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Mitroflow with PRT

Catalogue: Outside USA

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HIGH PERFORMANCE AORTIC PERICARDIAL HEART VALVE

MITROFLOW WITH PRT offers excellent hemodynamic performance, ease and versatility of implant, and excellent long-term outcomes. 

 

Excellent Hemodynamic Performance
•  Maximized flow area
•  Wide opening
•  Synchronous leaflet action
•  Uniform mechanical behavior
•  Optimized hemodynamic performance
 
Ease and Versatility of Implant
•  Small, streamlined sewing ring
•  Low valve profile
•  Valve versatility
 
Proven Clinical Results
•  Unique design since 1982
•  Excellent long-term clinical outcomes
 
PRT Treatment
•  PRT is aimed at mitigating calcification and further 
    improvement of its exceptional performance

 

IM-00519A

 

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Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For indications, contraindications, precautions and warnings for each device, please refer to the Instructions For Use.

Features

EASE AND VERSATILITY OF IMPLANT

 

Soft, streamlined sewing cuff
•  Easy to suture
•  Conforms to the native annulus
•  Adapts to difficult anatomies, especially in small annuli
•  Radiopaque due to tungsten impregnated sewing ring

 

Low valve profile
•  Coronary ostia clearance
•  Reduced risk of interference with the
    Sino-Tubular Junction in narrow aortic roots
•  Suitable for either supra-annular or intra-annular positioning
•  Aids visibility of aortic anatomy

TREATED TO LAST

 

Phospholipid reduction treatment (PRT) for mitigated calcium absorption

The presence of phospholipids in the pericardial tissue play a key role in the calcification process of bioprostheses, as their phosphate heads are potential binding sites for circulating calcium ions.

Mitroflow with PRT features Sorin’s patented Phospholipid Reduction Treatment (PRT) which has proven to decrease phospholipid content in pericardial tissue, leading to a remarkable reduction of calcium uptake compared to control tissue.*

The PRT process removes phospholipids using Octanediol, a long chain alcohol that possesses a lipid-soluble tail to aid its solubility in phospholipids's heads and a water-soluble head to allow removal by rinsing pericardial layers before valve manufacturing.

* Herijgers et al. - Anticalcification Treatments of Bioprosthetic Pericardial Heart Valve Tissue: a Comparative Experimental Study. ESCVC 2015, Istanbul.

 

Evidence

THE ITALIAN STUDY ON THE MITROFLOW POSTOPERATIVE RESULTS (ISTHMUS): A 20-YEAR, MULTICENTRE EVALUATION OF MITROFLOW PERICARDIAL BIOPROSTHESIS

 

ISTHMUS Investigators - Eur J Cardiothorac Surg, 2011. 39(1): p. 18-26; discussion 26.

 

Patient Characteristics

 

Hemodynamic Results

 

“Complete echocardiographic assessment, pre- and post-operatively, was available in 1031 patients. Favourable hemodynamic performance was observed in the vast majority of patients, also in the presence of small prosthetic sizes.”

“Our echocardiographic findings at discharge and at follow-up, obtained at rest, were consistent with satisfactory hemodynamic properties of the Mitroflow pericardial valve, particularly in small sizes, and confirmed excellent and constant hemodynamic performances in the majority of the patients also at long term.

 

Clinical Results

“In our series, there was a low incidence of SVD, with only 3.7% of implanted valve replaced during a 20-year follow-up”

“Our findings were also consistent with the more favourable outcome in patients older than 70 years of age as shown by all published Mitroflow series. In our experience, atherosclerotic degeneration largely represented the predominant mode ofbioprosthetic failure.”

”Non-structural valve deterioration rate in our series was also low (0.5 patient/year), and mainly related to technical failure or to paravalvular leak.”

 

 

 

 

 

Conclusion

“This study indicates that the Mitroflow pericardial valve provides favourable postoperative results at long term in terms of valve durability, valve-related events and patient clinical conditions. Furthermore, good hemodynamic performance can be expected postoperatively, even in the presence of small prosthetic sizes, therefore representing, in our opinion, an extremely valuable bioprosthesis in case of planned aortic valve replacement with a tissue valve, particularly for patients older than 70 years or in the presence of a small aortic annulus.

 

ISOLATED AORTIC VALVE REPLACEMENT IN PATIENTS WITH SMALL AORTIC ANNULUS-A HIGH-RISK GROUPON LONG-TERM FOLLOW-UP.

 

Wilbring M. et al. - Thorac Cardiovasc Surg, 2013. 61(5): p. 379-85. 

 

Patient Characteristics​

 

Hemodynamic Results

 

Conclusion

“We observed excellent reduction and stability of transvalvular pressure gradients and could also observe an excellent durability of the valves. During the whole follow-up, which ranged up to 11 years, we recorded no reoperation because of failed prosthesis. In the present series the use of the Mitroflow valve, with its large orifice area, reduced incidence of PPM to 12.2%.” 

“Patients with small aortic annulus needing isolated aortic valve implantation form a high-risk subgroup and are often represented by small, obese, and old-aged females with a broad spectrum of comorbidities and associated high surgical risk.”

“The Mitroflow valve with its large orifice area can help to reduce the incidence of PPM and thus help to avoid extended and risky root-enlarging surgery.”

AORTIC VALVE REPLACEMENT WITH THE MITROFLOW PERICARDIAL BIOPROSTHESIS: DURABILITY RESULTS UP TO 21 YEARS.

 

Yankah C.A. et al. - J Thorac Cardiovasc Surg, 2008. 136(3): p. 688-96

 

Patient Characteristics

 

Hemodynamic Results

 

Clinical Results

 

 

 

 

 

 

 

 

 

Conclusion

“The Mitroflow pericardial bioprosthesis exhibits very low pressure gradients combined with easy implantability. After two decades of follow-up, the Mitroflow pericardial aortic valve continues to be a valve of choice with a predictable low rate of valve-related events, particularly for patients over the age of 65 -70 and others with comorbidities.”

ANTICALCIFICATION TREATMENTS OF BIOPROSTHETIC PERICARDIAL HEART VALVE TISSUE: A COMPARATIVE EXPERIMENTAL STUDY

Herijgers et al. - ESCVC 2015, Istanbul.

 

By reducing the nucleation sites for calcium deposition - the phospholipids in the pericardial tissue - the Phospholipid Reduction Treatment (PRT) directly addresses the origin of tissue calcification, which may lead to an enhanced valve durability. Tests in subcutaneous rat implants at 60 days demonstrate a significant reduction of calcium content in PRT-treated bovine pericardium patches compared to control.

 

 

 

Conclusion

“The Phospholipid Reduction Treatment (PRT) process is intended to enhance already proven resilient durability by reducing calcium absorption up to 97% compared to control.” 

BIBLIOGRAPHY

 

  1. ISTHMUS Investigators - The Italian study on the Mitroflow postoperative results (ISTHMUS): a 20-year, multicentre evaluation of Mitroflow pericardial bioprosthesis. - Eur J Cardiothorac Surg, 2011. 39(1): p. 18-26; discussion 26. Click here

  2. Wilbring M. et al. - Isolated aortic valve replacement in patients with small aortic annulus-a high-risk group on long-term follow-up. - Thorac Cardiovasc Surg, 2013. 61(5): p. 379-85. Click here

  3. Yankah C.A. et al. - Aortic valve replacement with the Mitroflow pericardial bioprosthesis: durability results up to 21 years. - J Thorac Cardiovasc Surg, 2008. 136(3): p. 688-96. Click here

  4. Herijgers et al. - Anticalcification Treatments of Bioprosthetic Pericardial Heart Valve Tissue: a Comparative Experimental Study. - ESCVC 2015, Istanbul. Click here

  5. Asch F.M. et al. - Mitroflow aortic bioprosthesis 5-year follow-up: North American prospective multicenter study. - Ann Thorac Surg, 2012. 94(4): p. 1198-203. Click here

  6. Conte J. et al. - A North American, prospective, multicenter assessment of the Mitroflow aortic pericardial prosthesis. - Ann Thorac Surg, 2010. 90(1): p. 144-152.e1-3. Click here

  7. Jamieson W.R. et. al. - Mitroflow aortic pericardial bioprosthesis--clinical performance. - Eur J Cardiothorac Surg. 2009 Nov;36(5):818-24. doi: 10.1016/j.ejcts.2009.05.020. Epub 2009 Aug 22. Click here

  8. Joshi V. et al. - Early prosthetic valve degeneration with Mitroflow aortic valves: determination of incidence and risk factors. - Interact Cardiovasc Thorac Surg, 2014. 19(1): p. 36-40. Click here

  9. Sjogren J. et al. - Long-term outcome of the MitroFlow pericardial bioprosthesis in the elderly after aortic valve replacement. - J Heart Valve Dis, 2006. 15(2): p. 197-202. Click here

  10. Pettenazzo E. et al. - Octanediol treatment of glutalaldehyde fixed bovine pericardium: evidence of anticalcification efficacy in the subcutaneous rat model. - Eur J Cardiothorac Surg. 2008 Aug;34(2):418-22. Epub 2008 Jun 11.

  11. Pathak C.P. et al. - Treatment of bioprosthetic heart valve tissue with long chain alcohol solution to lower calcification potential - J Biomed Mater Res A. 2004 Apr 1;69(1):140-4.

 

 

Download Area

  • Sorin Magnetic Resonance Document (M-00000 F) download 694.05 kB application/pdf

This product may not be for sale in your country or your area. For further information on product availability, please contact your local representative

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