Cardiology News Alerts

• 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
• Alert EU Officials Recall Some Valsartan Medicines Due to Impurity The European Medicines Agency is reviewing the medicines after an impurity, thought to be a probable human carcinogen, was detected in the active ingredient supplied by a Chinese company.
  News Alerts, July 2018
• Alert The Best Children's Hospitals, According to US News For the fifth consecutive year, Boston Children's Hospital is ranked number 1 by US News & World Report.
  Medscape Medical News, June 2018
• Alert FDA Issues Leak Safety Alert for Endologix AAA Repair Grafts Regulators say the company's AFX endovascular graft system with Strata material -- used for abdominal aortic aneurysm repair -- is at greater risk for type III endoleaks compared with other devices for the same indication.
  News Alerts, June 2018
• Alert FDA Issues Recall of Maquet Datascope CARDIOSAVE Hybrid IABPs Fluids spilled on the consoles might seep inside and corrode circuit boards or otherwise cause the intra-aortic balloon pump systems to malfunction, regulators say.
  News Alerts, June 2018
• Alert FDA Class I Recall for Medtronic HeartWare VAD The recall, affecting more than 200,000 devices, is due to the possibility of interruption in the electrical connection between the system's power source and the HVAD controller.
  News Alerts, June 2018
• Alert FDA OKs Consensi for Osteoarthritis Pain and Hypertension The FDA has approved a combination of amlodipine besylate and celecoxib (Consensi, Kitov Pharma) for individuals with osteoarthritis pain and hypertension.
  FDA Approvals, June 2018
• Alert FDA OKs Abbott's Next-Gen Drug-Eluting Stent Xience Sierra The Xience Sierra is specifically designed to treat complex blockages, which now account for up to 70% of cases, the company said.
  FDA Approvals, May 2018
• Alert FDA Class I Recall for HeartMate 3 Left Ventricular Assist System The FDA issued a Class I recall for the left ventricular assist system because of a potential malfunction that may lead to graft occlusion.
  Medscape Medical News, May 2018
• Alert FDA Clears Next-Gen Stroke Stent Retriever EmboTrap II The EmboTrap II retriever showed favorable rates of reperfusion, high rates of successful removal of the clot on the first attempt, and good clinical outcomes in the ARISE II study.
  FDA Approvals, May 2018
• Alert FDA Approves Lokelma for Hyperkalemia The FDA has approved sodium zirconium cyclosilicate -- a medication that rapidly restores normal potassium levels -- for adults with hyperkalemia.
  FDA Approvals, May 2018
• Alert FDA Approves First Factor Xa Inhibitor Antidote, Andexxa Access to a rapid reversal agent represents a major advance for patients treated with a factor Xa inhibitor, who now rank in the millions, but the agent does come with a boxed warning.
  FDA Approvals, May 2018
• Alert FDA Expands Indication for IN.PACT Admiral Balloon in PAD The IN.PACT Admiral DCB is now indicated to treat long superficial femoral artery lesions up to 360 mm in patients with peripheral artery disease.
  FDA Approvals, April 2018
• Alert Dabigatran Antidote Praxbind Picks Up Full FDA Approval Granted accelerated approval in 2015, the company now has received full FDA approval for idarucizumab to reverse the effects of dabigatran.
  FDA Approvals, April 2018
• Alert FDA OKs Firmware Update for ICD, CRT-D Battery, Security Glitches The FDA-approved update for the defibrillator implants from Abbott, formerly St Jude Medical, separately addresses previously identified cybersecurity and battery-depletion issues.
  News Alerts, April 2018
• Alert FDA OKs ASD Device for PFO Closure to Prevent Recurrent Stroke
  FDA Approvals, April 2018
• Alert FDA Clears World's Smallest Mechanical Heart Valve Expanded approval for Abbott’s Masters Series 15-mm heart valve fills an unmet need in newborns and infants with heart defects, who may be too small for currently available valves, the FDA says.
  FDA Approvals, March 2018
• Alert FDA: Class I Recall of 48 Medtronic ICDs, CRT-Ds Clinicians received serial numbers in January and were asked to consider replacement of the affected devices, said to have a manufacturing defect that might prevent shock or pacing therapy.
  News Alerts, February 2018
• Alert FDA Approves First 2.0-mm Drug-Eluting Stent in US The approval taps into a patient population with an unmet clinical need and expands Medtronic's device platform from sizes 2.0 mm to 5.0 mm.
  FDA Approvals, February 2018