The FDA's Breakthrough Devices Program is experiencing a resurgence, marked by a significant increase in designations and approvals. In the most recent financial year, the program designated 166 products, reversing a downward trend observed after the peak of the COVID-19 pandemic. This initiative aims to expedite the development and review of medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Program Growth and Impact
The Breakthrough Devices Program facilitates increased interaction between device developers and FDA experts during the premarket review phase, allowing for timely resolution of issues and prioritized review. After an initial climb, with designations reaching 206 in 2021, numbers fell to 166 in 2022 and 145 in 2023. However, early data from 2024 indicated a turnaround, with 58 products designated in the first three months, compared to 32 in the same period of 2023. Cardiovascular, neurology, and orthopedic devices have been prominent among the recent designations.
As of September 30, the FDA has authorized a total of 128 breakthrough devices for the U.S. market, with 33 approvals granted in the final nine months of the financial year. Among the recent authorizations are devices from Pi-Cardia, Renata Medical, and Neuros Medical, each addressing critical unmet needs in their respective fields.
Featured Breakthrough Devices
Pi-Cardia's Shortcut TAVR Device: Pi-Cardia's Shortcut transcatheter aortic valve replacement (TAVR) device received de novo authorization in September. This device is designed to reduce the risk of coronary obstruction during valve-in-valve TAVR procedures, which are performed to address failing TAVR devices without resorting to open-heart surgery. The Shortcut device mitigates this risk by splitting aortic valve leaflets prior to valve placement, preventing obstruction caused by the leaflets of the failing valve.
Renata Medical's Minima Growth Stent: Renata Medical's Minima Growth Stent received premarket approval in August. This device is designed for use in neonates, infants, and young children with narrowed vessels in the aorta or pulmonary arteries, a condition that can lead to heart failure and death if left untreated. The Minima stent can be crimped down to 2mm for insertion through small vessels and expanded using a balloon catheter, allowing physicians to adapt the stent to the child's growth.
Neuros Medical's Altius System: Neuros Medical's Altius system, a direct electrical nerve stimulation system, also received premarket approval in August. It is intended for the management of phantom and residual lower limb pain in adult amputees, a common issue resulting from damaged nerve endings. The Altius system stimulates these damaged nerves to block pain signals from reaching the brain. Clinical trial data supporting the approval showed that patients receiving active Altius treatment were three times more likely to experience significant pain relief compared to those receiving a sham-control treatment.
