Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] today announced positive clinical trial data for its Sphere-360 investigational pulsed field ablation (PFA) catheter technology. The single-shot mapping and ablation catheter uses pulsed field energy to treat patients with paroxysmal AFib. Medtronic presented interim findings on the … [Read more...] about Medtronic has positive data for single-shot mapping ablation catheter
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Medtronic has a serious catheter tubing recall
The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, 46915, … [Read more...] about Medtronic has a serious catheter tubing recall
Medtronic enrolls first patient in aneurysm repair trial
Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] announced today that it enrolled the first patient in the Hercules trial comparing abdominal aortic aneurysm repair methods. Hercules compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR). It looks at these methods in patients who have an abdominal … [Read more...] about Medtronic enrolls first patient in aneurysm repair trial
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
Catheter-based innovations we can’t stop thinking about
Catheter-based devices had their year in 2023. Medtech companies set their sights on improving patient care in cardiology, neurology and more. Our previous roundup of the top 10 most-read catheter-based news stories of 2023 wasn't enough for us. Medical Tubing + Extrusion's editors could not stop thinking about several other stories when … [Read more...] about Catheter-based innovations we can’t stop thinking about
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
What’s so special about pulsed field ablation? Medtronic EVP Sean Salmon explains
Medtronic’s PulseSelect Pulsed Field Ablation (PFA) System — which won the first FDA approval for PFA to treat atrial fibrillation (AFib) — is just the start of a wave of new PFA devices expected to hit the market. Medtronic is lining up another PFA cardiac ablation system for approval, while competitor Boston Scientific anticipates approval of … [Read more...] about What’s so special about pulsed field ablation? Medtronic EVP Sean Salmon explains
Medtronic PulseSelect pulsed field ablation wins FDA approval
The FDA has approved the Medtronic PulseSelect pulsed field ablation (PFA) system, the device developer said today. PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval. The minimally invasive, cardiac ablation system is indicated for the … [Read more...] about Medtronic PulseSelect pulsed field ablation wins FDA approval
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
After recall and relaunch, Medtronic wants to go global with its catheter-delivered Harmony valve
Each Medtronic Harmony valve is sewn by hand to attach laser-cut pig tissue to the nitinol that makes this minimally invasive heart implant possible. Medtronic’s Harmony transcatheter pulmonary valve (TPV) design is paying off after engineers solved a delivery catheter recall and relaunched the system this year. The Harmony TPV uses pig tissue, … [Read more...] about After recall and relaunch, Medtronic wants to go global with its catheter-delivered Harmony valve