Keystone Heart

About Keystone Heart

Keystone Heart specializes in developing advanced cerebral embolic protection devices designed to reduce brain injury during transcatheter aortic valve replacement (TAVR) procedures. The company's flagship product, the TriGuard Cerebral Embolic Protection Device, is engineered to protect all three major arteries in the brain, thereby minimizing the risk of stroke and other brain injuries during cardiovascular interventions. Keystone Heart primarily serves healthcare providers and medical institutions involved in cardiovascular procedures, focusing on markets both within and outside the United States. The business model revolves around the development, clinical testing, and eventual commercialization of its medical devices. Revenue is generated through the sale of these devices to hospitals and clinics, as well as through partnerships and licensing agreements. Currently, the TriGuard device is CE marked and approved for investigational use in the US, pending FDA clearance.