FORT MILL, S.C., Nov. 02, 2026 (GLOBE NEWSWIRE) -- Catheter Precision, a wholly owned subsidiary of Flyte Aviation, Inc. (NYSE American: VJET), today announced that its VIVO system has received FDA 510(k) clearance for expanded labeling in its Indications for Use statement.
The VIVO system is now cleared for a broader patient population, specifically individuals with structural heart disease (SHD) who are undergoing catheter ablation for monomorphic ventricular tachycardia (VT).
Structural Heart Disease (SHD) involves damaged, scarred, or enlarged heart tissue that disrupts the heart's natural electrical pathways. This structural damage frequently triggers severe arrhythmias, such as Ventricular Tachycardia (VT). While standard care relies heavily on implantable defibrillators and medications, catheter ablation remains underutilized due to long procedural times and inconsistent outcomes.
"This expanded U.S. labeling for VIVO is another milestone in delivering enhanced ablation strategies," said David Jenkins, CEO of Catheter Precision. "Our clinical data demonstrates that VIVO maintains the same high standards of accuracy and safety in patients with structural heart disease as it does in those without it. Ventricular ablations are inherently complex, but SHD cases present unique challenges because every patient's anatomy is different. By enabling physicians to visualize a patient's specific anatomy ahead of time, VIVO improves pre-procedural planning, which can reduce overall procedure times and optimize patient outcomes."
About VIVO
Catheter Precision's VIVO™ (View Into Ventricular Onset) is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias prior to an electrophysiology procedure, potentially streamlining procedural workflow. VIVO has received marketing clearance from the U.S. FDA and carries the CE Mark.
About Catheter Precision
Catheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.
About Flyte Aviation, Inc.
Flyte Aviation, Inc. is a holding company for Fly Flyte and Ponderosa Air. Fly Flyte is a technology-enabled private aviation company operating a growing fleet of Cirrus Vision Jets and providing efficient private air travel throughout the United States and select international markets. Through its direct-to-consumer booking platform, standardized pricing on select routes, strategic partnerships, and FAA-certified Part 135 operating subsidiary, Ponderosa Air, LLC, Flyte is delivering a faster, safer and more convenient private aviation experience.
For more information, visit www.flyflyte.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements regarding expected future growth, demand, strategic partnerships, market expansion, brand awareness, aircraft utilization and Flyte’s future operations, are forward-looking statements and involve risks and uncertainties that could cause actual results to differ materially. Readers are encouraged to review the Company’s filings with the Securities and Exchange Commission, including its Forms 10-K and 10-Q, for a discussion of these risks.
Contact
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(800) 763-0904
