David Rizik, MD, is an interventional cardiologist at Banner University Health.

David Rizik, MD

Balancing Enthusiasm With the Need for Trial Data, With David Rizik, MD, and Michael Morris, MD

 from Banner Health gave a live demonstration of the Heartflow PCI Navigator, an investigational, AI-driven device that analyzes CT scan data to generate 3D models of patients’ venous systems to help clinicians determine optimal stent placement.

First debuted at the Transcatheter Cardiovascular Therapeutics (TCT) conference from October 25-28, 2025, the Navigator more specifically generates models of the patient’s anatomy, plaque composition, and lesion-specific physiology, giving clinicians access to all necessary data before entering the catheterization lab for stenting procedures. The current presentation, delivered at the inaugural Scottsdale Interventional Forum (SCI) in Phoenix, Arizona, was many clinicians’ first example of the technology.

However, despite the promise of this new technology, it is still very much in the investigative phase. The first in-human trials of the Heartflow PCI Navigator have yet to take place. To discuss the dichotomy between enthusiasm for new technology and the necessary steps to clear it for clinical use, as well as how clinicians can balance this frustrating reality, the 

 editorial team spoke with David Rizik, MD, an interventional cardiologist at Banner University Health and co-leader of the session, and Michael Morris, MD, a diagnostic radiologist at Banner University Health and the other session co-leader.

“The frustrating thing is that we always want to have the outcomes data at the same time as we get the new information, but there’s a delay,” Morris told 

. “Right now, we’re at the early aspect of the process, where we just now have it available, and we have thought leaders who are enlightening us as to how best these tools can be used in terms of enhancing the clinical pathway.”

The Heartflow PCI Navigator was developed as a result of the PLAN CALCIUM study, a retrospective cohort analysis which was presented alongside the Navigator at TCT 2025. A total of 85,306 patients were included in the analysis, of whom 4936 were receiving CCTA and 80,370 were not.

Investigators established a composite endpoint of all-cause mortality, heart failure, and AMI at 1 and 5 years of follow-up; by the end of the trial, 9.6% of patients receiving CCTA exhibited this endpoint versus 13% of those not receiving CCTA at 1 year. Additionally, at the 5-year mark, 16.1% of recipients and 23.7% of non-recipients exhibited the composite endpoint.

Heartflow has also announced that it is actively recruiting patients into the NAVIGATE-PCI registry, which will assess the Navigator’s effect on procedural safety and efficacy, strategy and patient outcomes, and physician confidence compared to standard treatments. The registry aims to enroll >2500 patients; currently, it is targeting roughly 30 sites across the US.

Until this study – and its subsequent clinical trials – are complete, clinicians remain limited to traditional stent treatment. Rizik and Morris acknowledge that this is a point of frustration, given the hypothetically superior outcomes that the Heartflow PCI Navigator can provide for patients. However, they urge patience, as the actual practical efficacy – and potential limitations – of the technology are still unknown.

“A very wise cardiologist once said, no matter how enthusiastic you are, you put your prejudices aside, and you do the studies,” Rizik told 

Editor’s Note: Rizik reports disclosures with Abbott Vascular, Biotronik, Cordis, Trireme, and Boston Scientific. Morris reports no relevant disclosures.

Banner Health. Banner Health pioneers advanced treatment for complex coronary disease. February 11, 2026. Accessed February 12, 2026. 

https://www.bannerhealth.com/newsroom/press-releases/complex-coronary-disease

Patel A, Sandoval Y, Mullen S, et al. TCT-417 coronary CT angiography and AI-enabled coronary plaque analysis to inform PCI and lesion preparation: The plan calcium study. JACC. 2025;86(17). 

Heartflow. New Heartflow PCI Navigator to Equip Interventional Cardiologists with Pre-procedural Insights to Enable PCI Planning. October 22, 2025. Accessed February 12, 2026. 

https://ir.heartflow.com/news-releases/news-release-details/new-heartflow-pci-navigator-equip-interventional-cardiologists

Videos

Rizik and Morris discuss the Heartflow PCI Navigator and its promising implications for patients – and how they manage that excitement while waiting for trial data.

Balancing Enthusiasm for New Technologies With the Need for Trial Data, With David Rizik, MD, and Michael Morris, MD

Banner Health Debuts AI 3D Vascular Modeling Device, With David Rizik, MD, and Michael Morris, MD

At the inaugural Scottsdale Interventional Forum (SCI) in Phoenix, Arizona, on February 11, 2026, 

 from Banner Health presented a live demonstration of the Heartflow PCI Navigator, an AI-driven technology designed to analyze CT scan data and generate patient-specific 3D models to optimize stent placement.

The Heartflow PCI Navigator was first debuted at the Transcatheter Cardiovascular Therapeutics (TCT) conference, which ran from October 25-28, 2025, in San Francisco, California. Prior to stenting procedures, patients may undergo a CT scan in addition to a diagnostic angiogram. The CT data is then fed into an AI-driven technology, which creates 3D models of the patient’s anatomy, plaque composition, and lesion-specific physiology. This allows clinicians to effectively plan out procedures with all relevant data before patients enter the catheterization lab.

“For physicians, for interventional cardiologists, and for those who do heart and vascular procedures, this is a peek into the future,” David Rizik, MD, an interventional cardiologist at Banner University Health and co-leader of the session, told 

 in an exclusive interview. “It’s amazing that we are now developing a tool that gives us AI-generated guidance for treating blocked coronary arteries, and we receive that guidance before we ever start the procedure to open a blocked artery.”

In addition to the Heartflow PCI Navigator, Banner Health incorporated an intravascular lithotripsy device, which delivers controlled shockwaves into blood vessel walls. This, in turn, breaks down calcium deposits before stent placement initiation. The device functions similarly to treatments for kidney stones, utilizing sound waves to break up hardened calcium and make previously untreatable vessels accessible.

Although the device is still very much in the preliminary stages of testing, Heartflow is actively recruiting patients to the NAVIGATE-PCI Registry, which aims to include >2500 patients across roughly 30 sites in the US. The registry will assess the PCI Navigator’s effect on physician confidence, procedural safety and efficacy, and strategy and patient outcomes compared to standard care.

Additionally, the PLAN CALCIUM study, a retrospective cohort analysis presented at TCT 2025, showed that patients receiving CCTA within a year prior to PCI saw lower rates of a composite endpoint of all-cause mortality, heart failure, and AMI at 1 and 5 years follow-up. The trial enrolled 4936 patients receiving CCTA and 80,370 without. Of these, 9.6% of CCTA recipients exhibited the composite endpoint versus 13% of those not receiving CCTA at 1 year, and 16.1% of recipients versus 23.7% non-recipients exhibited the composite endpoint at 5 years (HR, 0.74; 95% CI, 0.66-0.83).

“A tool like this can potentially elevate all users to operate at a very high level, giving them access to the same sort of thought process and experience that an expert user has, elevating access to expertise for all patients,” Michael Morris, MD, a diagnostic radiologist at Banner University Health and co-leader of the session, told 

 in an exclusive interview. “But it also allows all users to access the technology in terms of patient-specific anatomy and plaque composition to enhance the decision-making of all users and to further refine the care delivery pathway.”

Rizik and Morris discuss the Heartflow PCI Navigator, which analyzes CT scans to generate 3D models of calcium blockages ahead of procedures.

David Rizik, MD

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