Navitor TAVI Systems

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CARDIOVASCULAR

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Smart Sealing.
Exceptional Stability.
Uncompromised Access.

Navitor™ TAVI system offers intelligent design advantages, including smart PVL-sealing NaviSeal™ Cuff, stable and accurate placement, exceptional single-digit gradients,¹ and uncompromised small vessel access and coronary access to consistently achieve excellent outcomes across a spectrum of routine to challenging anatomies.

Intelligent Design.

NaviSeal Cuff actively synchronizes to the cardiac cycle, seals, and mitigates PVL¹ by expanding to fill calcification-related gaps between the annulus and the valve.
Non-tapered stent and large EOAs resulting in single-digit gradients are associated with improved cardiac function, long-term durability, and minimal prosthesis-patient mismatch.¹
The only self-expanding valve with intra-annular leaflets that immediately function and a non-tapered stent, providing hemodynamic stability for a calm and controlled deployment.
Exclusive Linx™ anticalcification (AC) technology resists calcification in four distinct ways to improve long-term valve performance.*^2-5
Large-cell geometry and intra-annular valve design preserve coronary access for future intervention.

Stability and Accuracy.

Low profile and highly flexible catheter enables excellent deliverability, even in patients with small access vessels and tortuous anatomies.
14 F** delivery system with 5.0 mm minimum vessel diameter.
Controlled deployment provides stable and accurate valve placement.
Recapturable,*** repositionable,*** and retrievable*** design.

Excellent 30-Day Outcomes.¹

79.7% None/Trace Paravalvular Leak (PVL)^†
20.3% Mild PVL^†
0% Moderate to Severe PVL^†
2.0 cm² Effective Orifice Area^†
7.4 mmHg Mean Gradient^†
0% All-Cause Mortality
0.8% Disabling Stroke
2.5% Life-Threatening Bleeding
1.7% Acute Kidney Injury Stage 2/3
0.8% Major Vascular Complications
15.0% New Permanent Pacemaker Implantation

Learn more about Navitor™ TAVI System by visiting the Abbott Structural Heart website

Ordering Information

Navitor™ Transcatheter Aortic Valve

Catalog Number	Valve Size (mm)	Annulus Use Range Diameter (mm)⁶	Annulus Area (mm²)⁶	Annulus Perimeter (mm)⁶
NVTR-23	23 MM	19-21 MM	277–346 MM	60–66 MM
NVTR-25	25 MM	21–23 MM	338–415 MM	66–73 MM
NVTR-27	27 MM	23–25 MM	405–491 MM	72–79 MM
NVTR-29	29 MM	25–27 MM	479–573 MM	79–85 MM

FlexNav™ Delivery System

Catalog Number	Equivalent Integrated Sheath Diameter (F)⁶	Valve Capsule Outer Diameter (mm)⁶	Integrated Sheath Working Length (cm)⁶	Delivery System Working Length (cm)⁶	Minimum Vessel Diameter Requirement (mm)⁶
FNAV-DS-SM	14 F	6.0 MM	30 CM	107 CM	≥ 5.0 MM
FNAV-DS-LG	15 F	6.3 MM	30 CM	107 CM	≥ 5.5 MM

Navitor™ Loading System

Catalog Number
NVTR-LS-SM	The Navitor™ loading system facilitates valve preparation/loading onto the FlexNav™ delivery system. The loading system includes a loading funnel, loading base, base insert, loading tube, stent guide and leaflet tester. The LG loading system contains an extra base insert to facilitate loading of the 29 mm valve. All base inserts are labeled with the corresponding valve size. In addition, the base insert and loading tube are color-coded to differentiate between the different configurations.
NVTR-LS-LG

Catalog Number

NVTR-LS-SM

The Navitor™ loading system facilitates valve preparation/loading onto the FlexNav™ delivery system. The loading system includes a loading funnel, loading base, base insert, loading tube, stent guide and leaflet tester. The LG loading system contains an extra base insert to facilitate loading of the 29 mm valve. All base inserts are labeled with the corresponding valve size. In addition, the base insert and loading tube are color-coded to differentiate between the different configurations.

NVTR-LS-LG

* There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.
** 14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.
*** Until fully deployed.
^† Based on Echo Core Lab Data

References

Abbott data on file CL1014440.
Frater RWM, et al. Advances in anticalcific and antidegenerative treatment of heart valve bioprostheses. Silent Partners Inc. 1997;8:105-13.
Kelly SJ, et al. Biocompatibility and calcification of bioprosthetic heart valves. Society for biomaterials. Sixth World Biomaterials Congress Transaction. 2000;13534.
Vyavahare N, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation: efficacy and mechanisms. Circulation. 1997;95(2):479-88.
Vyavahare N, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation: mechanistic studies of protein structure and water-biomaterial relationships. J Biomed Mater Res. 1998;40(4):577-85.
Navitor™ TAVI System IFU.

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Navitor™ TAVI System

Transcatheter Aortic Valve Implantation (TAVI)