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TAVI

NAVITOR™ TAVI
CLINICAL DATA

Sustained hemodynamics, 0% moderate/severe PVL at 30 days, and a strong
5-yr durability signal

TAVI

NAVITOR™ TAVI
CLINICAL DATA

Sustained hemodynamics, 0% moderate/severe PVL at 30 days, and a strong 5-yr durability signal

Clinical Data

PROVEN CLINICAL EXCELLENCE
IN HEART VALVE REPLACEMENT

Navitor™ TAVI demonstrates excellent clinical trial results in transcatheter aortic valve implantation. Indicated for patients with severed aortic stenosis considered high-risk for surgery, Navitor TAVI represents a significant advancement in minimally invasive heart valve therapies.

Navitor IDE Study
5-year outcomes¹

Outcomes of the 5-year Navitor IDE study demonstrate strong clinical safety and sustained effectiveness through 5 years. Hemodynamic performance was excellent with low mean gradient of 6.5 mmHg and EOA of 2.0 cm²

Durability outcomes were highly favorable, with no hemodynamic structural valve deterioration, and exceptionally low rates of reintervention and valve-related mortality. Overall, these results underscore the reliable performance and continued clinical benefit of the Navitor™ Valve.

Hemodynamics Through 5 Years

Echo not performed at 3-year follow up; *Four- and five-year follow-up are still ongoing. Only 10 patients treated with a 35 mm valve are represented in the 4-year follow-up. No 35 mm valve patients have reached the 5-year follow-up window.

Conclusions

Navitor Valve

Favorable hemodynamic performance
through 5 years

100% of patients with mild or less PVL at 5 years
Single-digit MGs (6.5 mmHg) and large EOAs (2.0 cm²)
Consistent hemodynamic outcomes across all valve sizes

Valve durability through 5 years

No hemodynamic SVD (0%)
Low rates of NSVD (3.3%)
Low reintervention (0.6%) and valve-related death (0.3%)

Navitor IDE Study
30-day outcomes²

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MAT-2600879 v5.0 | Item approved for U.S. use only.

References

Kemp C. Five-Year Outcomes of Self-expanding Intra-annular Transcatheter Heart Valve in Patients with Severe Aortic Stenosis–An Update from the Navitor IDE Study. Presented at TCT 2026, October 31- November 3, 2026. San Diego, USA.
Reardon M, Chehab B, Smith D, et al. 30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study. J Am Coll Cardiol Intv. 2023 Mar, 16 (6) 681–689. doi.org/10.1016/j.jcin.2023.02.002.

Important Safety Information

Important Safety Information

Rx Only

NAVITOR™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM

INDICATIONS

The Navitor™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

CONTRAINDICATIONS

The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

POTENTIAL ADVERSE EVENTS

Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.