The FDA has approved the balloon-expandable Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis. This is the first time the agency has approved any TAVR technology to be used in asymptomatic patients. The FDA has approved the balloon-expandable Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis. This is the first time the agency has approved any TAVR technology to be used in asymptomatic patients. | | |
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Philippe Genereux, MD, principal investigator of EARLY TAVR, presented new data at ACC.25 showing intervening early on crossover patients with asymptomatic severe aortic stenosis led to better outcomes and a reduced stroke rate. Philippe Genereux, MD, principal investigator of EARLY TAVR, presented new data at ACC.25 showing intervening early on crossover patients with asymptomatic severe aortic stenosis led to better outcomes and a reduced stroke rate. | | |
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The newly approved device can be worn for up to a week at a time, with no daily maintenance required, and includes advanced AI algorithms that minimize the risk of false alarms or inappropriate shocks. The newly approved device can be worn for up to a week at a time, with no daily maintenance required, and includes advanced AI algorithms that minimize the risk of false alarms or inappropriate shocks. | | |
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New TAVR data on SAPT vs. DAPT and prosthesis-patient mismatch among women were some of the many highlights of the conference's opening day. New TAVR data on SAPT vs. DAPT and prosthesis-patient mismatch among women were some of the many highlights of the conference's opening day. | | |
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The study's authors reviewed CCTA imaging results taken before and after radiotherapy, evaluating each image for signs of coronary calcification and inflammation. The study's authors reviewed CCTA imaging results taken before and after radiotherapy, evaluating each image for signs of coronary calcification and inflammation. | | |
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Patient outcomes do not appear to be negatively impacted by these risks, researchers noted. The new data were presented at Heart Rhythm 2025 and published in JACC: Clinical Electrophysiology. Patient outcomes do not appear to be negatively impacted by these risks, researchers noted. The new data were presented at Heart Rhythm 2025 and published in JACC: Clinical Electrophysiology. | | |
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An advanced preservation system from Paragonix, a Getinge company, was linked to dramatic reductions in both mortality and procedural complications. An advanced preservation system from Paragonix, a Getinge company, was linked to dramatic reductions in both mortality and procedural complications. | | |
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A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time. A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time. | | |
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The 55-year-old patient woke up experiencing chest pain one morning and an ambulance was called. He was dead just a few hours later. His family's lawsuit argued that delays in care, communication errors and other issues were directly responsible for his death. The 55-year-old patient woke up experiencing chest pain one morning and an ambulance was called. He was dead just a few hours later. His family's lawsuit argued that delays in care, communication errors and other issues were directly responsible for his death. | | |
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“The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload." “The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload." | | |
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Despite newly implemented tariffs, the manufacturer says it was profitable in Q1 of 2025, but a greater impact on its operations looms later this year. Despite newly implemented tariffs, the manufacturer says it was profitable in Q1 of 2025, but a greater impact on its operations looms later this year. | | |
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The company cited declining enrollment as the reason for exiting the exchanges, including from patients seeking Medicare options. The company cited declining enrollment as the reason for exiting the exchanges, including from patients seeking Medicare options. | | |
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