Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program
The U.S. Food and Drug Administration (FDA) updated the Breakthrough Device Program designations data this week, which now includes 1,176 designations, of which 160 have gained market clearance.
Cardiovascular devices lead these with 243 devices, the highest number out of all other clinical categories. This includes 16 cleared in the past year.
Devices are eligible for Breakthrough Device designation if they represent breakthrough technology, no approved alternatives exist, they offer significant advantages over existing cleared alternatives and rapid device availability is in the best interest of patients. The device also needs to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.
The FDA said the voluntary program also speeds up the regulatory review process while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorizations. The FDA created the program in 2018 as a way to expedite approval of promising new technologies that would likely have a major impact on patient care.
The updated FDA list of approvals from the past year include several breakthrough cardiology technologies, including:
• TriClip G4 System, Abbott, for transcatheter tricuspid valve repair.
• Farapulse Pulsed Field Ablation System (FaraWave), Farapulse, for catheter cardiac ablation to treat atrial fibrillation with irreversible electroporation.
• Esprit Below-the-Knee (BTK) Everolimus Eluting Resorbable Scaffold System, Abbott, biosorbable scaffold to treat peripheral artery disease in the infrapopliteal vessels.
• Tendyne Transcatheter Mitral Valve System, Abbott, transcatheter delivered mitral valve.
• Evoque Tricuspid Valve Replacement System, Edwards Lifesciences, transcatheter delivered tricuspid valve.
• Eko Low Ejection Fraction Tool (ELEFT), Eko Health, automated software augmentation of stethoscope to aid clinicians in identifying left ventricular ejection fractions (LVEF) less than or equal to 40% using an ECG and heart sounds.
• Da Vinci X Surgical System, Intuitive Surgical, cleared for numerous minimally invasive surgical procedures, including thorascopically-assisted cardiotomy.
• Spur Peripheral Retrievable Stent System, Reflow Medical, peripheral temporary and retrievable stent system.
• Agent Paclitaxel-Coated Balloon Catheter, Boston Scientific, drug-eluting percutaneous transluminal coronary angioplasty catheter.
• InVision Precision Cardiac Amyloid, InVision Medical Technology, automated AI screening tool for adult patients undergoing echocardiography to help interpreting physician identify cardiac amyloid.
• WiSE (Wireless Stimulation of the Endocardium Technology) leadless cardiac resynchronization therapy, EBR Systems.
• ViaOne Epicardial Access System, CardioVia, to access the epicardial surface of the heart via a subxiphoid approach to deliver diagnostic and therapeutic interventions for ventricular tachycardia.
• Gore Excluder Thoracoabdominal Branch Endoprosthesis, W.L. Gore & Associates, endovascular system for treatment of thoracoabdominal and pararenal aortic lesions.
• EchoGo Amyloidosis, Ultromics, AI adjunctive cardiac amyloidosis status indicator on echocardiography exams.
• ShortCut, Pi-Cardia, a percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures.
• Minima Aortic Stent System, Renata Medical.
Previously cleared breakthrough cardiology devices from this program include the Shockwave Intravascular Lithotripsy (IVL) System, the Medtronic Harmony Transcatheter Pulmonary Valve (TPV), Medtronic and Recor renal denervation systems, Ultromics EchoGo AI to detect heart failure on ultrasound, Abbott's Aveir leadless pacemaker, Impulse Dynamics Optimizer Smart System, Caption Health's AI cardiac ultrasound image acquisition, the LimFlow bypass system for peripheral artery disease, and the CVRx Barostim Neo System carotid sinus nerve stimulator for improvement of heart failure symptoms.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]