New temporary pacing system for TAVR launches in US
A new temporary pacing system designed to improve safety and efficiency during transcatheter aortic valve replacement (TAVR) procedures that recently gained U.S. Food and Drug Administration clearance was commercially launched this week.
The SoloPace Fusion Temporary Pacing System from Solo Pace Inc. is designed to eliminate the need for right ventricular (RV) lead placement, which requires the added procedural step to gaining venous access. This can cut procedure time and mitigate possible complication risks. For interventional cardiologists using improvised left ventricular (LV) pacing, this system can replace ad-hoc clip assemblies, subcutaneous needles and exposed wire connections, which are known sources of inconsistent pace capture that leads to workflow variability.
"In our initial experience with SoloPace Fusion, we've been able to shift from conventional RV pacing during many of our TAVR procedures. RV pacing introduces risks for our patients, such as perforations and venous access issues, not to mention the time it adds to procedures. Never before have we had the combination of reliable LV pacing combined with smooth tracking and stability for valve deployment in one guidewire," explained Stanley J. Chetcuti, MD, director of the cardiac cath lab at University of Michigan Health, in a statement.
The company said the single use device comes in a sterile kit and offers guidewire functionality, LV pacing and patient grounding in one device to deliver a standardized, predictable pacing method intended to simplify setup and reduce variability. SoloPace Fusion is used with the existing SoloPace Control external pulse generator (EPG). The system also offers automated pace capture checks and simple visual indicators.
"Clearance of our SoloPace FUSION System is a major milestone for our company and reflects our continued commitment to developing effective and efficient solutions for the growing number of Transcatheter Aortic Valve Replacement (TAVR) procedures done each year in the United States," said Solo Pace CEO, David Daniels, MD. "Our unique LV temporary pacing solution eliminates the need for improvised workarounds without compromising necessary guidewire performance. It will not only drive greater cath lab efficiency, but has the potential to deliver safer TAVR procedures for patients."
Merit Medical is the exclusive distributor of the SoloPace Fusion system in the United States.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]