Carvolix submits 510(k) for TAVIPILOT Robot, advancing toward US commercial launch of Its Integrated TAVIPILOT Platform.
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Affluent Medical Carvolix submits 510(k) for TAVIPILOT Robot, advancing toward US commercial launch of Its Integrated TAVIPILOT Platform. 22-Sep-2026 / 17:45 CET/CEST Dissemination of a French Regulatory News, transmitted by EQS Group. The issuer is solely responsible for the content of this announcement. Carvolix submits 510(k) for TAVIPILOT Robot, advancing toward US commercial launch of Its Integrated TAVIPILOT Platform.
Aix-en-Provence, September 22, 2026 – 17:45 CET – Carvolix (formerly Affluent Medical) (ISIN: FR0013333077 – Ticker: CVX), a French medical devices company at the commercial stage, specializing in the development of AI-driven mini-robots and biomimetic implants, announces the filing of a 510(k) submission with the U.S. Food and Drug Administration (FDA) for the TAVIPILOT Robot, the robotic component of its integrated TAVIPILOT platform to augment transcatheter aortic valve replacement (TAVI) procedures. This is a key regulatory submission required before Carvolix can bring the integrated TAVIPILOT platform to the US market. Continued progress toward commercialization of the integrated TAVIPILOT platform The TAVIPILOT platform brings together:
"With this new regulatory step, we are executing against our clinical and commercial roadmaps, each one bringing us closer to the same goal: to democratize access to complex cardiovascular procedures," said Sébastien Ladet, CEO of Carvolix. He continued: "Our AI-driven robotic platform is not a single-feature product. Precision positioning is the first commercial feature we deliver, but the same software and robotic architecture is designed to host additional intra-procedural capabilities. Building a platform, not a single product, is how we scale value delivery to each cath-lab we will equip.” Potential US market growth with supportive coverage update The US regulatory and reimbursement environment is evolving in favor of wider access to TAVI procedures. On September 10, 2026, the Centers for Medicare & Medicaid Services (CMS) published its final national coverage determination for transcatheter aortic valve replacement, easing requirements for patients with symptomatic severe aortic stenosis: hospital procedural volume thresholds are removed, and coverage with evidence development no longer applies to this population. The updated determination also allows procedures to be performed by a single operator where previously two operators were required. In addition, coverage is extended to patients with asymptomatic severe aortic stenosis under evidence development. More centers are expected to become eligible to offer TAVI as a result, with a need to scale up. Against a backdrop in which only 17% of eligible patients are treated each year, Carvolix believes this reinforces the need for technologies such as TAVIPILOT that make procedures more precise, reproducible while shortening the learning curve for interventional teams. An FDA submission supported by the completed ROTAO1 study The filing follows the completion of the ROTAO1 First-in-Human study, which evaluated the robotic building block of the TAVIPILOT platform in 10 patients undergoing TAVI procedures. ROTAO1 was a prospective First-in-Human study assessing the feasibility, safety and technical reliability of the AI-driven TAVIPILOT Robot, without the software, during transfemoral TAVI procedures. It was conducted by Professor Stephen Worthley, MD, PhD, interventional cardiologist, and his team at Macquarie University Hospital, Sydney, Australia. Ten consecutive patients with symptomatic severe aortic stenosis (mean age 82.9 years; median EuroSCORE II 3.45) were treated with balloon-expandable valves. “The system performed successfully in every case, which is very encouraging in a first-in-human trial. It gave us stable, consistent catheter control and supported precise valve positioning, while every clinical decision stayed with the operator. These are preliminary results, but they justify continuing the clinical development of robotically assisted TAVI, as only a fraction of patients who could benefit from this procedure are treated today”, said Professor Stephen Worthley, MD, PhD, Principal Investigator of ROTAO1, Macquarie University Hospital, Sydney. Robotic-assisted navigation and valve positioning were successfully performed in all 10 procedures. The TAVIPILOT Robot functioned successfully in 100% of procedures, with no failure to connect the delivery system or the single-use cassette, no navigation failure, and no unexpected robot behaviour. No serious adverse event was considered related to the TAVIPILOT Robot. All 10 patients completed their 1-month follow-up, with no death and no study withdrawal, and clinician satisfaction was consistently high throughout the study, with a mean satisfaction score of 8.0/10. Investigators consistently agreed or strongly agreed that the robot provided enhanced stabilization of the catheter and consistent movements, responded accurately to commands, and facilitated precise valve positioning. A growing body of clinical evidence Carvolix is continuing the clinical development of the platform through the SAIRO study, which evaluates the combined use of the TAVIPILOT Robot and the TAVIPILOT Software in open-loop, AI-guided use during TAVI procedures. The software provides the operator with real-time analysis of anatomical landmarks and valve position, while the robot enables precise, controlled movements under clinical supervision. Interim analysis of the first 7 of 20 planned patients, all successfully treated at Macquarie University Hospital (n=1) and St Vincent’s Hospital Sydney (n=6), showed high clinician satisfaction with the software and the integrated robot-guided workflow. No record of robot or software device deficiencies was reported. These preliminary findings support the continued clinical evaluation of the integrated TAVIPILOT platform. Together with the post-market data already reported for the TAVIPILOT Software, ROTAO1 and SAIRO progressively build the evidence base for each component of the platform and for their combined use in the cath-lab. Carvolix expects to complete the SAIRO cohort and to initiate a clinical cohort evaluating the TAVIPILOT platform in supervised autonomy[1] by the end of 2026. About the TAVIPILOT Robot The TAVIPILOT Robot is a robotic platform designed to assist with the navigation and positioning of transcatheter heart valves. The system allows the operator to precisely control catheter movements while retaining full control over clinical decisions and valve deployment. The TAVIPILOT Robot is a device under clinical development and is not authorized for commercial use. About the TAVIPILOT Software TAVIPILOT Software is an AI-powered real-time intra-procedural guidance software for percutaneous aortic valve implantation (TAVI). It provides automatic real-time detection of anatomical landmarks as well as continuous depth assessment during valve deployment. TAVIPILOT Software received FDA 510(k) clearance (K243884, July 2025) and commercial deployment in the United States began in H2 2025. A CE marking dossier was submitted in August 2026.
For more information: www.carvolix.eu Contacts
This press release contains forward-looking statements regarding Carvolix's clinical development, regulatory pathway, commercial plans and market estimates. These statements are based on current expectations and assumptions and involve known and unknown risks and uncertainties — including, but not limited to, those related to clinical trial results, sample sizes, follow-up data, regulatory approvals and market conditions — that could cause actual results to differ materially. The clinical results described concern a limited number of patients and remain subject to longer-term follow-up and publication following peer review. Forward-looking statements speak only as of the date of this press release, and Carvolix undertakes no obligation to update them, except as required by law. This press release does not constitute and shall not be construed as an offer or solicitation to subscribe for, buy or sell Carvolix securities in any jurisdiction. [1] in which the system performs the positioning sequence under the direct supervision of the operator, who retains control of every clinical decision.
Regulatory filing PDF file File: Carvolix_PR_TAVIPILOT_Robot_510k vFinal |
| Language: | English |
| Company: | Affluent Medical |
| 320 avenue Archimède, Les pléiades III Bâtiment B | |
| 13100 Aix en Provence France | |
| France | |
| Phone: | +33 4 42 95 12 20 |
| E-mail: | jerome.geoffroy@affluentmedical.com |
| Internet: | https://www.affluentmedical.com/ |
| ISIN: | FR0013333077 |
| Euronext Ticker: | AFME |
| AMF Category: | Inside information / Other releases |
| EQS News ID: | 2403420 |
| End of Announcement | EQS News Service |
2403420 22-Sep-2026 CET/CEST
GDCBHVIVSCKVGDYLSUBLKSNN_Carvolix_PR_TAVIPILOT_Robot_510k_vFinal.pdf