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a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, reported it has submitted a 510(k) for approval of its patented Morph DNA Steerable Introducer Sheath. mtaschetta-millane Wed, 07/31/2024 - 07:00 July 31, 2024 — BioCardia, Inc. ,
A company statement reported that its PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e.,
Pulsed-field ablation (PFA) is becoming increasingly relevant in the field of electrophysiology. Besides single-shot PFA devices for pulmonary vein isolation (PVI), point-by-point PFA is also gaining importance due to many possible applications. Data on the use is sparse, especially for atrial tachycardia (AT).
Methods In this study, blood samples were collected from 16 patients before and 24h after pulmonary vein isolation (PVI) via a novel investigational PFA-based technology.
Patients in the study will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA System, or receive AAD treatment, and followed for three years. The randomized AVANT GUARD trial will enroll more than 500 patients diagnosed with persistent AF at up to 75 sites globally.
a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, announced the completion of the first five procedures in its first-in-human feasibility study with its novel CellFX nsPFA cardiac catheter.
Abstract Introduction Through systematic scientific rigor, the CLOSE guided workflow was developed and has been shown to improve pulmonary vein isolation durability. However, this technique was developed at a time when using power-controlled ablation catheters with conventional power ranges was the norm.
Abstract Background The newly introduced nonthermal pulsed field ablation (PFA) is a promising technology to achieve fast pulmonary vein isolation (PVI) with high acute success rates and good safety features. PFA versus VHPSD for PVI.
This study investigated myocardial injury and inflammation following pulmonary vein isolation using (1) Standard radiofrequency ablation, (2) very high-power short-duration (vHPSD)-70W, (3) vHPSD-90W, and (4) pulsed-field ablation (PFA). 001), HPSD-70W (Δ2.7 ± 1.7 × 10 9 /L, p = .037), 037), and HPSD-90W (Δ3.6 ± 2.5 × 10 9 /L, p < .001).
This study aims to identify factors leading to insufficient lesions during pulmonary vein antral isolation (PVAI) with vHPSD-ablation and to develop an optimized PVAI strategy using this technology. Abstract Purpose Very high-power short-duration (vHPSD) ablation creates shallower lesions, potentially reducing efficacy.
Abstract Introduction Despite advanced ablation strategies and major technological improvements, treatment of persistent atrial fibrillation (AF) remains challenging and the underlying pathophysiology is not fully understood. First, high-density mapping (78% biatrial) with a multipolar mapping catheter was performed.
The trial showed the Volt PFA System achieved pulmonary vein isolation (PVI) the method of destroying tissue causing a patient's AFib in 99.1% The One System Solution provided by EnSite X can accommodate all EP procedures and compatible technologies. chief medical officer of Abbott's electrophysiology business.
Despite advances in catheter ablation technology, persistent AF remains one of the most challenging subtypes of atrial fibrillation to treat, affecting over 70% of all patients with atrial fibrillation globally. tim.hodson Fri, 02/14/2025 - 09:57 Feb. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S.
Recent technological advancements, such as catheter design and energy delivery, can pave the way for the wider adoption of PFA in clinical practice to improve patient outcomes. Pulmonary vein isolation (PVI) procedure, left atrial dwell, and fluoroscopy times were 51, 32, and 12 minutes, respectively.
Volta Medical has announced it has entered into a Joint Development Agreement with GE Healthcare to enhance arrhythmia procedures with artificial intelligence (AI)-driven electrophysiologytechnologies. Our mission to combat complex heart rhythm diseases relies on optimizing interoperability.
This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformité Européenne) Mark of the PulseSelect PFA system in November. This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformité Européenne) Mark of the PulseSelect PFA system in November.
“The entire digital electrocardiogram signal performed significantly better than a few of its components,” said Chugh, who is also the Pauline and Harold Price Chair in Cardiac Electrophysiology Research and associate director in the Smidt Heart Institute. “We
By the 1960s, advances in technology and medical research led to the emergence of automated ECG interpretation (AEI), based on physician-developed rules of classification. By 1909 ECGs were being used to diagnose cases of arrhythmia; by 1910 to diagnose indicators of a heart attack.
2** Furthermore, the primary effectiveness endpoint (PEE) of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, Atrial Tachycardia, or Atrial Flutter) was 75.6%. 4 “At Biosense Webster, we continually seek to push the boundaries of science and technology innovation in cardiac ablation.
ABSTRACT Introduction Pulmonary vein isolation (PVI) using a cryoballoon is well-established for the treatment of paroxysmal atrial fibrillation (PAF). Compared to other available technologies, the usage of a stable, low-pressure cryoballoon (POLARx, Boston Scientific) has demonstrated lower nadir temperatures and longer thawing times.
Abstract Introduction Pulsed field ablation (PFA) is a new ablation technology for atrial fibrillation (AF). Data regarding early recurrences of atrial tachyarrhythmia (ERAT) after PFA-pulmonary vein isolation (PVI) are sparse. We found no difference in the rate of LRs among patients experiencing ERAT before or after 45 days.
Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn Mount Sinai. These ablation modalities are associated with increased risk of potential complications, including damage to the esophagus, pulmonary vein stenosis, and injury to the phrenic nerve, which controls the diaphragm and is essential for breathing.
Boston Scientific made what could become a major addition to its electrophysiology portfolio, acquiring AFib mapping startup Cortex, Inc. Cortex gives Boston Scientific a new mapping technology that detects AFib signs and triggers outside of the pulmonary veins, and can help EP teams develop ablation strategies for more complex AFib cases.
With this approval, Medtronic now offers two PFA technologies available for patients with Afib. The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. tim.hodson Wed, 10/30/2024 - 13:42 Oct.
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