CEO Don Gurskis, who has held the corner office since 2013. Gurskis will remain on as member of the Redwood City, Calif.-based company’s executive management team. “Maria is […]
Cardinal Health’s Cordis wins date with FDA panel for Incraft AAA stent graft
Cardinal Health (NYSE:CAH) subsidiary Cordis this week won a June date with an FDA panel looking to discuss the premarket approval application for its InCraft AAA stent graft system designed for treating infrarenal abdominal aortic aneurysms. On June 12, the FDA’s Medical Device Advisory Committee’s Circulatory Systems Devices Panel will meet to discuss possible marketing applications for […]
US Court of Appeals revives Medinol stent suit against Cordis
The US Court of Appeals for the Federal Circuit this week revived a stent patent infringement suit brought by Medinol against Cordis and its former parent company Johnson & Johnson (NYSE:JNJ). The suit, originally filed in 2013, claimed that Cordis infringed on Medinol stent patents filed between 1999 and 2005. The case was vacated in 2014 […]
Cordis, Medinol tout first commercial implants of Elunir drug-eluting stent in U.S.
Cordis and Medinol announced today that the first commercial uses of the Elunir drug-eluting stent in the U.S. were performed at New York-Presbyterian Hospital/Columbia University Medical Center and the Piedmont Heart Institute in Atlanta. The Elunir stent, developed by Medinol and distributed by Cordis, features a metallic spring tip and the narrowest strut width of any stent on […]
Cordis, Medinol win FDA nod for Elunir drug-eluting stent
Cordis and Medinol announced today that the FDA approved its Elunir drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries. The stent, designed by Medinol and distributed exclusively by Cordis in the U.S., features a novel metallic spring tip and the narrowest strut width of any stent on the market in the U.S., according […]
Cordis inks exclusive distribution deal for Medinol’s coronary stent portfolio in US
Cordis has inked an exclusive distribution deal to sell Medinol‘s coronary stents in the U.S., the company reported, adding a cobalt-chromium bare-metal stent and a drug-eluting stent to its portfolio. According to the deal, Cordis plans to start selling Medinol’s NIRxcell BMS immediately and will exclusively distribute the company’s EluNir drug-eluting stent if it wins FDA approval. […]
