Mission Hospital Completes First-in-Human Trial of EmStop Stroke Prevention Device for Heart Valve Surgery
Key Insights
Mission Hospital successfully completed the first-in-human phase of a clinical trial testing the EmStop (search) device, an innovative stroke (search) protection system designed to prevent debris-related strokes during transcatheter aortic valve (search) 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.
Mission Hospital in western North Carolina has successfully completed the first-in-human clinical trial of EmStop (search), a novel stroke (search) prevention device designed to enhance safety during transcatheter aortic valve (search) replacement (TAVR) procedures. The innovative device, developed by local cardiac surgeon Mark Groh, aims to address the persistent risk of stroke caused by dislodged debris during heart valve replacement surgery.
Breakthrough Results Lead to Expanded Trial
The initial phase of the clinical trial demonstrated promising results across all ten patients treated at Mission Hospital, with no strokes reported in any of the procedures. Dr. Michael Chenier, Structural Heart Interventional Cardiologist at Mission Hospital and Principal Investigator on the study, emphasized the significance of these outcomes: "The data was so positive and so favorable that the FDA then approved the next phase of the study called the Capture II study and so that's what we call a pivotal trial."
James Balcerek, who experienced breathing difficulties and fatigue due to aortic valve (search) stenosis, became the first patient worldwide to receive the EmStop (search) device during his TAVR procedure. "For going to the hospital it was a good experience," Balcerek said, reflecting on his successful treatment outcome.
Addressing Critical Safety Concerns in TAVR Procedures
TAVR has emerged as a life-saving alternative to open-heart surgery for patients with severe aortic stenosis (search), particularly those at high surgical risk. However, the procedure carries inherent stroke (search) risks when calcium buildup around the valve is dislodged during the intervention. According to Dr. Chenier, "That risk, thankfully, is low. For a major stroke is about 1.5%. But for any kind of stroke, that risk is about 4 to 5% for patients."
The EmStop (search) device functions as a protective filter, covering the back end of the catheter to catch any calcium debris released during the valve replacement process. This mechanism directly targets the root cause of procedure-related strokes, potentially making TAVR procedures significantly safer for patients.
National Expansion and Future Implementation
The FDA's approval of the Capture II pivotal study represents a major milestone for the EmStop (search) technology. The expanded trial will involve up to 25 centers throughout the United States, "stretching all the way from California, to the northeast, to the southeast," according to Dr. Chenier. This multi-center approach is expected to include more than 1,000 patients, providing robust data on the device's safety and efficacy across diverse patient populations.
The successful completion of the initial trial positions the EmStop (search) device as a potential standard component of valve replacement procedures in the future. Mission Hospital's role in this groundbreaking research reflects its commitment to advancing cardiovascular care, with more than 35 active clinical trials under the HCA Healthcare Research Institute (search), including 25 focused on cardiac subspecialties.
Clinical Impact and Procedural Innovation
The TAVR procedure itself represents a significant advancement in cardiac care, allowing physicians to replace aortic valves through a minimally invasive approach. "When we do that, we typically go from the leg artery," Dr. Chenier explained. "We do not have to do open-heart surgery for that. We advance the valve up to the heart and implant it through a catheter."
The integration of the EmStop (search) device into this already innovative procedure could further reduce complications and improve patient outcomes. Dr. Chenier noted the clinical significance: "The clinical data was very promising. We were very excited."
As the Capture II study moves forward, the medical community will closely monitor results to determine whether this locally-developed innovation can become a standard of care for TAVR procedures nationwide, potentially benefiting thousands of patients who require aortic valve (search) replacement surgery.