Medtronic (NYSE:MDT) today announced positive findings from a secondary analysis of the PULSED AF study for its pulsed-field ablation technology. The analysis demonstrated positive results for the PulseSelect system, including atrial arrhythmia (AA) burden reduction. This correlated to both improved quality of life and decreased healthcare utilization. Medtronic said in a news release that 87% […]
pulsed-field ablation (PFA)
Pulse Biosciences enters $65M private placement for pulsed-field ablation tech
Pulse Biosciences (Nasdaq:PLSE) announced today that it entered into a stock purchase agreement to raise approximately $65 million. Hayward, California-based Pulse Biosciences entered into the agreement with Robert Duggan, the company’s executive chair. Duggan agreed to purchase 10,022,937 shares of the company’s common stock at $6.51 per share. That marks a greater than 1% premium […]
Medtronic wins CE mark for Affera ablation system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system. The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates atrial arrhythmias — including AFib — and provides […]
Medtronic pulsed-field ablation system exceeds safety goal in study
Medtronic (NYSE:MDT) announced today that its PulseSelect pulsed-field ablation (PFA) system exceeded its safety performance goal in a clinical trial. PulseSelect registered an adverse event rate of 0.7%. Medtronic said that marks one of the lowest adverse event rates of any previous FDA investigational device exemption (IDE) trial for AFib ablation or any multi-center PFA […]
The top 10 cardiac device stories of 2022
From pulsed-field ablation to noninvasive monitoring, this was an exciting year for cardiac device tech. Here are the top 10 cardiac device stories from MassDevice and its sister sites: 10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio Earlier this year, Acutus agreed to sell its left-heart access portfolio to […]
Farapulse founder’s Field Medical partners with CardioNXT on novel pulsed-field ablation tech
Field Medical and CardioNXT announced a strategic collaboration to provide what they say is a first-of-its-kind pulsed-field ablation (PFA) therapy. The two companies plan to provide a purpose-built PFA therapy integrated with 3D mapping and navigation. According to a news release, both teams bring decades of experience in pioneering novel PFA and navigation technologies. Their […]
Medtronic completes enrollment in pulsed-field ablation catheter trial
Medtronic today announced it completed enrollment and final treatment in the Sphere Per-AF pivotal trial to study Affera’s pulsed-field ablation catheter tech. The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with the Affera cardiac mapping and […]
What is pulsed-field ablation? Here’s what you need to know
Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston. Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation is treated. PFA’s roots go back to the dc ablation tech of the 1980s. These days, PFA […]
What is the future of cardiac ablation?
Pulsed-field ablation (PFA) — a non-thermal method for cardiac ablation — has the potential to positively disrupt the atrial fibrillation market. Amid the excitement around the technology, Medtronic announced in January that it would acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. Meanwhile, Boston Scientific in February closed its $1.75 billion […]
