BioIntegral Valves

BioIntegral Surgical

BioIntegral Surgical manufactures cardiac and vascular implants made from all-biological materials, using the No-React® treatment. No-React® is a proprietary detoxification of glutaraldehyde-treated tissue.

BioIntegral Surgical manufactures and sells products for mitral, aortic, and pulmonic valve replacement and repair, as well as repair patches.

The total products set covers mitral valve repair (beyond commodity rings), minimally-invasive valve replacement, a full pediatric product line, all-biological mitral and aortic valves including totally biologic aortic valved conduits, and a full size range of pericardial patches.

BIOCONDUIT™ – the first and only all-biological valved aortic conduit

• Reinfection rates as low as homografts

• No long-term anticoagulation needed in any population

• Available in a variety of sizes to prevent mismatch

• Resists tissue “remodeling” that can lead to dilatation in the Ross procedure

• Zero porosity: one layer of bovine pericardium

• Excellent hemodynamics and easy to implant

• Can be oversized to maximize flow

BIOMITRAL™ I BIOAORTIC™ – All-Biological stented porcine mitral valves

• First replacement valves which avoid use of fabric materials

• Do not require special techniques or instruments

• 15 years of clinical use without any report of stent fracture or tissue failure

• Reinfection rates similar to that of homografts

• Lowest endocarditis reinfection rate of any off-the-shelf solution

• Tested positive for endothelial coverage

BIOPULMONIC™ CONDUIT

• CE marked as of March 2015

• Lowest all-event rate of any conduit, of any type – including the homografts

INJECTABLE BIOPULMONIC™ - All-Biologic off-pump injectable porcine pulmonic valve

• Percutaneous, large diameter injectable valve implanted without cardio-pulmonary bypass

• Available in all range of sizes, from 15 – 31 mm

• With external fixation to prevent migration

• No stent fractures reported

• 8 years of experience

VERSAFLEX™ – Ultra flexible, stented porcine aortic valve

• Designed for ultimate versatility

• Wide clinical application equal to stented valves, while it delivers hemodynamics of a stentless valve

• Doesn’t require special techniques or instruments

• Pledgeted commissures distribute stress of valve closure

• Flexible stent delivers good hemodynamics, but avoids distortion common to stentless valves

• Oversizing possible with full benefits

• Clinically associated with significant increase of EOA and reduction in left ventricular mass

• Over 15 years of clinical use and follow-up, no reports of stent fracture or tissue failure

•Clinically used and proven to avoid reinfection in cases of infective endocarditis

More than 20 years of proven clinical experience with No-React® devices shows:

• Reduced toxicity

• Enhanced biocompatibility

• Dramatically lower rates of infection

• Elimination of adhesion and calcification

• Promotion of functional endothelial lining