FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy
The U.S. Food and Drug Administration (FDA) has approved Myqorzo® (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), denoting a major advancement in targeted pharmacologic management of this complex structural heart disease. Obstructive hypertrophic cardiomyopathy is a genetic myocardial disorder characterized by pathologic thickening of the ventricular myocardium, most notably involving…
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Robotic-Assisted Mitral and Revascularization Procedures: Expanded FDA Clearance for da Vinci 5
Intuitive Surgical’s da Vinci 5 system has received expanded FDA 510(k) clearance for selected minimally invasive cardiac procedures, including mitral valve repair and coronary revascularization applications. From a clinical standpoint, this clearance supports the continued evolution of robotic-assisted cardiac surgery, particularly in procedures requiring high precision within confined operative fields. The platform’s advanced visualization, refined…
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FDA Expands Indication for Medtronic Evolut™ TAVR Systems
The FDA has approved Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) systems to be used in Redo TAVR procedures. This means patients who previously received a transcatheter valve and are now experiencing valve failure have a minimally invasive option instead of undergoing open-heart surgery. The expansion of this indication reflects the growing need for lifetime…
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BiVACOR’s Total Artificial Heart Earns FDA Breakthrough Status
On June 2, 2025, the FDA granted Breakthrough Device status to the BiVACOR Total Artificial Heart (TAH)—a next-generation fully implantable heart replacement system. What sets BiVACOR apart is its magnetically levitated pump, which allows for precise, continuous blood flow without the need for valves or diaphragms. The compact design is intended to serve as a…
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A Wearable Lifeline: FDA Clears Jewel Patch Defibrillator for At-Risk Patients
The U.S. Food and Drug Administration (FDA) has approved the Jewel® Patch Wearable Cardioverter Defibrillator (Patch-WCD), developed by Element Science. This next-generation wearable defibrillator is specifically designed for adults at risk of sudden cardiac arrest who either aren’t eligible for or choose not to receive a traditional implantable defibrillator. Its patch-based form factor provides continuous…
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FDA Approves Expanded Use of SAPIEN 3 Ultra RESILIA Valve System
FDA has approved the expanded use of the Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System. Initially designed for aortic valve replacement, this advanced valve system is now indicated for the replacement of failing surgical biological mitral valves in patients who are at intermediate or higher risk for open-heart surgery. This represents a significant…
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Pulse Biosciences’ Cardiac Surgery System Receives FDA Breakthrough Device Designation
The Pulse Biosciences CellFX® Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System has been granted FDA Breakthrough Device Designation, recognizing its potential in treating atrial fibrillation (AF) using a non-thermal ablation approach. Unlike traditional thermal ablation methods, which rely on extreme heat or cold, this system applies nanosecond-duration, high-amplitude electrical pulses to create precise lesions…
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FDA Approval of Attruby (Acoramidis) for Transthyretin-Mediated Cardiomyopathy
The FDA approved Attruby, a drug that targets the transthyretin protein and stabilizes it to prevent additional misfolding and deposition within cardiac tissues. This mechanism treats the underlying cause of the disease, making it an interventional approach that both slows disease progression and improves survival.Data from clinical trials showed that Attruby significantly reduced hospitalization and death associated…
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U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients
U.S. Food and Drug Administration (FDA) has expanded the indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps, granting premarket approval (PMA) for use in specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. The updated FDA indication for the use of Impella CP with SmartAssist: The Impella CP with…
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Teleflex receives FDA 510(k) clearance of the Ringer™ Perfusion Balloon Catheter
Teleflex announced that the FDA has granted 510(k) clearance for the company’s Ringer perfusion balloon catheter for percutaneous transluminal coronary angioplasty (PTCA), the only commercially available Percutaneous Transluminal Coronary Angioplasty perfusion balloon. The Ringer Perfusion Balloon Catheter will enter a limited market release phase in August 2024.The Ringer™ PBC is indicated for balloon dilatation of…
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FDA Advises Healthcare Facilities to Transition Away from Getinge’s Heart Devices Due to Safety Concerns
The U.S. Food and Drug Administration (FDA) has issued a recommendation urging healthcare facilities to discontinue the use of Getinge’s heart devices, including the Cardiohelp system and HLS Sets, as well as the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. This advisory comes in response to ongoing safety and quality concerns despite multiple…
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FDA Approves Two Gene Therapies for Sickle Cell Disease
The U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for treating sickle cell disease (SCD) in patients 12 years and older.Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. It is most common in African Americans and,…
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