Medical diagnostics

Keeping a pulse on the EP market

Experts predict an evolution in electrophysiology as new technologies in pulsed field ablation hit the market.

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). 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 are helping healthcare providers gain insight into how these changes may impact care pathways for cardiac patients, sharing best practices when adopting the new technology and exploring 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.

Pulsed field ablation and electrophysiology resources​

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

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When will pulsed field ablation be available?

Most suppliers have participated or are participating in clinical trials. One system gained FDA approval in December 2023: the Medtronic PulseSelect System. Boston Scientific gained FDA approval for FARAPULSE™ in January 2024. Additional supplier commercialization targets are anticipated in 2025.

How can I best prepare for this new technology to ensure readiness as it becomes more broadly 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.