Esophageal Perforation

Designed to leverage tissue-selective, non-thermal electric fields to ablate heart tissue, the Farapulse PFA System is indicated for the isolation of pulmonary veins during the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (AF) The Farapulse PFA System is indicated for the isolation of pulmonary veins. (Credit: Boston Scientific) US-based medical device manufacturer Boston Scientific has received the US Food and Drug Administration (FDA) approval for its Farapulse pulsed field ablation (PFA) System. The Farapulse PFA System is designed to deliver pulsed field energy, optimise cardiac PFA therapy, and provide a simplified user experience. It is indicated for the isolation of pulmonary veins during the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (AF). The PFA System primarily contains three components, the Farawave Ablation Catheter, the Farastar Ablation Generator, and the Faradrive Steerable Sheath. The Faradrive Steerable Sheath is complemented by the VersaCross Connect Access Solution to provide safe and effective access to the left side of the heart during procedures. The Farawave Ablation Catheter treats a range of PV anatomies using an over-the-wire catheter with variable basket and flower shapes, allowing the device to conform with patient anatomies. Also, the Farastar PFA Generator is designed to prepare, confirm, and deliver the therapy using bipolar and biphasic waveforms with unique pulses. The Farapulse PFA System is a new alternative to standard-of-care thermal ablation treatment, and its configurations promote reproducible procedures between operators, said the medical device manufacturer. Boston Scientific electrophysiology president Nick Spadea-Anello said: “The approval of the FARAPULSE PFA System marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S. “A high bar has been set by the performance of the system in clinical and commercial settings – where more than 40,000 patients have been treated to date – and we look forward to continuing to lead the way with this differentiated technology in the growing PFA space.” In a traditional ablation procedure, a catheter is guided to the interior of the heart to generate extremely high or low temperatures to destroy areas associated with abnormal heart rhythms. Boston Scientific said that its Farapulse PFA System will leverage tissue-selective, non-thermal electric fields to ablate heart tissue, preventing any damage to the surrounding structures. The system has been evaluated in the ADVENT clinical trial, the first randomised clinical trial to directly compare the efficacy and safety of the system against standard-of-care ablation, In the study, Farapulse showed comparable safety and effectiveness as conventional thermal ablation, with shorter ablation times and a faster learning curve for physicians. Also, data from the MANIFEST-17K registry showed continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or oesophageal injury. In 2019, Farapulse secured the Breakthrough Device Designation from the FDA’s Centre for Devices and Radiological Health (CDRH), followed by CE Mark in 2021. With the FDA approval now granted, Boston Scientific plans to immediately commercialise the system in the US. Furthermore, the company is developing a navigation-enabled version of the Farawave catheter alongside the Faraview Software Module, targeting their regulatory approval in 2024.

The ensoETM is a single-use thermal regulating device placed in the oesophagus and connected to an external heat exchange unit to reduce the chances of ablation-related oesophageal injury due to cardiac ablation procedures The ensoETM is a single-use thermal regulating device. (Credit: Business Wire) US-based medical device company Attune Medical has secured the US Food and Drug Administration (FDA) De Novo marketing authorisation for its ensoETM device. The ensoETM is a single-use thermal regulating device intended to reduce the chances of ablation-related oesophageal injury due to radiofrequency cardiac ablation procedures. It is placed in the oesophagus and is connected to an external heat exchange unit to create a closed-loop system that facilitates proactive controlled temperature management. Last year, the medical device company secured the FDA investigational device exemption (IDE) for the ensoETM device, in this indication. Attune Medical CEO Jay Istvan said: “Over the last 20 years, significant resources have been committed to mitigating serious oesophageal complications, with no meaningful results. “This De Novo marketing authorisation opens the door to a new standard. Studies have shown improved safety and efficacy for patients while allowing improved efficiency for physicians and greater cost savings for the hospitals in which they operate.” According to Attune, in the last two decades, commonly available technologies for mitigating complications have failed to reduce the risk of severe oesophageal injuries. Its ensoETM has been approved since 2015, for controlling patient temperature, and more than 50,000 patients have been treated with the device, said the medical device company. The FDA authorisation is based on pre-clinical studies, computer models, three randomised controlled studies, and data from thousands of patients treated in real-world uses. The clinical trials, including the eCOOL-AF pilot study, the IMPACT study, and a large multi-centre analysis of more than 25,000 patients, have examined the use of ensoETM. In the studies, the device showed up to an 83% reduction in oesophageal injuries, and a significant reduction in the risk of atrio-oesophageal fistula, a serious complication of ablation. Texas Cardiac Arrhythmia electrophysiologist Jason Zagrodzky said: “Historically, there have been no proven strategies to prevent oesophageal injury during ablation procedures, and injury rates have not declined despite the use of temperature probes. “This de novo authorisation gives electrophysiologists a solution to proactively cool the oesophageal wall during ablation procedures and is a great leap forward in best practice standards and patient care. “We have found a 35% reduction in fluoroscopy requirements with cooling, as well as a reduced staff workload which results in significant cost savings to hospital systems.”

The Centers for Disease Control and Prevention estimates more than 12 million people in the U.S. will be diagnosed with atrial fibrillation in 2030—and developers of heart ablation procedures have been seeking ways to minimize potentially harmful side effects. The FDA has granted a de novo clearance to a small, vacuum-powered catheter designed to take hold of a patient’s esophagus and gently move it out of the way during cardiac ablation procedures aimed at treating atrial fibrillation. One of the most common irregular heart rhythms, affecting millions of people in the U.S., afib is frequently treated by delivering thermal ablation within the heart’s left atrium. However, that heat energy can travel outside of the beating cardiac muscle—and with the esophagus only separated from the outer wall of the atrium by a thin layer of fat, unintended damage to the organ can lead to long-term and potentially deadly complications. S4 Medical’s solution is the Esolution, an esophagus-retracting catheter that is inserted into a patient’s mouth and down their throat. The device, developed first at The Ohio State University, uses suction at its tip to hold onto the organ from the inside, then curves to physically keep the esophagus away from the energy source. The company’s previous studies using animals have shown that by moving it to the side by about 20 mm or more, temperature changes in the walls of the esophagus can be kept under 0.2 degrees Celsius during high-power ablation. S4 Medical’s clinical study in humans was stopped early last year after the trial successfully met its primary goal ahead of schedule, by reducing the number of esophagus injuries compared to standard ablation procedures by 84%.  The Centers for Disease Control and Prevention estimate that more than 12 million people in the U.S. will be diagnosed with afib in 2030—and developers of heart ablation procedures have been seeking ways to minimize potentially harmful side effects. One of those methods includes developing pulsed field ablation—a next-generation technique being worked on at Boston Scientific, Medtronic and Johnson & Johnson’s Biosense Webster division—which uses tuned electric fields to target the heart’s contracting muscle cells, while avoiding damage to more-resistant nerve cells and nearby tissues such as the esophagus.