The FDA has recently granted breakthrough device designations to several innovative medical devices, signaling potential advancements in the treatment of Alzheimer's disease, cardiovascular conditions, and other critical illnesses. These designations aim to expedite the development and review process for devices that offer potentially more effective treatment options for life-threatening or irreversibly debilitating conditions.
Alzheimer's Disease
Functional Neuromodulation, in partnership with Boston Scientific, is studying Vercise DBS systems for Alzheimer's. The FDA awarded breakthrough status to Boston Scientific's Vercise deep brain stimulation (DBS) systems in people aged 65 years and older with mild probable Alzheimer's. Boston Scientific already sells Vercise in the U.S. as a treatment for motor symptoms associated with Parkinson's disease. Functional Neuromodulation has been gathering data for years, with a pivotal study involving 210 subjects expected to be completed in October 2023. The breakthrough status promises closer interaction with the FDA and a faster review process.
Cognito Therapeutics also received breakthrough designation for its non-invasive neurostimulation device. This device aims to stimulate the brain at a specific frequency, potentially reactivating the brain's immune system. Clinical trials have shown that Alzheimer's patients in the treatment arm exhibited improved cognitive and functional outcomes compared to placebo. Tom Megerian, chief medical officer at Cognito, noted this designation recognizes the strength of the clinical evidence supporting their lead product.
Cardiovascular Innovations
Several cardiovascular devices have also received breakthrough status. Puzzle Medical Devices secured the designation for its ModulHeart, a minimally invasive transcatheter heart pump designed for heart failure patients. This pump offers a less invasive alternative to open-heart surgery, implanted in the descending aorta via the subclavian artery.
Alleviant Medical received breakthrough status for its implant-free approach to treating chronic heart failure. Their transcatheter technology decompresses the left atrium without requiring a permanent implant or open-heart surgery. Data from initial procedures is expected later this year.
Vascular Perfusion Solutions (VPS) gained breakthrough designation for its cardiac transport device, designed to preserve vascularized tissue for eight hours using oxygenated perfusion. This device, fitting in an airliner's overhead compartment, aims to increase the number of successful heart transplants by extending the time hearts can be preserved outside the body.
Berlin Heals announced that its Cardiac Microcurrent Therapy System received the FDA’s breakthrough device designation. The implantable solution was designed to target heart failure by delivering a “constant, but minimal” DC current to the heart through two electrodes. Preclinical trials also found that the system also had a “strong anti-inflammatory effect” and improved cardiac function, the company said.
Other Notable Designations
Roche received breakthrough status for its Elecsys growth differentiation factor-15 (GDF-15) assay. This assay helps identify cancer patients suitable for innovative treatments addressing unintentional weight loss, specifically those with GDF-15 levels of 1.5 ng/mL or greater, correlating with cachexia and reduced survival.
ShiraTronics received breakthrough status for its neurostimulation treatment for chronic migraine. Geistlich Pharma received breakthrough status for its Chondro-Gide articular cartilage cover, a collagen membrane designed for use in a single-step cartilage repair technique.
These breakthrough designations highlight the FDA's commitment to accelerating the development and availability of innovative medical devices that address significant unmet medical needs across a range of conditions.
