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Dafodil & Dafodil Neo Pericardial Bioprosthesis is Triple Composite biomechanically engineered valve. It combines the latest engineering advancements with the benefits of bovine pericardial tissue.

Why Dafodil Neo?

  • Dafodil Neo is a superior Bioprosthetic offering with unprecedented Hemodynamic advantages enabling an active lifestyle for patients
  • 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 * that is suited for narrow aortic annulus found in certain patients.
  • Bioprosthetic durability is of utmost priority and the Dafodil Neo Pericardial tissue and Elgiloy stent material are both known for their optimal intrinsic properties for aortic 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.
  • The Dafodil Neo represents a significant advancement in implant technology, offering notable improvements in implantability features. Its reduced profile and extension holder handle are specifically designed to enhance the ease of minimally invasive aortic valve replacement procedures.
  • 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.

Product Features

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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 ensure absolute uniformity, creating a triple-composite design. The frame, constructed with an Elgiloy alloy wireform, provides robustness through superior spring efficiency, as well as fatigue and corrosion resistance.

HEMODYNAMIC SUPPORT:

  • Triple-Composite design provides optimal Effective Orifce Area (EOA) and low pressure gradients The three separate leaflets are matched for better leaflet Coaptation which helps minimize Intra-Valvular Regurgitation

EASE OF IMPLANTABILITY:

  • Sewing ring is designed for better approximation to patient's annulus and for ease of implantability Commissural markers on sewing ring facilitates suture placement and valve orientation. Black sutures in Mitral valves helps reduce the profile of the commissures, easing the bioprosthesis implantation in the Mitral annulus Elgiloy alloy wireform provides excellent Radio-Opacity and handling characteristics.

Clinical Data

  • Dafodil 1 Study: A Prospective, single-arm, multi-centre study with a total 136 Subjects has been enrolled in this trial with 67 Aortic and 69 Mitral in a total of 19 Sites across India. The 3rd year data has been published in Frontiers in Cardiovascular Medicine. Currently the 5th year follow- up is ongoing.
  • Dictate Study: A Prospective, multi-center, single-arm, investigator-initiated study with a total of 150 patients in 3-4 centres in India is ongoing.
  • Dafodil PMCF Study: Retrospective, multi-center, observational, post-market clinical follow-up study with a total of 184 Patients in Approximately 7-10 centers in India is ongoing.