Lead Inventor of UltraNav System Presents New Double Lumen Catheter at TCT 2023

October 25, 2023 — Information on a new double lumen catheter was presented by Nabil Dib, MD, MSc, FACC, FESC, during the 2023 Transcatheter Cardiovascular Therapeutics conference, TCT 2023, being held Oct. 23-26 in San Francisco, CA. The novel platform for structural heart interventions is now in human use, with ability to improve patient recovery and reduce anesthesia and hospital stays, according to a statement on the session. “A Double Lumen Catheter to Facilitate Atrial Septal Procedure and the Transseptal Delivery of Catheters: Dib UltraNav Transseptal Catheter System/Catheter-Based Treatment of Congenital Heart Disease: ASD, PFO, and RVOT Obstruction II,” was presented as a Moderated Abstract: Emerging Clinical Science & Research today during the annual Cardiovascular Research Foundation (CRF) TCT conference. A summary of that session, prepared for DAIC, follows.

The Dib UltraNav Transseptal Catheter System, which houses a needle and ultrasound in one system for use in atrial transseptal procedures and delivery of catheters, has now been successfully used in 15 human cases, at major cardiology hospitals in Arizona and Minnesota. The system facilitates atrial septal procedures and the transseptal delivery of catheters. In doing so, reports Dib, the new device enables safer and more cost-effective transseptal procedures by aligning catheter and ultrasound.

Dib is an interventional cardiologist, and also an inventor and member of Dib UltraNav Medical, the company marketing the new Dib UltraNav Transseptal Catheter System, for which he was the lead inventor. He is founder and president of the International Society for Cardiovascular Translational Research (ISCTR); founder and editor-in-chief of the Journal of Cardiovascular Translational Research; and the director of clinical and translational cardiovascular research at Dignity Health.

During the moderated abstract session, Dib offered the following:

UltraNav improves the safety and accuracy of transseptal procedures by enabling better visualization of the catheter, needle, and needle tip. It facilitates safer and more predictable transport of intracardiac echocardiography (ICE) and other catheters/wires from the right into the left atrium of the heart. Its use also suggests it may reduce the need for Transesophageal Echo (TEE) interventions.

As such, UltraNav replaces the current procedural approach of using a separate needle and ultrasound beam on two different planes, which provides only a partial image of the orientation and depth of the needle and its tip, further disrupted by the cardiac and respiratory motion of the patient. Because UltraNav is a single system that aligns the catheter/needle with the ultrasound beam on the same plane, it provides more precise, continuous, and complete visualization for the clinician. Improved visualization reduces complications and increases catheter alignment during transseptal procedures.

“There’s been a significant rise in structural transseptal heart procedures, which mandates the need for a safer, more accurate approach,” said Dib, founder of Dib UltraNav Medical. He added, “Although the current risks may be low, complications can be fatal. Reducing serious complications such as heart perforation and reducing the need for anesthesia with a novel one-catheter system will change the way we approach structural heart interventions, reduce the learning curve for physicians, and expand the treatment to more patients.”

The single-use, dual-lumen, non-steerable Dib UltraNav System intravascular catheter and handle received FDA 510(k) clearance in March 2022. It is compatible with frequently used needles, RF wires, and various ICE catheters. It has a broad indication for use for puncture of the septum and transport of ICE catheters to the left atrium and is applicable for any septal or left heart procedures, including appendage closure procedures, valve interventions, and catheter-based ablation. Starting in April 2023, UltraNav has been used in 16 human procedures at major cardiology centers in Minnesota and Arizona.

Addressing the significant increase in transseptal procedures, Dib reported that transseptal procedures have evolved since the late 1950s when, in 1959, hemodynamic assessments began. By 1984, percutaneous balloon mitral valuloplasty (PBNMV) procedures were being used, followed by pulmonary vein isolation (PVI) in the 1990s, and left atrial appendage occlusion (LAAO) and percutaneous left ventricular assist devices (pLVAD) by 2003. In 2006, mitral paravalvular leak (PVL) repairs were being conducted and, by 2008, transcatheter mitral valve repairs (TMVr) were introduced. Four years later, mitral valve in valve (VinV) implantations were performed, as were transcatheter mitral valve replacements (TMVR).

In 2021, 375,000 transseptal left heart procedures were conducted, of which approximately 250,000 were AF ablations. Today’s transseptal procedures include LAA closure, mitral valvuloplasty, MitraClip, TMVR, PFO closure, PVL repair, septostomy, antegrade TAVR, and electrophysiology. In 2025, it is estimated that approximately 900,000 transseptal heart procedures will be performed, a 140% increase from 2021.

The statistics add up to represent a large and growing market for septal procedures. He continued, identifying an increased need to enhance safety and performance in transseptal procedures, noting: While the percentage of septal procedures with complications is low, the overall increase in septal procedures will likely lead to an increase in the number of complications, and consequences can be catastrophic. Today, 4.3% of transseptal procedures, most involving TEE interventions, result in unintentional perforations, added Dib.

UltraNav was designed to reduce these complications, while enhancing patient experience and convenience and reducing costs related to these procedures.

In detailing the workings of the UltraNav system, the written statement offered the following: Current transseptal procedures require either the placement of an ICE catheter into the heart or a transesophageal echo (TEE) imaging catheter into the esophagus to display ultrasound images that guide the transseptal puncture needle and treatment catheter. The ICE catheter procedure involves the use of two systems -- a needle and an ultrasound beam, functioning on two different planes – which provides only a partial and intermittent, and thus less than adequate, image of the orientation of the catheter and needle, needle length, and depth of the needle tip relative to the cardiac structure. The TEE procedure requires general anesthesia.

The UltraNav catheter, the report continued, combines the needle and ultrasound into one system, where they function together on the same plane. One system vs. two also reduces visual disruptions from the cardiac and respiratory motion of the patient during the procedure. General anesthesia is not required when UltraNav is used.

UltraNav’s side-by-side, simultaneous intracardiac echocardiography (ICE) and working lumen enter the right atrium, and cross and see into the left atrium. The system also facilitates delivery of ICE catheters and other catheters/wires from the right to left atrium with ease, reducing the need for TEE. The statement on the presentation further noted that the UltraNav system is compatible with current needles, VersaCross RF wires, and various types of ICE catheters. As such, it reported the result is more precise and continuous visualization during transseptal procedures. With one system, cardiologists can provide a more precise puncture of the septum and see exactly where they are in the procedure, with a complete picture of the heart’s internal anatomy and the catheters and needles being used. This improves performance, reduces complications, and contributes to the success of the procedure.

Franklin Mountain Medical, a subsidiary of Franklin Mountain Capital, is the Lead investor in UltraNav.

For more information: www.franklinmountaincapital.com 

For more of DAIC’s TCT23 conference news coverage here