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No-React® Versaflex Aortic Valve

• Clinical applicability of a stented valve
• Haemodynamics of a stentless valves while avoiding distortion of cusp coaptation
• Special techniques and instruments are not required
• Pledgeted commissures distribute stresses of valve closure
• Flexibility allows for less reliance on the shape of the annulus
• Valve can be oversized to obtain best haemodynamics
• Clinical records of significant increase in EOA and reduction in left ventricular mass

The BioIntegral Surgical No-React ® treated Versaflex ™ valve was designed  for ultimate versatility. Its wide clinical  applicability is equal to a stented valve,  while it delivers the hemodynamics of a  stentless valve. The Versaflex does not  require special techniques or instruments,  and no pre-operative rinsing is required.  The Versaflex has a “skeletonised” plastic  stent. The advantage of the skeleton is that  the valve is ultra-flexible, easy to implant,  and most importantly, the ring of the  skeleton assures the cusps are on the  same level and any pathological aorta  cannot disturb the intended coaptation. For  that reason, in 12-years and 20,000  implants, central regurgitation has never  been reported.  Super flexible stent allows for less reliance on  the shape of the annulus for proper fit. Even if  distorted wider by 2 -3 sizes the valve can still  coapt  Aortic Root asymmetry has no influence on  result. The Versaflex gives very good  haemodynamics and favourable outcomes,  including significant increase in EOA.  Valves have tested positive for endothelial  coverage and have been used to avoid  reinfection in cases of infective endocarditis.Benefits

• Significant increase in EOA and reduction in left ventricular mass
• Even if distorted wider by 2 -3 sizes the valve can still coapt
• Clinical applicability of a stented valve but with better EOA
• Easy to implant



No-React® Injectable Pulmonic Valve – designed for use Off Pump


· Large-diameter trocar implantation; no bypass necessary

· Low Profile

· No Distal or Proximal Suture Lines

· No Coronary Compression

· Enables Primary or Secondary Repair of Tetralogy of Fallot

· A full range of sizes from 15 - 31 mm is available to match patient morphology

· No reported structural failures or stent fracture over 9 years

· 9 years’ experience -  longest of any transapical heart valve






Patients born with Tetralogy of Fallot or other forms of pulmonary valve malfunction will require early surgical intervention. Later in life they will need pulmonary valve replacement with either a homograft or a tissue valve. However standard glutaraldehyde treated tissue has limited durability and is prone to infection, rejection, adhesions, calcification and thrombosis, requiring repeat operations in the future.


The No-React® Injectable Pulmonic Valve (NRIP) is the only device on the market that offers the combination of a highly durable, infection, calcification and dilatation resistant tissue valve with an implantation system that avoids the risks associated with repeated cardiopulmonary bypass (CPB) supported operations.


The potential benefits of the NRIP for Secondary Repair  include :


  • Faster recovery and a lower risk of post-operative morbidity

  • Shorter operating times

  • Cost savings – theatre costs are lower, no CPB consumables,post-operative care  is reduced (shorter duration of ventilation, intensive care and overall hospital stay; fewer blood products; fewer resources to treat comorbidity).

  • Fewer operations required in the future for the patient owing to greater longevity of the No-React® NRIP device than standard glutaraldehyde treated devices




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