TriSalus Life Sciences Announces New CMS HCPCS Code for TriNav® Infusion System Mapping
TriSalus Life Sciences (Nasdaq: TLSI) has secured a new Level II HCPCS code (C8004) from the Centers for Medicare & Medicaid Services for its TriNav® Infusion System, effective April 1, 2025. The code specifically covers simulation angiograms used in pre-treatment mapping for transarterial radioembolization (TARE).
The new code, which carries a Medicare payment rate of $11,341 under APC 5193, will be applicable in hospital outpatient departments and ambulatory surgical centers. This development validates TriNav's role in optimizing Y90 dose delivery and ensures reimbursement clarity for both mapping and treatment procedures.
The pressure-generating catheter system features a one-way valve technology that enhances the accuracy of Y90 dose delivery and improves personalized dosimetry through better prediction capabilities and higher tumor-to-normal tissue ratios.
TriSalus Life Sciences (Nasdaq: TLSI) ha ottenuto un nuovo codice HCPCS di Livello II (C8004) dai Centers for Medicare & Medicaid Services per il suo TriNav® Infusion System, a partire dal 1 aprile 2025. Il codice copre specificamente gli angiogrammi di simulazione utilizzati nella mappatura pre-trattamento per la radioembolizzazione transarteriale (TARE).
Il nuovo codice, che prevede un tasso di pagamento Medicare di $11,341 sotto l'APC 5193, sarà applicabile nei reparti ambulatoriali degli ospedali e nei centri chirurgici ambulatoriali. Questo sviluppo convalida il ruolo di TriNav nell'ottimizzare la somministrazione della dose di Y90 e garantisce chiarezza nei rimborsi sia per le procedure di mappatura che di trattamento.
Il sistema di catetere generatore di pressione presenta una tecnologia a valvola unidirezionale che migliora l'accuratezza della somministrazione della dose di Y90 e migliora la dosimetria personalizzata attraverso migliori capacità predittive e rapporti più elevati tra tumore e tessuto normale.
TriSalus Life Sciences (Nasdaq: TLSI) ha conseguido un nuevo código HCPCS de Nivel II (C8004) de los Centros de Servicios de Medicare y Medicaid para su TriNav® Infusion System, que entrará en vigor el 1 de abril de 2025. El código cubre específicamente los angiogramas de simulación utilizados en la mapeo previo al tratamiento para la radioembolización transarterial (TARE).
El nuevo código, que tiene una tasa de pago de Medicare de $11,341 bajo el APC 5193, será aplicable en los departamentos ambulatorios de hospitales y en centros quirúrgicos ambulatorios. Este desarrollo valida el papel de TriNav en la optimización de la entrega de dosis de Y90 y asegura claridad en el reembolso tanto para los procedimientos de mapeo como de tratamiento.
El sistema de catéter generador de presión presenta una tecnología de válvula unidireccional que mejora la precisión de la entrega de dosis de Y90 y mejora la dosimetría personalizada mediante mejores capacidades de predicción y mayores proporciones entre el tumor y el tejido normal.
TriSalus Life Sciences (Nasdaq: TLSI)는 2025년 4월 1일부터 시행되는 TriNav® Infusion System을 위해 Medicare 및 Medicaid 서비스 센터로부터 새로운 II급 HCPCS 코드(C8004)를 확보했습니다. 이 코드는 전신 동맥 내 방사선 색전술(TARE)을 위한 치료 전 매핑에 사용되는 시뮬레이션 혈관 조영술을 구체적으로 다룹니다.
새로운 코드는 APC 5193에 따라 Medicare 지급률이 $11,341이며, 병원 외래 진료 부서 및 외래 수술 센터에서 적용됩니다. 이 개발은 Y90 용량 전달 최적화에 대한 TriNav의 역할을 검증하고 매핑 및 치료 절차에 대한 보상 명확성을 보장합니다.
압력 생성 카테터 시스템은 Y90 용량 전달의 정확성을 향상시키고 더 나은 예측 능력과 높은 종양 대 정상 조직 비율을 통해 개인화된 선량계산을 개선하는 일방향 밸브 기술을 특징으로 합니다.
TriSalus Life Sciences (Nasdaq: TLSI) a obtenu un nouveau code HCPCS de niveau II (C8004) des Centers for Medicare & Medicaid Services pour son TriNav® Infusion System, qui entrera en vigueur le 1er avril 2025. Ce code couvre spécifiquement les angiogrammes de simulation utilisés dans la cartographie pré-traitement pour la radioembolisation transartérielle (TARE).
Le nouveau code, qui prévoit un taux de paiement Medicare de 11 341 $ dans le cadre de l'APC 5193, sera applicable dans les départements ambulatoires des hôpitaux et dans les centres chirurgicaux ambulatoires. Ce développement valide le rôle de TriNav dans l'optimisation de l'administration de la dose de Y90 et garantit une clarté de remboursement tant pour les procédures de cartographie que de traitement.
Le système de cathéter générateur de pression présente une technologie de valve unidirectionnelle qui améliore la précision de l'administration de la dose de Y90 et améliore la dosimétrie personnalisée grâce à de meilleures capacités de prédiction et à des rapports plus élevés entre la tumeur et le tissu normal.
TriSalus Life Sciences (Nasdaq: TLSI) hat einen neuen HCPCS-Code der Stufe II (C8004) von den Centers for Medicare & Medicaid Services für sein TriNav® Infusion System erhalten, der ab dem 1. April 2025 in Kraft tritt. Der Code deckt speziell Simulationsangiogramme ab, die bei der prätherapeutischen Kartierung für die transarterielle Radioembolisation (TARE) verwendet werden.
Der neue Code, der eine Medicare-Zahlungsrate von $11,341 unter APC 5193 vorsieht, wird in den ambulanten Abteilungen von Krankenhäusern und in ambulanten chirurgischen Zentren anwendbar sein. Diese Entwicklung validiert die Rolle von TriNav bei der Optimierung der Y90-Dosierungsabgabe und gewährleistet Klarheit bei der Erstattung sowohl für die Kartierungs- als auch für die Behandlungsverfahren.
Das druckerzeugende Kathetersystem verfügt über eine Einwegventiltechnologie, die die Genauigkeit der Y90-Dosierungsabgabe verbessert und die personalisierte Dosimetrie durch bessere Vorhersagefähigkeiten und höhere Tumor-zu-normalem Gewebe-Verhältnisse verbessert.
- Secured new CMS reimbursement code with substantial payment rate of $11,341
- Validation of technology's clinical value in radioembolization procedures
- Expanded market access through coverage in both HOPDs and ASCs
- Implementation delayed until April 2025
Insights
The new CMS HCPCS code C8004 for TriSalus' TriNav Infusion System represents a significant reimbursement milestone with substantial commercial implications. With an assigned payment rate of
This development removes a critical adoption barrier for TriNav by addressing reimbursement uncertainty - historically one of the most significant hurdles in medical technology commercialization. The code's implementation in hospital outpatient departments and ambulatory surgical centers provides legitimacy to the technology's clinical utility in radioembolization workflows.
The specific recognition of pressure-generating catheter technology for mapping procedures signals CMS's acknowledgment of the approach's distinct value. For interventional radiologists treating liver cancer patients with Y90 radioembolization, this code enables the use of consistent technology across both mapping and treatment phases without financial penalty.
From a revenue perspective, this approval creates a predictable payment structure that should accelerate institutional adoption decisions. The code's effective date of April 1, 2025 provides a clear timeline for potential revenue impact, with the
The new CMS mapping procedure code for TriNav represents meaningful clinical validation for pressure-directed delivery in radioembolization workflows. In Y90 radioembolization, the mapping procedure is critical for treatment planning - it determines microsphere distribution patterns and helps calculate appropriate radiation doses for tumor targeting.
The technical advantage of pressure-directed technology lies in its ability to modify blood flow dynamics during procedures. Dr. Marshall's statement about achieving higher tumor-to-normal tissue (T:N) ratios with TriNav is particularly significant - this metric directly correlates with treatment efficacy and safety. Higher T:N ratios allow for delivering more radiation to tumors while sparing healthy liver tissue.
The concordance between mapping and treatment phases mentioned in the article addresses a key technical challenge in radioembolization. When different catheters are used between planning and delivery phases, catheter positioning variations can lead to discrepancies between intended and actual dose distribution. Using identical technology for both steps potentially improves targeting precision.
This reimbursement development enables physicians to standardize their approach across the entire radioembolization procedure without financial considerations dictating catheter selection. For liver cancer patients undergoing these procedures, this could translate to more consistent and optimized treatment delivery, particularly important in complex vascular anatomy cases where standard catheters may provide suboptimal access.
The introduction of C8004 provides validation of TriNav’s growing role in pre-treatment mapping for Transarterial Radioembolization, reinforcing its value in optimizing
“With this new code, Interventional Radiologists and Medicare patients have access to PEDD for radioembolization procedures with full reimbursement for both mapping and treatment,” said Mary Szela, CEO of TriSalus. “Using PEDD technology for both the mapping and treatment procedures in radioembolization helps ensure accurate treatment planning and delivery which is crucial for delivering the radioactive microspheres to the tumor with precision.”
Dr. Richard Marshall, who serves as Medical Director for TriSalus, stated:
“In my current practice, using the same catheter for both mapping and treatment helps enhance the accuracy of
HCPCS Code C8004 Details
- Description: Simulation angiogram utilizing a pressure-generating catheter (e.g., one-way valve, intermittently occluding), including all radiological supervision and interpretation, intraprocedural road mapping, and imaging guidance necessary for subsequent therapeutic radioembolization of tumors.
- Effective Date: April 1, 2025
- Eligible Reporting Facilities: Hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs)
-
Medicare Payment Rate:
$11,341
TriSalus’ initial analysis indicates that the reimbursement level under C8004, combined with standard Medicare payment adjustments, will support continued adoption of TriNav for both mapping and treatment.
For more information, the full CMS Quarterly Update can be found [here].
About TriSalus Life Sciences
TriSalus Life Sciences® is a growing, oncology focused medical technology business bringing disruptive drug delivery technology with the goal of improving therapeutic delivery to liver and pancreatic tumors. Additionally, we are exploring the integration of our technology with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of liver and pancreatic indications. Our ultimate goal is to transform the treatment paradigm for patients battling liver and pancreatic tumors. We have developed an innovative organ-specific platform that is designed to overcome two of the most significant challenges that prevent optimal delivery and performance of therapeutics in these difficult-to-treat diseases: (i) high intratumoral pressure caused by tumor growth and collapsed vasculature restricting the delivery of oncology therapeutics and (ii) the immunosuppressive properties of liver and pancreatic tumor immune cells. By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes.
In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby under the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “become,” “may,” “intend,” “will,” “expect,” “anticipate,” “believe” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding TriSalus’s business, the commercial potential of its TriNav Infusion System, TriSalus’s proprietary PEDD approach, the potential therapeutic benefits and commercial potential of Nelitolimod, and TriSalus’s technologies and other products in development. Such statements are subject to certain risks and uncertainties, including, but not limited to, those inherent in the process of developing and commercializing medical devices that are safe and effective for human use, discovering, developing and commercializing medicines that are safe and effective to use as human therapeutics, and the endeavor of building a business around such medical devices and medicines.
TriSalus’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although TriSalus’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by TriSalus. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning TriSalus’s products and programs are described in additional detail in TriSalus’s annual report on Form 10-K, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission (the "SEC") and available at the SEC's website (www.SEC.gov). These forward-looking statements are made as of the date of this press release, and TriSalus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/quarterly-update
View source version on businesswire.com: https://www.businesswire.com/news/home/20250326932769/en/
For Media Inquiries:
Jeremy Feffer, Managing Director
LifeSci Advisors
917.749.1494
jfeffer@lifesciadvisors.com
For Investor Inquiries:
James Young
Chief Financial Officer
847.337.0655
james.young@trisaluslifesci.com
Source: TriSalus Life Sciences
FAQ
What is the new CMS reimbursement rate for TLSI's TriNav mapping procedures?
When will the new HCPCS code C8004 for TLSI's TriNav System become effective?
Which healthcare facilities can use TLSI's new TriNav reimbursement code?
What clinical benefits does TLSI's TriNav system offer for radioembolization procedures?
