SMT advances Hydra TAVI with skirted valve, AVDC 1.5

SMT advanced its transcatheter aortic valve implantation (TAVI) platform in January 2026 when Hydra Elevate received CDSCO approval, adding a polymeric external skirt to the Hydra valve, while AVDC 1.5 received CE approval in FY26 with a stated zero-lag, 1:1 deployment response.

What has SMT changed in the Hydra TAVI valve?

SMT has added a polymeric external skirt to Hydra Elevate while retaining the Hydra platform’s nitinol self-expanding frame, bovine leaflets and internal skirt. The external skirt is designed to seal the annulus, or valve opening area, and reduce paravalvular leak, which is leakage around an implanted valve. SMT lists Hydra Elevate, also described as TAVI 2.0, as having received CDSCO approval in January 2026.

Hydra Elevate retains the same frame, leaflets and internal skirt as Hydra, according to SMT’s product comparison. The update is therefore directed at annular sealing rather than a disclosed change to the valve frame or leaflet material. The existing Hydra valve also has a supra-annular leaflet position and is re-sheathable and repositionable.

The approval position differs between the two valve configurations. Hydra is listed with both a CE mark and CDSCO approval, whereas Hydra Elevate is listed with CDSCO approval. SMT does not disclose a CE mark for Hydra Elevate on the product page or provide a commercial launch date for the newer skirted configuration.

SMT presents the external skirt as a design intended to reduce paravalvular leak, rather than as a reported clinical outcome. The presentation does not disclose a Hydra Elevate leak rate, a comparator leak rate for Hydra, or patient results specifically from the January 2026 approved configuration.

What clinical record supports SMT’s Hydra iterations?

SMT’s disclosed Hydra development sequence begins with a 15-patient first-in-man experience in 2017 and includes a 40-patient Genesis study in 2021, followed by a 157-patient Hydra CE study in 2022. The platform was acquired with Vascular Concepts / Innovations in 2020, placing the subsequent valve and delivery-system work within SMT’s ownership timeline.

The latest clinical outcome figure in the presentation is from Genesis-II in 2024, which reported permanent pacemaker implantation (PPI) of 7.5% at 30 days. PPI refers to the implantation of a permanent pacemaker. SMT does not provide a corresponding PPI figure for the 2017 first-in-man cohort, the 2021 Genesis study or the 2022 Hydra CE study.

The patient count rose from 40 in the Genesis study to 157 in the Hydra CE study, a difference of 117 patients across the two disclosed studies. However, the presentation supplies patient counts for those earlier programmes and a 30-day PPI rate for Genesis-II, rather than common outcome measures across all cohorts. It therefore supports a record of continued iteration, but not a calculation of changes in leak rates, mortality or PPI between the studies.

How does AVDC 1.5 change TAVI deployment?

SMT says AVDC 1.5 delivers a direct 1:1 response between the deployment knob and capsule, reducing lag to zero. The next-generation delivery system received CE approval in FY26 and is listed with CE mark and CDSCO approvals. AVDC 1.5 is an upgrade to AVDC 1.0, the patented delivery system developed after the Vascular Innovations acquisition.

The redesigned system uses a braided capsule, compared with the existing AVDC 1.0 configuration. SMT says this design, together with the zero-lag release, reduces the gap between knob movement and capsule response. The company also says AVDC 1.5 requires fewer rotations to deploy, describing the intended result as simpler and faster deployment.

AVDC 1.5 also has a longer in-line sheath, which SMT says is intended to improve coaxial tracking and stability during delivery. Its more robust shaft is intended to provide greater pushability through the delivery path. These are stated design and handling characteristics; SMT does not disclose procedure-time data, bench-test measurements or comparative clinical results for AVDC 1.5.

The two delivery systems differ in their disclosed regulatory and design status. AVDC 1.0 is listed with CE mark and CDSCO approvals, while AVDC 1.5 is listed as the next-generation system with CE approval received in FY26 and the same stated approval markers. SMT also identifies an ergonomic redesign in AVDC 1.5 intended to improve the implanting physician’s user experience.

What approvals remain unresolved for SMT’s Hydra platform?

SMT’s European Union Medical Device Regulation (EU MDR) progress table shows Hydra at the technical-file review stage, with the technical file submitted to PCBC and first reviewer questions answered. Stage I and Stage II audits remained pending in the disclosed table. This review status is separate from the CE mark and CDSCO approval listed for the established Hydra valve.

The EU MDR transition period ends on 31 December 2027. SMT does not state a target certification date for Hydra, and the pending audit stages mean the presentation does not identify Hydra as EU MDR certified. Of the five products shown in the table, Supraflex Cruz was certified, while Pipit NC and Pipit SC had completed both audit stages and Hydra and Cocoon remained at technical-file review.

The January 2026 CDSCO approval for Hydra Elevate and FY26 CE approval for AVDC 1.5 are therefore component-specific milestones. They do not establish EU MDR certification for Hydra, because that process has separate submitted, audit and certification stages under SMT’s disclosed regulatory tracker.

Conclusion

SMT’s Hydra platform update combines a valve-side sealing modification with a delivery-system redesign. Hydra Elevate preserves the existing Hydra frame, leaflets and internal skirt while adding an external polymeric skirt intended to seal the annulus. AVDC 1.5 adds a braided capsule, stated zero-lag response, fewer deployment rotations, a longer in-line sheath and a more robust shaft.

The next disclosed regulatory matter is Hydra’s EU MDR process, where technical-file review had begun but both audit stages remained pending ahead of the 31 December 2027 transition deadline. Readers can also watch for any clinical evidence on the skirt’s effect on paravalvular leak and for product commercialisation details, neither of which SMT provides in this presentation.