V-Wave's Journey to FDA Approval: A Case Study in Navigating the Breakthrough Devices Program

The acquisition of V-Wave by Johnson & Johnson is a noteworthy milestone in the medical device industry. At the heart of this success story is not only V-Wave’s innovative interatrial shunt, which addresses critical needs in heart failure treatment but also the company’s strategic use of the FDA’s Breakthrough Devices Program—a regulatory pathway that played a pivotal role in accelerating the device’s journey to market.

Understanding the FDA Breakthrough Devices Program

The FDA’s Breakthrough Devices Program was launched under the 21st Century Cures Act in December 2016. The program’s primary goal is to expedite the development and review of medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. This expedited process is designed to ensure that patients and healthcare providers have quicker access to innovative technologies while maintaining the FDA’s high standards for safety and efficacy.

Eligibility Criteria and Program Impact

To qualify for the Breakthrough Devices Program, a device must:

1. Provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions; and
2. Meet at least one of the following criteria: Represent Breakthrough Technology; Offer significant advantages over existing alternatives; Address a condition with no approved alternatives; Be in the best interest of patients.

Since its inception, the program has granted designation to over 700 devices, though only those showing significant clinical benefits are likely to achieve @FDA approval. The program’s impact has grown substantially since 2018, with a marked increase in the number of designations, particularly in the cardiovascular and neurology fields—areas where V-Wave’s technology plays a significant role.

Figure 1: Number of Granted Breakthrough Device Designations by Year

Data includes devices that were designated under the precursor Expedited Access Pathway (EAP). Since the vision and designation criteria between the precursor EAP Program and the Breakthrough Devices Program are consistent, the FDA considers devices granted designation under the EAP to be a part of the Breakthrough Devices Program.

*Indicates the 2024 data are from October 1, 2023, through December 31, 2023.

Source: FDA

As the graph shows, the number of Breakthrough Device designations has increased significantly since 2018, highlighting the growing recognition and utilization of this program. This increase reflects the industry's response to the program's value in accelerating the development of cutting-edge technologies.

Graph 2: Number of Granted Breakthrough Device Designations by Clinical Panel

Source: FDA

This graph illustrates the diversity of clinical areas benefiting from the Breakthrough Devices Program, with Cardiovascular and Neurology leading the way. V-Wave’s interatrial shunt, which falls within the cardiovascular category, is a prime example of the type of innovation that the program aims to support.

Strategic Advantages for V-Wave

V-Wave’s decision to pursue the Breakthrough Devices Program was strategic. By securing multiple Breakthrough Device designations, V-Wave was able to benefit from:

• Accelerated Review Process: The FDA’s priority review significantly reduced the time required for market approval.
• Enhanced Communication: Regular, detailed interactions with the FDA helped V-Wave address regulatory issues early and streamline the approval process.? This process enabled V-Wave to work with the FDA to establish what they would need to prove to get approval.
• Flexible Clinical Study Designs: The program allowed V-Wave to tailor its clinical trials to better align with both the device’s innovation and patient needs.

These strategic advantages not only facilitated the device’s approval but also made V-Wave an attractive acquisition target for Johnson & Johnson.

Lessons for the Medical Device Industry

The FDA’s Breakthrough Devices Program serves as a powerful tool for companies developing innovative medical devices. However, successful navigation of this program requires a deep understanding of regulatory pathways and how to translate this into their Quality System, a robust clinical strategy, and the resources to engage effectively with the FDA. V-Wave’s journey through the program offers a valuable case study for other companies looking to bring groundbreaking technologies to the market.

For a more in-depth exploration of the FDA’s Breakthrough Devices Program and V-Wave’s strategic journey, you can read the full article on our website.

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