Abiomed and a clutch of other developers of cardiovascular disease devices have received breakthrough designations from FDA, setting them up to benefit from regulatory perks as they try to bring their products to market.
FDA awarded the breakthrough privileges to Abiomed's Impella ECP expandable percutaneous heart pump. Abiomed is pitching the experimental device as the world's smallest heart pump and the first that is suitable for use with small bore access and closure techniques. By developing a pump that is smaller than its existing Impella products, Abiomed is aiming to enable more coronary artery disease patients to receive hemodynamic support.
Earlier this month, Abiomed CEO Mike Minogue told investors an early feasibility study of the device is running ahead of schedule. Abiomed has enrolled 25 patients and submitted data for review ahead of the planned expansion of the study. The progress led one analyst to speculate about whether the device could win approval around the end of 2023.
Hancock Jaffe Laboratories received FDA breakthrough status for its potential treatment for chronic venous insufficiency. The VenoValve device is a prosthetic valve that is designed to mitigate the failure of the venous valves that enable blood to return to the heart from the lower limbs. Hancock shared first-in-human data on the device last year and is now preparing to move into a pivotal clinical trial.
FDA awarded a breakthrough designation to Neuralert Technologies' medical device for hospital stroke detection. The University of Pennsylvania spinout is developing the Neuralert Monitor in the belief that the current manual approach to detection means only a fraction of in-hospital strokes are identified in a timely manner. Neuralert's product is designed to accelerate stroke detection through the use of wearable devices that detect the onset of asymmetric movement.
Helius Medical Technologies received breakthrough status for a device targeted at patients who are suffering dynamic gait and balance deficits because of symptoms from stroke. The Portable Neuromodulation Stimulator delivers electrical stimulation to treat gait deficit, and is already indicated for use in patients with mild-to-moderate symptoms from multiple sclerosis.
CytoSorbents is the other recent recipient of a breakthrough device designation for a cardiovascular disease product. The breakthrough status covers a technology for removing the direct oral anticoagulants apixaban and rivaroxaban in a cardiopulmonary bypass circuit. Removing the drugs could "reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery," according to CytoSorbents.
In other disease areas, Altoida received breakthrough designation for a non-invasive software device that predicts if a person with mild cognitive impairment will develop Alzheimer's disease in the next 12 months. The artificial intelligence prediction is based on the patient's performance on "a 10 minute set of augmented reality and motor activities on their smartphone or tablet."
Finally, FDA granted breakthrough device status to Swing Therapeutics' digital therapeutic for the management of fibromyalgia. The device delivers a form of cognitive behavioral therapy that could improve the function and symptoms of fibromyalgia patients.