INOVARE® SafeSync 5.5 Biological Valve Prosthesis
The INOVARE® SAFESYNC – B-Delivery System Biological Valve Prosthesis is indicated for the treatment of symptomatic patients with severe aortic valve stenosis (AS) who have a high predicted risk of mortality at 30 days, based on the Society of Thoracic Surgeons risk score (STS score), and other comorbidities not scored by the score, and are deemed appropriate for transcatheter aortic valve replacement (TAVR) treatment with transfemoral access.
Anvisa No.: 10159030114
Indication
- Treatment of symptomatic patients with severe aortic valve stenosis.
- Patients with moderate or high risk for conventional surgery.
- Implant performed via transfemoral approach in TAVR procedures.
Benefits and differentiators
- Minimal foreshortening (0.6 to 2.8 mm): greater predictability and precision in implantation.
- Optimized anatomical fit: prevents under or over-expansion at the aortic annulus.
- Leaflets produced from a single patch of bovine pericardium: fewer sutures and larger effective orifice area (EOA).
- Chromium-cobalt alloy structure: increased radial strength and reduced recoil.
- Large open cells: facilitate access to the coronary ostium.
- Outer casing in polyester (PET): efficient sealing and reduction of valve leakage.
- Radiopaque posts: allow precise commissural alignment.
