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11 important cardiology FDA approvals in 2017
In addition to numerous medical devices, the FDA approved a total of 46 drugs in 2017, tying a record previously set in 2015.
Cardiology Today and Cardiology Today’s Intervention has compiled a list of important product approvals and clearances in the last year.
Smartphone-compatible implantable cardiac monitor receives FDA clearance
Abbott announced that its smartphone-compatible implantable cardiac monitor designed to remotely identify cardiac arrhythmias has received FDA clearance.
According to a press release issued by the company, the implantable cardiac monitor (Confirm Rx) can provide U.S. patients with new methods of monitoring arrhythmias while remotely connecting with their physician.
Next-generation troponin T test receives FDA clearance
Roche Diagnostics Corp. announced that the FDA has cleared its next-generation troponin T assay for use in patients presenting with suspected MI.
The blood test (Elecsys Troponin T Gen 5 STAT) can accurately detect lower levels of troponin and more rapidly aid in the diagnosis of patients with acute MI, the company stated in a press release.
First dedicated coronary bifurcation stent receives FDA approval
Tryton Medical Inc. announced the FDA premarket approval of a stent designed for the treatment of coronary bifurcation lesions involving large side branches.
The stent (Tryton Side Branch Stent) is the first specifically designed for treatment of coronary bifurcation lesions to receive FDA approval, according to a press release issued by the company.
Newest-generation self-expanding TAVR device receives FDA approval
Medtronic announced the FDA approved a new version of its self-expanding transcatheter aortic valve replacement system designed to improve valve sealing performance.
The valve (CoreValve Evolut PRO) is indicated for treating severe aortic stenosis in patients at high or extreme risk for open-heart surgery, according to a press release issued by the company.
ICD, CRT-D systems receive FDA approval for MRI
Boston Scientific announced that the FDA has approved an MRI labelling for its line of implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems for the management of HF.
The family of systems (Resonate) includes an HF diagnostic tool (HeartLogic) that notifies clinicians of a patient’s worsening HF through the evaluation of thoracic impedance, respiration volume and rate, heart sounds, and heart rate and activity, according to a press release from the company. The device can alert clinicians of an impending HF event in a median of 34 days.
Nanocoated coronary stent system receives FDA approval
CeloNova BioSciences Inc. announced its novel first-in-class nanocoated coronary stent system has received FDA approval following the results of the of the PzF SHIELD clinical trial.
The stent (Cobra PzF), which is coated with a biocompatible proprietary nanothin polymer, requires a minimum 30-day dual antiplatelet therapy regimen after intervention, according to a press release issued by the company.
Biotronik announces FDA approval of ICD systems for patients with HF
Biotronik announced FDA approval of two implantable cardioverter defibrillator systems for the improvement of care for patients with HF, according to a press release.
The Intica DX and Intica cardiac resynchronization therapy (CRT)-DX ICD systems are cardiac rhythm management devices that eliminate the need for an atrial lead while providing physicians with critical diagnostic information based on a true atrial signal, according to the release.
Intra-aortic balloon pump receives FDA clearance for treatment of arrhythmias, elevated heart rate
Teleflex announced FDA clearance for an intra-aortic balloon pump for the treatment of patients with severe arrhythmias or heart rates up to 200 beats per minute, including those who were originally not candidates for the therapy.
The device (AC3 Optimus) delivers intra-aortic balloon pump therapy through an artery and into the aorta to assist in pumping blood. The console manages the inflation and deflation of the balloon. Algorithms in the device automatically regulate the timing and triggering of intra-aortic balloon pump therapy, according to a press release issued by the company.
Biotronik announces FDA approval, launch of three products for patients with heart failure, arrhythmias
Biotronik announced the launch of three products recently approved by the FDA: a quadripolar left ventricular lead, a technology to detect when a patient with a cardiac rhythm management device enters an MRI environment, and a pacing technology for patients with HF unresponsive to cardiac resynchronization therapy.
The quadripolar left ventricular lead (Sentus ProMRI) is the thinnest available in the United States and is approved for use with devices for patients with HF, according to a press release issued by the company.
Newest-generation self-expanding TAVR device receives FDA approval
Medtronic announced the FDA approved a new version of its self-expanding transcatheter aortic valve replacement system designed to improve valve sealing performance.
The valve (CoreValve Evolut PRO) is indicated for treating severe aortic stenosis in patients at high or extreme risk for open-heart surgery, according to a press release issued by the company.
Next-generation wireless insertable cardiac monitor receives FDA clearance
Medtronic announced the FDA clearance for a new version of its insertable cardiac monitor, designed to minimize the rate of false readings for patients with arrhythmia.
The cardiac monitor (Reveal LINQ with TruRhythm Detection) features updated algorithms that reduce inaccurate results including false bradycardia by 95% and false pause by 47%, compared with the predecessor device (Reveal LINQ), according to a press release.