Medical diagnostics

Keeping a pulse on the EP market

Experts predict an evolution in electrophysiology with new technologies in pulsed field ablation hitting the market in 2024.
Prepare your healthcare organization by working with Vizient to build a strategy now.

 

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What is pulsed field ablation?

Pulsed field ablation (PFA) is a nonthermal ablative modality that uses a short-living, strong electrical field created around a catheter to create microscopic pores in cell membranes (electroporation).

When adequately dosed or configured it shows a preference for myocardial tissue necrosis. Thus, it holds a promise to become a perfect energy source for cardiac ablation to treat arrhythmias.

Clinical trial results, FDA approvals*, capital requirements, and reimbursement considerations all culminate in a complex landscape.

We are closely monitoring the progress of PFA and the suppliers who are racing to market. In the coming months, we will update this page with articles, podcasts and webinars to help healthcare providers gain insight into how these important changes may impact future care pathways for cardiac patients, to share best practices when adopting the new technology, and to explore strategic considerations when partnering with medical device suppliers in this dynamic environment.

Here are the top 10 questions our team is fielding from organizations looking to adopt the new technology.

*The status of FDA approval should be confirmed prior to engaging in a commitment agreement for capital or disposables. CFR21.812.7 prohibits suppliers from promoting or marketing a device until after FDA has approved it for commercial distribution.

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12M

Within 10 years,
more than 12 million Americans
will be diagnosed with
atrial fibrillation.

Vizient actively supports members in emerging technology adoption, such as PFA. It could revolutionize electrophysiology programs; and we are here to help our members prepare for the impact to current practice.
Sherri Mason, MSN, BSN, APRN, FNP-C Consulting Director, Vizient

FAQs

Your questions answered

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When will pulsed field ablation be available?

Most suppliers have participated or are participating in clinical trials. Medtronic and Boston Scientific are closer to completion and FDA submissions. Commercialization targets were originally anticipated at the end of 2023. Now it appears to be early to mid-2024.

NOTE: there are no FDA-approved PFA systems currently.

How can I best prepare for this new technology to ensure readiness for when it becomes available?

Speak with physician providers about their desire to bring this technology into the practice, anticipated timelines, budget constraints, and purchasing strategies

Can you provide examples of feedback you’ve heard so far in anticipation of PFA technology?

Hospitals are excited about the safety, outcomes, and efficiencies this brings to the practice and are eager to learn more. Most see PFA as revolutionary technology and would like to integrate it into their practice shortly after FDA approval.

Are there both capital equipment and disposables?

Yes.

How can I bring this into the practice with capital budget constraints?

Industry is looking at creative ways to help hospitals finance capital purchases. Approach considerations could include leasing, pay ahead type programs via other clinical supplies, and disposable allocation.

Are there any changes to reimbursement?

There are no expected changes to reimbursement.

How does this shorten procedures?

Time to treat the tissue is shorter due to the energy waves utilized in PFA versus current modalities. Clinical trials showed shorter procedure times (one hour with 12 minutes of fluoro time).

What does the safety profile look like comparing to radiofrequency or cryo ablation?

The clinical trial endpoints were arrhythmia free at 12 months after a 90-day blanking period.

The benefits associated with PFA over current ablation modalities include tissue selectivity and reduced procedure times.

How do the outcomes compare to current ablation modalities?

The data look promising with recent study results suggesting nearly 80% of patients were free from atrial arrhythmias at one year. Data also shows high procedural success (99%), with major adverse events at 1.9%.

What is the learning curve for usage / how many procedures need to be performed to have developed proficiency where we would begin seeing shortened procedure times?

Anticipate physicians becoming comfortable with new technology after 5-10 clinical cases.
 

Ready to learn more?

Connect with a Vizient subject matter expert to evaluate strategic considerations such as clinical trial data, capital investments and financial implications of this evolution in cardiac care.