Abbott's Second-Generation PFA System: CMO Christopher Piorkowski Details the Rationale Behind the Balloon Design

Feb 15, 2024 18:05 CST Updated 18:05

Abbott

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Source of the article: Heart Future; Editor:Liu Xinyi

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Heart Future

Recently,AbbottChristopher Piorkowski, Chief Medical Officer of Electrophysiology, on Abbott's newly launchedPulsed Electric Field Ablation System Volt™ SystemShared more details, focusing on the systemBalloonThe Design Intention。

# Why Design a Balloon?

Compared with Medtronic's PulseSelect system and Boston Scientific's FARAPULSE system, Abbott's Volt™ Pulsed Field Ablation System not only features an advanced mapping system but also...There is another one on the catheter.Unique Design——Balloon。

▲ Volt PFA catheter

The ablation catheter tip of the Volt™ system isBasket-like, Basket has8 Branches, which contains aExpansion BalloonAbbott said, "Generally speaking,The design of the balloon is for the process of ablation.Apply energy to the target location more effectively, therebyImprove the accuracy, quality, efficiency, and frequency of ablation while reducing potential side effects.。

Deep Ablation：Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology division, said in an interview: "Our data shows that the inclusion of the expanded balloonThe baskets included and the baskets not included causedThe ablation depth will vary by 20% to 30%.. From our workbench and animal testing data, Volt™Long-term ablation depth can reach 6 to 8 millimeters.. This depth is sufficient for the ablation of the left atrium and pulmonary vein isolation.。”

▲ Christopher Piorkowski

At the same time, to complement the design of the balloon and further maximize the efficiency of energy transfer to the cardiac tissue, the Volt™ catheterThe electrode is flat rather than round.，Only facing the outer side of the balloon。

Reduce Bubbles: In addition, the balloon is an insulator inside the patient's beating heart.Can reduce the formation of bubbles，Avoid Gas EmbolismCompared with radiofrequency ablation, pulsed field ablation (hereinafter referred to as PFA) has significantly reduced the risk of gas embolism because it relies on irreversible electroporation rather than thermal effects to affect cells. However, current research also indicates that, due toPFA may produce diffused bubbles due to electrolysis reactions, and there is also a risk of causing gas embolism.。

Dr. Piorkowski said, "In the early days of the PFA era, few people talked about the issue of bubbles. When we were designing clinical trials, we held many pre-submission meetings with the FDA. At that time, we discussed the design of the trial, what they considered important, and the issues we should address. Then we talked about the problem of bubbles."We must address the issue of bubbles in preclinical testing and trial design.。”

Dr. Piorkowski also indicated that, compared with similar PFA devices, the Volt™ systemLower ablation voltage, soThe risk of generating thermal effects is also lower.However, the doctor said that the voltage used by the Volt™ system will not be disclosed for the time being, nor will the difference be quantified.

High Efficiency and Convenience: The balloon also helpsWithin the pulmonary veinStable Basket. During the procedure, because the catheter head is round, doctors can easily deliver the catheter to the ablation site, and with just a slight rotation, another basket branch can be used to start the second ablation. Currently, during testing, doctors perform three to four ablations per treatment. Dr. Piorkowski commented on this: "Such...ConsumptionThe number of fusions is much lower than the PFA technology currently used in clinical practice.。”

# Tissue Contact Assessment

Another unique feature of the Volt™ system isTissue Contact Assessment。The energy delivery of the PFA system depends on tissue contact., so the doctor needs to know when the electrode will directly contact the tissue during ablation. To achieve this, Abbott's engineers adopted a technology invented by the company for previous ablation catheters.Impedance-Based Measurement Method, and applied it to each electrode of the Volt™ catheter.

Dr. Piorkowski said, "We quickly saw the advantages of such a design in laboratory testing and clinical applications. Our PFA systemTissue contact assessment is performed not on a single electrode but on all 8 splines of the basket.。”

# Future Plans

The company stated that it hopes to obtain FDA's IDE (Investigational Device Exemption) clinical trial in the first half of 2024. This trial includes patients with paroxysmal and persistent atrial fibrillation (AFib). If the trial is successful, Abbott's Volt™ systemAs early as 2026, it will receive FDA approval.(Two years earlier than the 2028 estimate by analysts).

Dr. Piorkowski said, "There will certainly be risks ahead of us, but we will act as soon as possible... Currently, many people are eager to participate in our trial recruitment, and weThe recruitment speed is really fast, andThirty patients have been successfully treated in Australia. These patients will undergo a mid-term assessment for safety and efficacy. The data from the evaluation is directly related to when we will begin the IDE trial.

# About Abbott

Abbott/Abbott(New York Stock Exchange: ABT)Founded in 1888, with its headquarters located in Chicago, USA. After a century of development, the company has now become a diversified Fortune 500 enterprise and is an international healthcare company. Abbott's businesses are divided intoPharmaceuticals, Nutritional Products, Diagnostics, Medical DevicesFour categories. Among themMedical DeviceFurther divided intoSubcategories such as heart rate management, electrophysiology, heart failure, vascular, structural heart, neuromodulation, and diabetes。

As announced by AbbottQ4 2023 Earnings Report and Full-Year Performance:

Annual revenue for 2023 was $40.11 billion, a decrease of 8.1% year-on-year; revenue in the fourth quarter was US$10.24 billion, an increase of 1.5% year-on-year;
2023Annual net profit is $5.72 billion, a decrease of 17.5% year-on-year; net profit in the fourth quarter was US$1.59 billion, increasing by 54.2% year-on-year;
Medical device business saw the most significant growth in 2023, with annual sales reaching $16.89 billion, representing a year-on-year increase of approximately 14%., whereinDiabetes care grows fastest (22.1%), followed by neuromodulation (15.5%), and then electrophysiology (13.9%);
Full-year organic sales growth (excluding sales related to COVID-19 testing) for fiscal year 2024 is expected to be between 8.0% and 10.0%.

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