Recent developments of interest in cardiovascular medicine
And the U.K. approved early access to LCZ-696 (Entresto) while awaiting the European Commission approval for heart failure, despite the $12.50 per pill ($25 per day) price-tag.
The FDA approved a new 60-mg dose of ticagrelor (Brilinta) for use with aspirin in an expanded indication for long-term use in acute coronary syndrome patients, and patients who have previously had a myocardial infarction (MI). Additional data released from the PEGASUS trial, upon which the indication was based, showed that stopping ticagrelor too soon can increase the risk of stroke or cardiovascular death.
An NBC News investigation suggests Bard downplayed the 300 non-fatal problems and 27 deaths related to its Recovery inferior vena cava filter, hiring a public relations firm instead of recalling the device. A regulatory specialist who refused to sign the FDA application over safety concerns indicated her signature might have been forged.
In other industry news, Abbott finished acquiring the mitral valve replacement company Tendyne and Medtronic bought Medina Medical, which makes a transcatheter embolization device for cerebral aneurysms.
The FDA extended the PDUFA response date for sebelipase alfa (Kanuma), an investigational enzyme replacement therapy for lysosomal acid lipase deficiency. The agency gave itself until Dec. 8 to review Alexion's response to its question on manufacturing. Meanwhile, the drug was approved by the European Commission to treat the "ultra-rare" metabolic disease.
Mitralign got clearance from the FDA to start phase I feasibility studies with its percutaneous tricuspid valve.
The factor VIIIa-mimetic bispecific antibody ACE-910 got breakthrough therapy status from the FDA for prophylactic treatment of hemophilia A.
Injections of abobotulinumtoxinA eased upper limb spasticity in stroke patients and those with traumatic brain injury in a pivotal phase III trial, with effects lasting up to 20 weeks.
Total knee replacement was associated with elevated 30-day risk of MI and risk of venous thromboembolism that persisted for years after the procedure, a large study showed.
Most cardiac resynchronization therapy (CRT) pacemaker patients don't need a defibrillator, the CeRtiTuDe cohort study showed.
European cardiomyopathy patients are getting more defibrillators than expected, and more genetic testing too, a registry found.
Heart age, reflecting cardiovascular risk profile, averages 7.8 and 5.4 years older than chronological age for men and women, respectively, the CDC reported from national data.
The FDA cleared a wireless digital stethoscope, Eko Core, for use as a Class II device, although cardiologists' auscultation skills with even a traditional stethoscope got a failing grade overall.
The agency warned Cardiac Designs that the plant making its ECG Check Wireless Lead Cardiac Monitor doesn't meet good manufacturing practice requirements, particularly in design validation and in handling complaints about the device.
The BioMonitor 2 device for remote monitoring of heart rhythms got clearance from European regulators. Device maker Biotronik released results of a pilot study showing 90% success in sending transmissions from the device.
CardioBreak is a guide to what's new and interesting on the Web for cardiologists and other healthcare professionals with an interest in cardiovascular disease, powered by the MedPage Today community. Got a tip? Send it to us: c.phend@medpagetoday.com.
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