FLOMERO
Flomero Pericardial Bioprosthesis is a bovine pericardial, biomechanically engineered bioprosthesis featuring a triad frame design and triple composite leaflets mounted internally. Unique tissue fixation, state-of-the-art tissue thickness matching technology, advanced anti-calcification technology, and a mitral delivery system with a tenting facility translate into an efficacious product, enhancing Meril’s salient Tissue Heart Valve portfolio.
The triad frame comprises of a polymer ring (support ring), PET (polyethylene terephthalate) film structures (posts or commissures) and a frame made of Elgiloy alloy wireform. These three components of the frame are covered with polyester fabric and the frame is designed to be compliant at the orifice and commissures. A sewing ring made from polyester fabric is attached to the covered frame, featuring three contrasting markings to aid in the proper orientation for the implantation of the prosthesis.
Advantages and Properties
Trusted durability
- Leaflets are treated with a proprietary anti-calcification process to increase the valve's long-term durability.
- Three independent pericardial leaflets are laser cut to provide absolute uniformity realizing a Triple-composite design.
- The triad-frame design with the elgiloy alloy wireform provides Robustness via Superior spring efficiency, fatigue, and corrosion resistance.
Hemodynamics Support
- Triple Composite Design provides optimal Effective Orifice Area (EOA).
- The three separate leaflets are matched for better leaflet Coaptation, which helps minimize Intra-Valvular Regurgitation.
Ease of Implantibility
- Available with Active Flex Technology—Black Sutures in Mitral valves help reduce the profile of the commissures and ease the bioprosthesis implantation in the Mitral annulus.
- Sewing ring designed for better approximation of the patient's annulus and for ease of implantability.
- Commisural marker on the sewing ring facilitates suture placement and valve orientation.
- Elgiloy alloy wireform provides excellent radio-opacity and handling characteristics.
Clinical Data
Product IFU
Note: IFU will be displayed after MDR Certification