Cardiology News Alerts

• Alert FDA Flags Design Correction for Stöckert 3T Heater-Cooler System The FDA is alerting physicians to labeling changes and a design correction for the Stöckert 3T Heater-Cooler System to reduce infections after cardiac and other surgeries.
  News Alerts, October 2018
• Alert Endologix Broadens Recall to All AFX Endovascular AAA Systems The company is recalling all AFX endovascular aortic aneurysm systems after continued problems with type III endoleaks. The FDA has now classified the recall as class I, the most serious designation.
  News Alerts, October 2018
• Alert EMA Takes Further Action in Ongoing Review of Tainted 'Sartans' The European Medicines Agency (EMA) has placed Zheijiang Huahai Pharmaceuticals under increased supervision and stopped Aurobindo Pharma from supplying irbesartan to the European Union.
  News Alerts, October 2018
• Alert FDA Okays Rivaroxaban Plus Aspirin for Chronic CAD, PAD The rivaroxaban/aspirin combination is for the prevention of thrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events.
  FDA Approvals, October 2018
• Alert FDA Warns of Cyber Concerns With Implantable Pacemakers Hacking concerns prompted the FDA to issue a safety alert and Medtronic to disable online updates for its CareLink 2090 and CareLink Encore 29901 programmers.
  News Alerts, October 2018
• Alert FDA OKs Inotersen for Hereditary ATTR With Polyneuropathy Inotersen treatment led to improvements in neurologic and quality-of-life endpoints in patients with hereditary transthyretin amyloidosis with polyneuropathy in a pivotal phase 3 trial.
  FDA Approvals, October 2018
• Alert FDA Clears First Autoinjectable Testosterone, Xyosted Xyosted is the first self-injection testosterone replacement product for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone.
  FDA Approvals, October 2018
• Alert FDA Freezes Imports From Chinese Maker of Tainted Valsartan The FDA's import alert bans all ingredients and finished drug products made by Zhejiang Huahai Pharmaceuticals from legally entering the United States.
  News Alerts, September 2018
• Alert FDA Approves Eluvia Paclitaxel-Polymer Stent for PAD Approval of the Boston Scientific stent for peripheral arterial disease, which is designed to delivery paclitaxel gradually over the course of a year, was based on the IMPERIAL trial.
  FDA Approvals, September 2018
• Alert FDA OKs Augmented Reality GLOW800 Vascular Fluorescence Newly approved GLOW800 provides surgeons with a 'complete view of anatomy and physiology during vascular neurosurgery, the company says.
  FDA Approvals, September 2018
• Alert FDA OKs PK Papyrus Stent for Acute Coronary Artery Perforations The approval marks the first time in nearly two decades that the agency has approved a coronary stent for this indication.
  FDA Approvals, September 2018
• Alert FDA Rejects Volanesorsen (Waylivra) for Rare Triglyceride Disorder Volanesorsen, intended to treat the ultrarare lipid disorder familial chylomicronemia syndrome, was given a thumbs up by an FDA advisory committee in May.
  Medscape Medical News, September 2018
• Alert Recall of Hypertension Meds Containing Wrong Drug Accord Healthcare has issued a recall for a blood pressure medication because the bottles that were shipped actually contain a heart failure drug.
  WebMD Health News, August 2018
• Alert EC Approves Rivaroxaban Plus Aspirin Regimen for CAD, PAD The rivaroxaban/aspirin combination is for the prevention of thrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events.
  International Approvals, August 2018
• Alert FDA Flags Temporary Artificial Heart for Mortality, Stroke Risk The letter to healthcare providers was issued after the agency reviewed final results of a postmarket study conducted by the device maker, SynCardia Systems.
  News Alerts, August 2018
• Alert Triggers of Takotsubo Syndrome Point to Differing Prognoses A new study finds unique differences in survival but also raises questions about how best to classify these patients and why so many have no identifiable triggering event.
  Medscape Medical News, August 2018
• Alert FDA Approves First Oral Drug for Fabry Disease Migalastat (Galafold) is for adults with Fabry disease who have a genetic mutation amenable to treatment based on laboratory data.
  FDA Approvals, August 2018
• Alert Tainted Valsartan Recall Expands as More Drug Makers Implicated Health officials in the US and Europe have expanded their recalls of valsartan medications because some of the medicines contain a potentially cancer-causing substance.
  News Alerts, August 2018
• Alert FDA Gives Nod to Next-Generation MitraClip System The third-generation system includes two devices, both designed to improve deliverability and precision.
  FDA Approvals, July 2018
• Alert FDA Approves HeartWare LVAD for Implant via Thoracotomy Implanting Medtronic's HeartWare ventricular assist device via the less invasive approach was shown to be safe and effective in the LATERAL clinical trial.
  FDA Approvals, July 2018