DAFODIL NEO
- Dafodil Neo Pericardial Bioprosthesis is a Triple Composite biomechanically engineered valve. It combines the latest engineering advancements over the Dafodil valve along with the benefits of bovine pericardial tissue.
- Dafodil Neo comes with certain enhancements in implantability (reduced profile and an extension holder handle) suitable for minimally invasive valve replacement.
- A reduction in the sewing ring diameter ensures better utilisation of the patient annulus area that ultimately translates into better hemodynamics for the patient.
- Dafodil Neo Aortic valve comes with a unique 17mm size offering (by prescription only) that is suited for narrow aortic annulus found in certain patients.
- Pericardial tissue and Elgiloy stent material are both known for their optimal intrinsic properties for valve manufacture.
- Integrated processes such as Unique Tissue fixation, Advanced Tissue Thickness Matching Technology for Uniformity, and Tissue Deflection Testing enable leaflets to be accurately matched.
- Position-specific design answers the challenging requirements of the mitral & aortic position Unique Delivery System For Mitral Position with the new Active flex technology that helps in reducing the external stent post diameter to aid in valve placement in the mitral position.
Advantages and Properties
Trusted durability
Properties
- Three leaflets are independently laser cut to provide precision and uniformity in size and shape for better haemodynamics and durability.
- Triad-frame design with elgiloy alloy wireform provides Robustness via Superior spring efficiency, Fatigue and Corrosion resistance.
- Leaflets are treated with proprietary anti Calcification treatment to increase the valve’s long term durability.
- In-vitro testing: 200 M cycles proven in-vitro durability as per ISO 5840.
- Protected by Anti Ca+ anticalcification treatment that helps in removing aldehydes and phospholipids.
Ease of Implantability
Properties
Aortic
- New 17mm size offering suited for small aortic annulus (custom made device on prescription basis only).
- Commissural markers on sewing ring facilitates suture placement and valve orientation.
Mitral
- Reduced mitral protrusion to provide greater ease of implantability.
- Locking threads and Rotator are additional components in the construction of the Mitral valve.
- Polyester Black sutures in Mitral valves helps reduce the profile of the commissures, easing the bio-prosthesis implantation in the Mitral annulus.
- Separate long holder handle is provided, making it suitable for minimally invasive procedures.
Hemodynamics
Properties
- The pericardial leaflets are matched in all aspects (triple composite design) to ensure optimal coaptation that helps in minimising valve regurgitation.
- Dafodil Neo comes with a reduction in the stent diameter to tissue annulus diameter ratio that translates in superior hemodynamics for a given patient annulus.
Indication
An Aortic Dafodil Neo™ Pericardial Bioprosthesis is indicated for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis which is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.
Product Specifications
Available Bioprosthesis Diameter(mm) |
Ordering Information | |
---|---|---|
Aortic Model | Mitral Model | |
17 |
DDLN17A *17 mm valve is avilable as a "Custom made device" on prescription only |
N/A |
19 | DDLN19A | N/A |
21 | DDLN21A | N/A |
23 | DDLN23A | DDLN23M |
25 | DDLN25A | DDLN25M |
27 | DDLN27A | DDLN27M |
29 | DDLN29A | DDLN29M |
31 | N/A | DDLN31M |
33 | N/A | DDLN33M |
Size Chart
Meril Dafodil Neo Aortic Valve | 17mm | 19mm | 21mm | 23mm | 25mm | 27mm | 29mm |
A. Tissue Annulus Diameter | 17 | 19 | 21 | 23 | 25 | 27 | 29 |
B. Internal Stent Post Diameter(Base) | 16 | 18 | 20 | 22 | 24 | 26 | 28 |
C. External Sewing Ring Diameter | 23 | 25 | 27 | 29 | 31 | 33 | 35 |
D. Total Profile Height | 14 | 14 | 15 | 16 | 17 | 18 | 18 |
Meril Dafodil Neo Mitral Valve | 23mm | 25mm | 27mm | 29mm | 31mm | 33mm |
A. Stent Diameter(Wire Form) | 23 | 25 | 27 | 29 | 31 | 33 |
B. External Stent Post Diameter(Base) | 26.5 | 28.5 | 30.5 | 33 | 35 | 37 |
C. External Stent Post Diameter(Tip) | 27 | 29 | 31 | 33.5 | 35.5 | 35.5 |
D. External Sewing Ring Diameter | 33 | 36 | 38 | 41 | 43 | 45 |
E. Ventricular Protrusion | 9 | 10 | 11 | 12 | 12 | 12 |
F. Total Profile Height | 15 | 16 | 17 | 18 | 18 | 19 |
Clinical Data
Product IFU
Note: IFU will be displayed after MDR Certification