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- UNC Health has submitted a Certificate of Need application to North Carolina DHHS for a 92-bed hospital near downtown Asheville, with a hearing scheduled for August and a final decision expected in December. - The proposed Asheville facility would offer emergency care, intensive care, neonatology, cardiology, gastroenterology, radiology, psychiatry, and other specialty services on a 21.5-acre site near Westgate Mall. - UNC Health also unveiled plans for a new community hospital in Wilmington on a 62-acre site at South 17th Street and Shipyard Boulevard, targeting a 2030 opening date pending regulatory approvals. - Both proposals aim to address growing regional demand and provide more healthcare choice, with UNC Health CEO Dr. Cristy Page emphasizing the goal of delivering "care closer to home."
- Mission Hospital successfully completed the first-in-human phase of a clinical trial testing the EmStop device, an innovative stroke protection system designed to prevent debris-related strokes during transcatheter aortic valve replacement procedures. - All ten patients in the initial trial, including the first patient James Balcerek, underwent successful procedures without experiencing strokes, prompting FDA approval for the next phase of testing. - The FDA has approved the Capture II pivotal study, which will expand to 25 centers across the United States and include over 1,000 patients to further evaluate the device's safety and efficacy. - The EmStop device addresses a significant clinical need, as stroke risk during TAVR procedures affects 4-5% of patients overall, with major strokes occurring in approximately 1.5% of cases.
