Boston Scientific Halts Sales of Heart Device in EU & Foregoes Approval in Other Markets Due to Regulatory Hurdles

Key Takeaways

• Discontinuation of Sales: Boston Scientific has ceased sales of its Acurate Prime and Acurate neo2 heart devices in the EU and will not seek approval in other markets due to increased regulatory requirements.
• Clinical Setbacks: A recent clinical study revealed that the Acurate neo2 failed to meet its non-inferiority goal compared to other TAVR devices, leading to declining sales in the EU.
• Regulatory Challenges: Discussions with U.S. and global regulators resulted in heightened approval requirements, including a new randomized clinical trial, registries, and extensive post-market surveillance.
• Financial Impact: Despite the anticipated financial hit, Boston Scientific expects to meet its second-quarter and full-year sales and adjusted profit forecasts.

Deep Dive

Boston Scientific has decided to discontinue sales of its Acurate Prime and Acurate neo2 heart devices in the European Union, a move that will also see the company forgo seeking approval in the U.S. and other international markets. The decision, announced on Wednesday, stems from escalating clinical and regulatory hurdles that the company has deemed too resource-intensive to meet, first reported by Reuters.

The Acurate devices, which had previously secured the EU's CE-mark, were designed to help restore blood flow in patients with severe aortic stenosis—a condition where the heart’s aortic valve becomes narrowed or blocked. These devices had been a part of the company’s effort to innovate in the area of transcatheter aortic valve replacement (TAVR), but recent developments have led to the difficult decision to halt their sales.

What triggered this shift? A clinical study last year revealed that the Acurate neo2 failed to meet its non-inferiority goal when compared to other TAVR devices. Analysts were quick to point out that the resulting decline in sales across the EU was a reflection of the device’s performance in the market. Citi analyst Joanne Wuensch summed it up in a client note, calling the move “wise” given the challenges ahead, particularly when it comes to managing the company's resources effectively.

But the clinical setbacks alone weren't the only factor. In conversations with regulators in the U.S. and elsewhere, Boston Scientific found that the requirements for approval had become much more stringent. These new demands included the need for an entirely new randomized clinical trial, the creation of extensive registries, and rigorous post-market surveillance activities. A company spokesperson, in conversation with Reuters, acknowledged that these added requirements would require a significant investment of time and capital, which the company deemed "prohibitive."

Despite the financial hit expected from this decision, Boston Scientific has reassured investors that it still anticipates meeting its sales and adjusted profit forecasts for the second quarter and the rest of the year. The company continues to focus on its core growth areas, such as its stroke prevention device, Watchman, and the Farapulse system, which treats certain abnormal heart rhythms with short bursts of high-voltage pulses.

In a world where medical device companies are constantly navigating an evolving regulatory landscape, Boston Scientific's decision highlights the delicate balance between innovation, clinical outcomes, and the regulatory realities that drive market access. For now, the focus will be on its other leading products, ensuring that the heart device setback doesn't overshadow the promising potential of its other offerings.

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