Abbott Announces First Global Procedures in a Clinical Trial of its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms

Rhea-AI Summary

Abbott (ABT) announces the first global procedures using the Volt Pulsed Field Ablation (PFA) System to treat patients with atrial fibrillation. The system uses high energy electrical pulses to destroy cells causing abnormal heart rhythms, reducing the risk of damaging adjacent tissue. The Volt PFA System is designed to overcome limitations of first-generation PFA systems and provide a more accurate and efficient workflow for physicians.

Insights

Cardiologist

Abbott's introduction of the Volt™ Pulsed Field Ablation (PFA) System represents a significant advancement in the treatment of atrial fibrillation (AFib), a condition that affects millions worldwide. The PFA technology diverges from traditional radiofrequency and cryogenic ablations by employing electrical pulses, which may reduce collateral damage to adjacent heart tissue. This is crucial for patients with complex cardiac anatomies where precision is paramount.

From a cardiological perspective, the system's integration with the EnSite™ X EP System is noteworthy. This mapping technology is instrumental in enhancing the accuracy of ablation procedures. By enabling physicians to better visualize and position the ablation catheter, the potential for more effective and efficient treatments increases, which is particularly beneficial for patients with persistent or long-standing persistent AFib, where ablation success rates have historically been lower.

Moreover, the balloon-in-basket catheter design of the Volt PFA System could lead to improvements in lesion formation, an essential factor in the success of ablation therapy. The ability to create more precise lesions can contribute to a decrease in the number of required ablations, thus potentially shortening procedure times and reducing risks associated with longer exposure to invasive procedures.

Healthcare Industry Analyst

From an industry standpoint, the development of the Volt PFA System by Abbott is poised to impact the cardiac ablation market significantly. AFib is the most common type of serious heart rhythm abnormality in older adults and its prevalence is expected to increase with an aging population. As such, the demand for advanced treatment options like PFA is anticipated to grow.

The system's potential to reduce procedure times and improve patient outcomes could lead to increased adoption rates by healthcare providers, positioning Abbott favorably against competitors in the electrophysiology market. The strategic pairing of the Volt PFA System with the EnSite X mapping system could be seen as a move to create a more comprehensive product offering, which may enhance Abbott's market share and strengthen its brand equity in the electrophysiology space.

It is also important to consider the economic implications for healthcare systems. By potentially reducing the duration of hospital stays and the need for repeat procedures, the Volt PFA System could contribute to cost savings for both patients and healthcare providers, aligning with the broader industry trend towards value-based care.

Medical Device Regulatory Expert

The announcement of the first global procedures using the Volt PFA System also has regulatory implications. The system's ongoing CE Mark study and anticipated approval for a U.S. clinical trial (IDE) indicate progress in the regulatory pathway, which is a critical step towards commercialization in various markets.

Regulatory approvals are contingent upon demonstrating safety and effectiveness and the design of the Volt PFA System appears to address some of the limitations of first-generation PFA systems. If the clinical study outcomes are positive, this could facilitate a smoother regulatory process. However, it's important to remain cognizant of the rigorous scrutiny that medical devices undergo, particularly in the U.S. where the FDA's premarket approval process for Class III devices is stringent.

For stakeholders, the progression of Abbott's Volt PFA System through clinical trials and towards potential market entry is an indicator of the company's commitment to innovation in cardiac care. However, the actual impact on the business will depend on the system's clinical performance, market acceptance and the ability to navigate the complex regulatory environment.

• Abbott's Volt™ Pulsed Field Ablation System is designed to provide a new therapy option for people battling heart rhythm disorders such as atrial fibrillation
• Pulsed field ablation – or PFA – uses high energy electrical pulses for ablation procedures that may offer benefits to target and treat tissue in the heart
• Abbott's Volt PFA System is designed to overcome limitations of first-generation PFA systems by providing physicians a clearer indication of contact between the Volt PFA Catheter and targeted tissue

ABBOTT PARK, Ill., Jan. 18, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the first global procedures have been conducted using the company's new Volt™ Pulsed Field Ablation (PFA) System to treat patients battling common abnormal heart rhythms such as atrial fibrillation (AFib). Over 30 patients were recently treated in Australia as part of Abbott's Volt CE Mark study, a pre-market, multi-center clinical study designed to evaluate the safety and effectiveness of Abbott's Volt PFA System. In addition to upcoming procedures in markets across Asia Pacific and Europe, Abbott anticipates approval for its U.S. clinical trial (IDE) for the Volt PFA System in the first half of this year.

"We have long known that pulsed field ablation could open up an entirely new frontier in how we treat people battling the most complex cardiac arrhythmias. But like any innovation, early solutions have not been able to fully capitalize on those potential benefits," said Professor Prash Sanders, M.B.B.S., Ph.D., director of the Centre for Heart Rhythm Disorders at the University of Adelaide in Australia, who conducted the first procedures with the Volt PFA System. "Abbott has designed a novel PFA solution that, when combined with its EnSite X cardiac mapping system, can address hard-to-treat irregular heartbeats with a level of accuracy and precision that's never before been possible." 

Historically, patients requiring a cardiac ablation procedure to treat conditions like AFib received radiofrequency (RF) ablation, which uses heat to destroy tissue responsible for erratic heart signals, or cryogenic ablation, which freezes tissue. Instead of heat or extreme cold, PFA uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms, which can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy.

First-generation PFA systems have required multiple ablations with the catheter positioned in various locations to effectively treat targeted tissue.

Abbott's Volt PFA System addresses these limitations by pairing its balloon-in-basket catheter with Abbott's EnSite™ X EP System, an industry-leading heart mapping system that allows physicians to visualize and position tools like the Volt PFA Catheter in the heart. Volt's design can result in more accurate ablation procedures as it provides physicians a clearer indication to make improved contact with the targeted heart tissue due to the catheter's unique positioning, handling and steering. Its balloon feature allows for efficient energy transfer to tissue to improve how the catheter creates lesions to stop the heart's erratic signals.

The EnSite X mapping system's clear visualization guides physicians to precisely identify areas in the heart that require ablation, allowing for a more accurate position of the Volt PFA Catheter to treat tissue. The benefits of this degree of specificity are a more efficient workflow and reduced patient exposure to radiation.

"Daily life for the millions of people with AFib can be difficult as symptoms often include palpitations, shortness of breath, dizziness and chest pain, making it critical that physicians treat the issue as soon as possible," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "With AFib cases expected to rise continuously, Abbott's Volt PFA System meets a growing demand for a more innovative solution that reduces the patient procedure time and overall hospital stay, getting them back to living a fuller, longer life."

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

 

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SOURCE Abbott

FAQ

What is the purpose of Abbott's Volt Pulsed Field Ablation (PFA) System?

The purpose of Abbott's Volt PFA System is to treat patients with atrial fibrillation using high energy electrical pulses to destroy cells causing abnormal heart rhythms.

How many patients were recently treated using the Volt PFA System?

Over 30 patients were recently treated in Australia as part of Abbott's Volt CE Mark study.

What are the benefits of the Volt PFA System over first-generation PFA systems?

The Volt PFA System overcomes limitations of first-generation systems by providing a clearer indication of contact between the Volt PFA Catheter and targeted tissue, resulting in more accurate ablation procedures.

What is the role of Abbott's EnSite X mapping system in conjunction with the Volt PFA System?

The EnSite X mapping system allows physicians to visualize and position tools like the Volt PFA Catheter in the heart, resulting in more efficient workflow and reduced patient exposure to radiation.

Who conducted the first procedures with the Volt PFA System?

Professor Prash Sanders, M.B.B.S., Ph.D., director of the Centre for Heart Rhythm Disorders at the University of Adelaide in Australia, conducted the first procedures with the Volt PFA System.