Three-zone adaptive frame.
A flexible outflow conforms to the aorta, the mid-frame supports bioprosthesis geometry, and the inflow provides radial strength for annular anchoring.
STRUCTURAL HEART · TAVI
TAVI SystemSupra-annular transcatheter aortic valve
Manufacturer: Vascular Innovations Co., Ltd. · SMT group
Adaptive frame.
Controlled implantation.Supra-annular technology and a three-zone nitinol frame. A platform that can be recaptured up to 80% of deployment.*
01 / THE BIOPROSTHESIS
A system for TAVI.
SELF-EXPANDINGAdaptive nitinol3 zones
MARKERS2 rowsof markers for positioning
and commissural alignment
and commissural alignment
TUBULAR INFLOWInternal sealing skirt12–14 mm in height
RECAPTURABLEUp to 80%of deployment: recapture and repositioning*
3 SIZES22, 26 and 30 mmAnnulus perimeters
from 53 to 85 mm
from 53 to 85 mm
THE HYDRA VALVE
Anatomical adaptability and precise implantation.
The supra-annular design combines bovine pericardial leaflets with a self-expanding frame featuring differentiated mechanical properties and optimal immediate and late hemodynamic performance.
Markers for positioning and orientation.
Two rows of radiopaque markers provide references for implantation depth and leaflet deployment. Commissural orientation is described in the dedicated case report.
Space for coronary access.
Trillium technology and the open geometry of the upper cells, with a minimum opening of 15 F, are designed to facilitate coronary reaccess.
*Recapture and repositioning up to 80% of deployment. Features and limitations depend on the configuration used: refer to the applicable instructions for use.
DELIVERY SYSTEM EVOLUTION
The new delivery system
HYDRA AVDC 1.5.
Flexible through sharp angles
and tortuous arteries.
Stable during deployment.
The braided capsule increases back-up support during THV tracking and control during deployment while maintaining high flexibility. The integrated 45 cm in-line sheath increases system stability during implantation.
The redesigned handle and knob offer a wider grip and require fewer rotations for deployment.
Watch the new delivery system ↗
Automatic 80% deployment stopper.
A checkpoint before final deployment to assess implantation depth and haemodynamics.
Active Release.
A dedicated control manages final deployment of the frame extensions, adding a specific control at the final stage.
Quick Resheath.
Rapid capsule advancement helps prepare the system for withdrawal.
CLINICAL EVIDENCE / PUBLICATIONS
Clinical evidence.
Follow-up up to 5 years.
HYDRA CE, GENESIS and GENESIS-II: haemodynamic and safety outcomes in the cohorts studied.
LONG-TERM FOLLOW-UP2026
HYDRA CE5 years
54 patients from 2 European centres, a subgroup of the 157-patient HYDRA CE cohort. Prospective, multicentre, single-arm study.
Reported outcomes
At 5 years: all-cause mortality 24.3%, cardiovascular mortality 6.0%; mean gradient 8.0 ± 3.14 mmHg; effective orifice area 2.09 ± 0.57 cm². New pacemaker implantation 16.7%. No structural valve deterioration was observed in this subgroup.
Interpreting these data +
Small, selected cohort without a control group: the result does not guarantee durability for every patient.
Bajoras et al. · Catheter Cardiovasc Interv. 2026;107:1782–1790.
DOI: 10.1002/ccd.70536
ACTIVE RELEASE MECHANISM2026
GENESIS-II6 months
40 patients, 19 centres in India. Prospective, multicentre, non-randomised study of HYDRA with active release.
Reported outcomes
Device success 95%. At 6 months: all-cause mortality 5.0%, cardiovascular mortality 2.5%; mean gradient 8.7 ± 3.3 mmHg and effective orifice area 1.9 ± 0.4 cm². The abstract reports new pacemaker implantation in 7.9%.
Interpreting these data +
Follow-up of the same cohort as the 30-day publication, not a new independent population. No randomised comparison.
Sonawane et al. · Indian Heart J. 2026;78:201–205.
DOI: 10.1016/j.ihj.2026.03.004
ACTIVE RELEASE MECHANISM2025
GENESIS-II30 days
40 patients at high surgical risk, 19 centres in India. Prospective, multicentre, non-randomised study.
Reported outcomes
Device success 95%; cardiovascular mortality 2.5%. Mean gradient 8.4 ± 4.0 mmHg; effective orifice area 1.9 ± 0.6 cm². New pacemaker: 3/40 (7.5%), or 7.9% among patients without a baseline pacemaker.
Interpreting these data +
Early follow-up and a small sample. The full text also reports one device embolisation requiring surgical reintervention.
Senguttuvan et al. · AsiaIntervention. 2025;11:155–163.
DOI: 10.4244/AIJ-D-24-00075
EXTENDED FOLLOW-UP2025
HYDRA CE3 years
54 patients from 2 European centres, selected from the HYDRA CE cohort for extended follow-up.
Reported outcomes
At 3 years: all-cause mortality 14.8%, cardiovascular mortality 3.7%; mean gradient 8.6 ± 2.80 mmHg and effective orifice area 1.97 ± 0.52 cm². New pacemaker implantation 12.9%.
Interpreting these data +
A subgroup, not all 157 original participants. This cohort continued into the 5-year publication.
Bajoras et al. · Catheter Cardiovasc Interv. 2025;105:292–300. Published online in 2024.
DOI: 10.1002/ccd.31285
PROSPECTIVE PRE-MARKET STUDY2022
HYDRA CE30 days / 1 year
157 patients, 18 centres in Europe and Asia-Pacific. Prospective, multicentre, single-arm study with independent event adjudication.
Reported outcomes
Successful implantation in 94.3%. All-cause mortality: 7.0% at 30 days and 14.6% at 1 year. Moderate/severe PVL: 6.3% and 6.9%; new pacemaker: 11.7% and 12.4%. Mean gradient at 30 days was 8.1 ± 3.7 mmHg.
Interpreting these data +
No comparison group; the population and study period should be considered when interpreting the results.
Aidietis et al. · JACC Cardiovasc Interv. 2022;15:93–104.
DOI: 10.1016/j.jcin.2021.09.004
INITIAL CLINICAL EVALUATION2021
GENESIS6 months
40 patients, 11 centres in India. Prospective, multicentre, single-arm study in patients at high or extreme surgical risk.
Reported outcomes
Device success 92.5%. All-cause mortality: 10.0% at 30 days and 17.5% at 6 months. New pacemaker implantation 7.5% at 30 days. At 6 months: mean gradient 7.6 ± 2.7 mmHg; no PVL greater than mild was reported.
Interpreting these data +
Small initial study of the HYDRA configuration available at the time. Distinct from GENESIS-II.
Chandra et al. · Catheter Cardiovasc Interv. 2021;98:371–379.
DOI: 10.1002/ccd.29733
EOA: effective orifice area. PVL: paravalvular leak. Data from the respective publications at the specified follow-up. Follow-up reports from the same cohort do not represent independent populations. Single-arm or non-randomised studies do not provide a direct comparison with other valves. GENESIS-II evaluates the active release mechanism; configurations and study periods may differ from earlier studies. Refer to the IFU for indications and safety information. Bibliography checked on 17 October 2026.
CLINICAL EXPERIENCE AND TRAINING
HYDRA in practice.
The product in action.
Clinical cases, imaging and demonstrations of the new delivery system. Select a video to play it on this site.
Published clinical cases
CASE REPORT EUROINTERVENTION · 2022
Commissural alignment
and coronary reaccess.
Marker orientation and coronary reaccess after HYDRA implantation. The case by Buono et al., published in EuroIntervention.
LIVE CASE CSC ESTRUCTURAL · 2024
HYDRA.
A live case from Salamanca.
Implantation with recapture and post-dilatation in the case presented at CSC Estructural 2024.
CASE REPORT CARDIOVASCULAR REVASCULARIZATION MEDICINE · 2023
Contrast-zero valve-in-valve
in severe chronic kidney disease.
HYDRA aortic valve-in-valve replacement without contrast in a patient with severe chronic kidney disease. The case report by Ielasi et al., published in Cardiovascular Revascularization Medicine.
Ielasi A, Buono A, Briguglia D, Uccello G, Pellicano M, Medda M, Tespili M. Cardiovasc Revasc Med. 2023;49:73–74. DOI: 10.1016/j.carrev.2022.08.020.
Read the publication ↗Cases document individual experiences. Clinical videos and delivery demonstrations are presented as separate categories; the instructions for use remain the reference for device use.
GISE 2026 · THE CATH LAB RELOADED
Operator interviews.
47TH GISE CONGRESS · 2026
Dr Alfonso Ielasi
Comments following “The Cath Lab Reloaded” symposium at the 47th GISE Congress 2026.
The Cath Lab Reloaded
Case reloaded: QFR and Hydra in action in TAVI patient
More operator interviews coming soon.
SIZING
Three sizes.
HYDRA 22, 26 and 30.
Annular treatment ranges and bioprosthesis dimensions.
Product images from the manufacturer's original materials. Dimensions and TEE ranges from brochure HYDRA/BRO/EN01 REV.03, “Size Matrix”, page 8. Refer to the applicable IFU for sizing.
ORDERING INFORMATION
Ordering information.
| Product code | Size |
|---|---|
| HYDRA22 | 22 mm |
| HYDRA26 | 26 mm |
| HYDRA30 | 30 mm |
DOCUMENTATION
HYDRA documentation.
Brochures, sizing diagrams and technical references.
PDF / ENPDF / ENPDF / ENEUKON
Dimensions and sizing · HYDRA 22 / 26 / 30
Prosthesis dimensions and anatomical recommendations from the technical document.
Manufacturer brochure
SMT / Vascular Innovations · HYDRA/BRO/EN01 REV.03 · ©2022
Commissural alignment
Buono et al. · EuroIntervention · 2022
Product details and references
Features and documentation in structural heart.
TRAINING AND SUPPORT
The EUKON team
supporting your centre.
HYDRA system information, product training and technical support for your TAVI team.
Contact the EUKON team ↗