Transcatheter Aortic Valve Implantation (TAVI) with the Navitor™ TAVI System provides an alternative, minimally invasive treatment option for people living with severe aortic stenosis, a condition where the aortic valve does not fully open or close, who are not candidates for open-heart surgery due to age, frailty, or other conditions that ...

The VANTAGE clinical trial will evaluate the safety and effectiveness of the Navitor valve in patients with severe, symptomatic aortic stenosis who are at intermediate or low risk of surgical mortality.

2023年5月1日 · The primary objective of the clinical study is to evaluate the acute safety and effectiveness of the Navitor Transcatheter Aortic Heart Valve based on the rates of all-cause mortality at 30 days and moderate or greater paravalvular leak at 30 days .

Navitor TAVI System clinical trial results demonstrate excellent outcomes across a spectrum of routine to challenging anatomies for aortic valve stenosis.

The purpose of this research study is to expand the indication of the Navitor TAVI System to patients at intermediate and low risk for open heart surgery.

2023年6月27日 · Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement

The VANTAGE clinical trial will test how safe and effective the Navitor valve is for patients who have severe, symptomatic aortic stenosis and are at low to moderate risk of complications from surgery. The trial will also look at how safe and effective the Navitor valve is when used in a valve-in-valve procedure.

The objective of ENVISION is to evaluate the safety and effectiveness of the NavitorTM Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.

The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to supp...

2019年7月4日 · The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to ...