New Heartflow PCI Navigator to Equip Interventional Cardiologists with Pre-procedural Insights to Enable PCI Planning
Heartflow (Nasdaq: HTFL) introduced PCI Navigator, an AI-driven CT-guided PCI planning tool that combines patient-specific 3D anatomy, plaque composition and lesion-specific physiology in a single web-based view to help plan stent placement.
New PLAN CALCIUM data (TCT 2025) found that adding AI plaque analysis to coronary CTA/FFRCT altered calcium modification plans in >50% of lesions. Heartflow will launch the NAVIGATE-PCI registry in 2026 to enroll ~2,500 patients across ~30 U.S. sites, with broader commercial availability planned later in 2026.
Heartflow (Nasdaq: HTFL) ha introdotto PCI Navigator, uno strumento di pianificazione PCI guidato da AI basato su CT che combina l’anatomia 3D specifica del paziente, la composizione della placca e la fisiologia specifica della lesione in una singola visualizzazione web per aiutare a pianificare l'inserimento dello stent.
I nuovi dati PLAN CALCIUM (TCT 2025) hanno rilevato che aggiungere l’analisi AI della placca alla CTA coronarica/FFRCT ha modificato i piani di modifica del calcio in >50% delle lesioni. Heartflow lancerà il registro NAVIGATE-PCI nel 2026 per arruolare ~2.500 pazienti in ~30 siti negli Stati Uniti, con una disponibilità commerciale più ampia prevista più avanti nel 2026.
Heartflow (Nasdaq: HTFL) presentó PCI Navigator, una herramienta de planificación de PCI guiada por IA basada en CT que combina la anatomía 3D específica del paciente, la composición de la placa y la fisiología específica de la lesión en una única vista web para ayudar a planificar la colocación del stent.
Los nuevos datos PLAN CALCIUM (TCT 2025) indicaron que añadir el análisis de placa con IA a la CTA coronaria/FFRCT modificó los planes de modificación del calcio en más del 50% de las lesiones. Heartflow lanzará el registro NAVIGATE-PCI en 2026 para inscribir ~2,500 pacientes en ~30 sitios en EE. UU., con una disponibilidad comercial más amplia prevista para más adelante en 2026.
Heartflow (나스닥: HTFL)는 AI 기반 CT 안내 PCI 계획 도구인 PCI Navigator를 도입했습니다. 이는 환자별 3D 해부학, 플라크 구성 및 병변 특이 생리학을 하나의 웹 기반 화면으로 결합하여 스텐트 배치를 계획하는 데 도움을 줍니다.
새 PLAN CALCIUM 데이터(TCT 2025)에 따르면 AI 플라크 분석을 관상동맥 CTA/FFRCT에 추가하면 칼슘 수정 계획이 50% 이상인 병변에서 변경되었습니다. Heartflow는 2026년에 NAVIGATE-PCI 레지스트리를 시작하여 약 2,500명의 환자를 미국 내 약 30곳의 사이트에서 등록하고, 2026년 말에 더 넓은 상업적 가용성을 계획하고 있습니다.
Heartflow (NASDAQ : HTFL) a présenté PCI Navigator, un outil de planification PCI guidé par l'IA basé sur CT qui combine l’anatomie 3D spécifique au patient, la composition de la plaque et la physiologie spécifique à la lésion dans une vue web unique pour aider à planifier le placement d'un stent.
De nouvelles données PLAN CALCIUM (TCT 2025) ont montré que l’ajout de l’analyse IA de la plaque à la CTA coronarienne/FFRCT modifiait les plans de modification du calcium dans plus de 50% des lésions. Heartflow lancera le registre NAVIGATE-PCI en 2026 pour enrôler environ 2 500 patients dans environ 30 sites américains, avec une disponibilité commerciale plus large prévue plus tard en 2026.
Heartflow (NASDAQ: HTFL) führte PCI Navigator ein, ein KI-gesteuertes CT-gesteuertes PCI-Planungstool, das patientenspezifische 3D-Anatomie, Plaque-Zusammensetzung und leisonenspezifische Physiologie in einer einzigen webbasierten Ansicht kombiniert, um die Stent-Positionierung zu planen.
Neue PLAN CALCIUM-Daten (TCT 2025) ergaben, dass die zusätzliche KI-Plackenanalyse zur koronaren CTA/FFRCT die Kalzium-Modifikationspläne bei über 50 % der Läsionen veränderte. Heartflow wird im Jahr 2026 das NAVIGATE-PCI-Register starten, um ca. 2.500 Patienten an ca. 30 US-Standorten zu rekrutieren, mit späterer, breiterer kommerzieller Verfügbarkeit geplant.
Heartflow (ناسداك: HTFL) قدمت PCI Navigator، أداة تخطيط PCI مدفوعة بالذكاء الاصطناعي وموجهة بـ CT، تجمع بين تشريح ثلاثي الأبعاد خاص بالمريض وتكوين اللويحات والفسيولوجيا المرتبطة بالآفة في عرض ويب واحد للمساعدة في تخطيط وضع الدعامة.
تشير بيانات PLAN CALCIUM الجديدة (TCT 2025) إلى أن إضافة تحليل اللوحات بالذكاء الاصطناعي إلى CTA التاجية/FFRCT غيرت خطط تعديل الكالسيوم في أكثر من 50% من الآفات. ستطلق Heartflow سجل NAVIGATE-PCI في 2026 لتسجيل نحو 2,500 مريض عبر نحو 30 موقعًا في الولايات المتحدة، مع تخطيط لتوفر تجاري أوسع لاحقًا في 2026.
Heartflow（纳斯达克：HTFL） 推出 PCI Navigator，一款由 AI 驱动的 CT 指引 PCI 规划工具，将患者特异的三维解剖结构、斑块组成和病变特异性生理学整合在一个网页视图中，帮助规划支架放置。
新的 PLAN CALCIUM 数据（TCT 2025）显示，将 AI 斑块分析添加到冠状动脉 CTA/FFRCT 中，会改变超过 50% 病变的钙化修饰计划。Heartflow 将在 2026 年启动 NAVIGATE-PCI 注册，计划在约 30 个美国站点招募约 2,500 例患者，随后在 2026 年晚些时候实现更广泛的商业可用性。
- PLAN CALCIUM: altered calcium modification plans in >50% of lesions
- NAVIGATE-PCI: registry to enroll ~2,500 patients across ~30 U.S. sites
- Integrated planning: combines anatomy, plaque composition and lesion physiology in one web-based view
- Commercial timeline: broader clinical use expected before commercial availability later in 2026
- Not yet commercial: broader availability slated only for later in 2026
- Evidence focus: PLAN CALCIUM reports changes in procedural plans, not clinical outcome data
Insights
Heartflow launches an AI-driven PCI planning tool backed by study data and a 2,500-patient registry to evaluate CT-guided PCI in practice.
Heartflow PCI Navigator consolidates anatomy, plaque composition and lesion-specific physiology into a pre-procedural 3D view aimed at guiding stent placement and calcium modification decisions. The PLAN CALCIUM data presented at TCT show that adding AI plaque analysis to CCTA/FFRCT and angiography changed calcium modification plans in over half of lesions, a concrete operational signal that the tool can alter procedural plans.
Key dependencies and risks include the generalizability of PLAN CALCIUM findings beyond the study sample and whether NAVIGATE-PCI, enrolling ~2,500 patients across ~30 sites beginning in
Items to watch: the PLAN CALCIUM presentation at TCT on
PLAN CALCIUM study to be presented at TCT 2025 conference highlights how AI-powered plaque analysis can inform lesion preparation and calcium modification planning
NAVIGATE-PCI registry to enroll approximately 2,500 patients across approximately 30 sites to evaluate the impact of CT-guided PCI planning in real-world practice
MOUNTAIN VIEW, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today introduced Heartflow PCI Navigator, the newest addition to the Heartflow One platform. PCI Navigator is the only integrated, AI-driven percutaneous coronary interventions (PCI) planning tool that gives interventional cardiologists a patient-specific 3D model — detailing anatomy, plaque composition, and lesion-specific physiology — all aligned to optimize potential stent placement. For the first time, interventional cardiologists can plan PCIs with relevant information brought together in one intuitive view before their patients are in the cath lab.
Heartflow will showcase PCI Navigator with live demonstrations at Heartflow’s exhibit booth (#2155) at the upcoming Transcatheter Cardiovascular Therapeutics (TCT®) conference, taking place from October 25-28, 2025, in San Francisco. The company will also present the PLAN CALCIUM study (abstract TCT 417) at the conference on October 26 at 8:30 a.m. PDT.
PCI Navigator delivers a streamlined view of essential information for cath lab decision-making by integrating all relevant measurements — including IVUS-like and FFR-like pullback visualizations — into one seamless experience, which typically requires significant time and effort to obtain in the cath lab.
“Interventional cardiologists make some of the most critical decisions in coronary care, often with limited information before a case begins. CT-guided PCI addresses that information gap, harnessing insights from the CCTA pathway into a pre-procedural plan to provide physicians the clarity they need for each case. PCI Navigator puts Heartflow at the forefront of that shift,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of Heartflow. “CCTA with Heartflow analysis helps ensure that all patients warranting invasive management are directed to the cath lab, while also reducing invasive angiograms and improving efficiency. PCI Navigator enhances planning for these patients by integrating anatomy, plaque, and lesion-specific physiology for the interventionalist’s review and input before the procedure.”
PCI Navigator Will Deliver a Streamlined View of Essential Information for Cath Lab Decision-making
This includes:
- Procedural Complexity: Lesion-specific FFRCT values, stenosis, plaque location and composition, as well as percent myocardium fed by a vessel, to help understand lesion significance in context.
- Stent Landing Zones: Cross-sectional and longitudinal reconstructions providing lumen diameter and length measures alongside plaque morphology and stenosis severity to help precisely plan and guide procedures.
- Planning for Optimal Outcomes: Physiology changes along the lesion (ΔFFRCT) to ensure the stenting procedure addresses the maximal flow gradient for optimal outcomes.
By bringing together information that interventional cardiologists need to plan procedures into a web-based interface, PCI Navigator may help streamline procedures with increased efficiency and clinical confidence for both patients and staff.
PLAN CALCIUM Study Data to Be Presented at TCT 2025
Heartflow’s technology will be featured in new data from the PLAN CALCIUM Study. The study evaluated how pairing Heartflow Plaque Analysis insights with coronary CTA imaging and FFRCT analysis influenced the decisions of interventional cardiologists undertaking PCI in highly calcified lesions. The addition of AI-powered plaque analysis to coronary CTA, FFRCT and angiography altered plans for calcium modification in over half of lesions, demonstrating the growing potential for CT-guided planning to drive more precise coronary interventions.
“Incorporating AI-driven plaque analysis into coronary CTA and lesion-specific FFRCT workflows has great potential to change how we think about lesion preparation,” said Ankitkumar Patel, M.D., M.P.H., Medical Director of the Cardiac Catheterization Laboratory at Hackensack Meridian Mountainside Medical Center, Montclair, NJ. “PLAN CALCIUM data suggest that having information about plaque composition and distribution available ahead of time can help clinicians make more informed decisions about calcium modification and device selection for our patients.”
Heartflow to Initiate NAVIGATE-PCI Registry in 2026
The NAVIGATE-PCI Registry will enroll more than 2,500 patients across approximately 30 U.S. sites to assess how PCI Navigator influences physician confidence, procedural safety and efficiency, strategy and patient outcomes compared to standard care.
“The NAVIGATE-PCI study is designed to address a major unmet need in how we plan and perform PCI in clinical practice,” said Ziad Ali, M.D., D.Phil., Director of the DeMatteis Cardiovascular Institute at St. Francis Hospital & Heart Center, and Co-Principal Investigator of the study. “By evaluating CT-guided PCI planning using Heartflow PCI Navigator, we aim to better understand how this technology can reshape everyday interventional practice and elevate patient care.”
Broader clinical use of PCI Navigator is expected to begin with the NAVIGATE-PCI registry, followed by commercial availability later in 2026.
About Heartflow’s Technology and Research
Backed by ACC/AHA guidelines and over 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for nearly 500,000 patients worldwide. Our continuous innovation is driven by an unmatched proprietary data pipeline built from over 110 million annotated CTA images. Heartflow’s AI-driven solutions have been extensively validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed
About Heartflow, Inc.
Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com.
Media Contact
Elliot Levy
elevy@heartflow.com
Investor Contact
Nick Laudico
nlaudico@heartflow.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8d62cfec-2cb8-4c89-81bc-eac3f7c1ec44
FAQ
What is Heartflow PCI Navigator and how does it help interventional cardiologists (HTFL)?
What did the PLAN CALCIUM study presented at TCT 2025 report about HTFL technology?
When will Heartflow (HTFL) start the NAVIGATE-PCI registry and how many patients will it enroll?
Will PCI Navigator be commercially available immediately after the NAVIGATE-PCI registry?
Does PLAN CALCIUM show improved patient outcomes from using Heartflow PCI Navigator (HTFL)?
