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.

12M

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

Vizient has great expertise, from both a clinical and a supply chain lens, and is well versed in the creation of opportunities in the face of obstacles. They also dive in deep to assess both clinical and financial implications of new and potentially disruptive technologies coming to market such as pulsed field ablation for atrial fibrillation.
Rob Lerman, MD VP, Category Management - Cardiovascular Vizient, Inc.

FAQs

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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.
Speak with physician providers about their desire to bring this technology into the practice, anticipated timelines, budget constraints, and purchasing strategies
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.
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.
There are no expected changes to reimbursement.
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).
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.
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%.
 

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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.