One component stands out as unique when you compare the Abbott Volt against competing pulse field ablation (PFA) systems from Medtronic and Boston Scientific. The Volt cardiac ablation catheter has a balloon, something you won’t see on Medtronic’s PulseSelect PFA catheter — the first of its kind approved by the FDA — or the Farawave catheter in … [Read more...] about Abbott bets on balloons in pulse field ablation battle
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The worst catheter-based device recalls of 2023
The U.S. saw seven severe catheter-based device recalls in 2023, according to the FDA's medical device recall database. The agency in 2023 tagged 61 medical device recalls as Class I — the most serious level. For comparison, the FDA recalled 60 devices in 2022, of which four were related to catheter-based devices. Last year, the most serious … [Read more...] about The worst catheter-based device recalls of 2023
The 10 most-read catheter-based innovation stories of 2023
This year was a year of firsts for catheter-based innovations, most notably for renal denervation and pulsed field ablation. ReCor Medical won an FDA panel nod for its renal denervation system in August. The panel voted in favor of the safety and efficacy of its Paradise ultrasound renal denervation (RDN) system for treating hypertension. The … [Read more...] about The 10 most-read catheter-based innovation stories of 2023
The biggest cardiovascular stories from TCT 2023
Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT. This year's 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco. Usual suspects like Medtronic and Abbott had data on display for a range of products, while other big … [Read more...] about The biggest cardiovascular stories from TCT 2023
Abbott has positive data for Esprit drug-eluting resorbable scaffold
Abbott today announced data supporting its Esprit BTK everolimus-eluting resorbable scaffold system. The company designed Esprit BTK to treat people with chronic limb-threatening ischemia (CLTI), a severe stage of peripheral artery disease (PAD). Abbott said its LIFE-BTK trial met both of its primary safety and effectiveness endpoints. It … [Read more...] about Abbott has positive data for Esprit drug-eluting resorbable scaffold
Abbott has a serious recall involving its Amplatzer delivery sheath
The FDA today said an Abbott recall involving its Amplatzer steerable delivery sheath is Class I, its most serious level. Launched in the U.S. in April 2022, the Amplatzer sheath delivers Abbott's Amplatzer Amulet left atrial appendage occluder. Competing against Boston Scientific's Watchman, Amplatzer Amulet provides complete occlusion in order … [Read more...] about Abbott has a serious recall involving its Amplatzer delivery sheath
FDA approves Surmodics SurVeil drug-coated balloon
Surmodics (Nasdaq:SRDX) announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota–based Surmodics may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal … [Read more...] about FDA approves Surmodics SurVeil drug-coated balloon
The top catheter innovation news stories of 2023 — so far
The world of catheter innovation has already seen remarkable strides this year— with some of the most promising medtech delivered into the body via catheter-based procedures. Think of improved ablation for treating AFib, coronary intravascular lithotripsy to combat coronary artery disease, and more. Here, we've highlighted the top five … [Read more...] about The top catheter innovation news stories of 2023 — so far
Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Abbott (NYSE: ABT) today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world's first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott's EnSite X EP System, enabling physicians to visualize heart anatomy more … [Read more...] about Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Abbott reports positive data for TriClip TEER system
Abbott this week announced late-breaking data supporting the benefits of its TriClip transcatheter edge-to-edge repair (TEER) system. The company presented study data at EuroPCR in Paris. This study evaluated TriClip, a first-of-its-kind, minimally invasive device, in treating patients with leaky tricuspid valves. Abbott’s bRIGHT study … [Read more...] about Abbott reports positive data for TriClip TEER system
