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10 important FDA announcements in 2018
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Less than 3 months into 2018, the field of cardiology has already seen its fair share of FDA news.
Cardiology Today and Cardiology Today’s Intervention have compiled a list of important product approvals, clearances and recalls since the start of the year.
Smallest available heart valve receives FDA approval
The FDA announced the approval of a heart valve designed for pediatric patients has been expanded to include a size small enough to be used in newborn patients.
The approval of the valve (Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff, Abbott) now includes a 15-mm size, and that size of the device is now the smallest mechanical heart valve approved in the world, according to a press release from the agency.
FDA categorizes recall of ICDs, CRT-Ds as class I
The FDA announced it has identified a recall of certain implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators made by Medtronic as class I, the most serious kind.
According to an alert by the agency, Medtronic began the recall in January due to a defect in the devices’ manufacturing process which could lead to an error preventing electrical shock delivery.
FDA warns clarithromycin may be risky for patients with heart disease
The FDA announced that health care providers should be cautious before prescribing the antibiotic clarithromycin to patients with heart disease due to the potential risk for additional heart problems and death years later.
Clarithromycin (Biaxin, Abbvie) is typically used to treat patients with infections that affect areas such as sinuses, skin, ears and lungs, according to an FDA MedWatch drug safety communication.
FDA approves ready-to-use version of bivalirudin for PCI
Baxter International Inc. announced the FDA approved its ready-to-use version of bivalirudin as an anticoagulant in patients undergoing PCI.
According to a press release from the company, its version of the direct thrombin inhibitor bivalirudin (Bivalirudin in 0.9 percent Sodium Chloride Injection) will use a non-PVC and non-DEHP system (Galaxy container technology) designed to create a ready-to-use format for unstable molecules.
CRT defibrillator, ICD receive labeling approval from FDA
Abbott announced that a cardiac resynchronization therapy defibrillator and an implantable cardioverter defibrillator to treat patients with potentially life-threatening heart rhythms and congestive HF have received magnetic resonance-conditional labeling from the FDA.
The CRT defibrillator (Quadra Assura MP, Abbott) allows the lower chamber of the heart to beat in rhythm while improving blood flow, whereas the ICD (Fortify Assura, Abbott) restores normal heart rhythms, according to a press release from the company.
FDA alerts health care providers of treatment delivery failure in wearable defibrillators
The FDA announced that health care providers should be aware of potential treatment delivery failure in a wearable defibrillator, which may lead to harm or death in adults with arrhythmias and children at risk for sudden cardiac arrest.
The device (LifeVest 4000, Zoll) may fail if it is not replaced after a message is displayed: “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.” Failure to replace the device may result in the patient not receiving the appropriate therapy, but the message code “does not explicitly indicate that the device cannot be used and that the patient should call Zoll immediately,” according to an FDA MedWatch safety communication.
Steerable introducer sheath undergoes Class I recall
The FDA has designated a recall for a steerable introducer sheath as a Class I recall, the most serious kind.
According to a safety alert from the FDA, the reprocessed Agilist Steerable Introducer Sheath (Sterilmed), designed to prevent blood flow from moving back through a hemostatic valve, may fail due to improper seals, which can allow blood to leak through the hub, causing the cap to fall off during the procedure or creating a difference in pressure, causing an air embolism.
Aspiration system for stroke treatment receives FDA clearance
Medtronic announced the FDA clearance of an aspiration system for use in the treatment of acute ischemic stroke.
According to a press release from the company, the aspiration system (Riptide) is designed to retrieve thrombus and restore blood flow in patients experiencing ischemic stroke as a secondary treatment to intracranial large vessel occlusive disease within 8 hours of symptom onset.
Heart pumps receive expanded FDA indication for high-risk PCI
Abiomed announced that the FDA has approved an expanded indication for two of its heart pumps.
Under the new indication, the pumps (Impella 2.5 and Impella CP, Abiomed) can now be used in patients with severe CAD, extensive comorbidities and complex anatomy with or without depressed ejection fraction who are undergoing high-risk PCI procedures, according to a press release issued by the company.
FDA categorizes past recall of TAVR delivery system as Class I
The FDA announced it has classified Edwards Lifesciences’ past voluntary recall of a transcatheter heart valve delivery system as a Class I recall, the most serious kind.
In an email to Cardiology Today’s Intervention, the company said the move concerned “an old recall that was resolved” without any harm to patients.