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On-X Ascending Aortic Prosthesis

with the Vascutek Gelweave Valsalva™ Graft1

The only valve/graft combination to offer:

  • A generous PTFE2 sewing ring for ease of suturing
  • The first coated valsalva graft for optimal coronary ostia reimplantation
  • Ongoing FDA IDE approved reduced anticoagulation clinical trial

AAP On X Ascending Aortic Prosthesis

Product Specifications

Valve Size Catalog Number Valve Internal Diameter (mm) Valve Orifice Area with Leaflets in Place (cm2) Sewing Ring Diameter3 (mm) Graft Diameter (mm) Graft Length (cm)
19 ONXAAP-19 17.4 2.00 27 20 11
21 ONXAAP-21 19.4 2.53 30 22 11
23 ONXAAP-23 21.4 3.13 33 24 11
25 ONXAAP-25 23.4 3.73 34 26 11
27/29 ONXAAP-27/29 23.4 3.73 36 26 11


Surgeon Quotes

“ . . . , the mechanical On-X valve exhibited improved hemodynamics, low TE and thrombosis rates, and low degrees of hemolysis, particularly in the aortic position.” Palatianos, et al.4

“ . . . , these data suggest that in a well-controlled population, anticoagulation at a lower level than that usually recommended would adequately mitigate thrombosis and thromboembolism, with a low incidence of anticoagulant hemorrhage. These data also confirm the excellent hemodynamics of the On-X valve . . . .” Williams, et al.5

“The advantage of using the On-X valve, however, may be its low propensity to thrombogenesis.5 Clinical trials looking at long-term outcomes in patients with the On-X valve receiving low levels of anticoagulation, including patients on aspirin and clopidogrel alone, are currently in progress.” Yezbick, et al.5,6

“ . . . . by using the new conduit [Vascutek Gelweave ValsalvaTM Graft] a valve motion more similar to that of the normal subject group was observed.” DePaulis, et al.7

“ . . . we preferred to use a Valsalva graft [Vascutek Gelweave ValsalvaTM Graft], as we believe it offers a better anatomical restoration of the aortic sinuses, producing a leaflet motion similar to that of normal subjects.” Pitsis, et al.8

References:

  1. The Vascutek Gelweave ValsalvaTM Graft is a product of Vascutek, a Terumo Company http://www.vascutek.com.
  2. On-X valve sewing rings are made of PTFE–polytetrafluoroethylene.
  3. Sewing ring nominal dimensions.
  4. Palatianos G, Laczkovics A, Simon P, et al. Multicentered European study on the safety and effectiveness of the On-X® Prosthetic Heart Valve: Intermediate follow-up. Ann Thorac Surg 2007;83:40-46
  5. Williams MA, van Riet S. The On-X heart valve — mid term results in a poorly anticoagulated population. J Heart Valve Dis 2006;15:80-86
  6. Yezbick AB, Ho JK, Crowley R, et al. Echocardiographic signature of the On-X valve. Echocardiography: J CV Ultrasound Allied Tech 2008;25(9):1016-18
  7. DePaulis R, De Matteis GM, Nardi P, et al. Analysis of valve motion after the reimplantation type of valve-sparing procedure (David I) with a new aortic root conduit. Ann Thorac Surg 2002;74:53-57
  8. Pitsis AA, Bougioukas IG, Kelpis TG, et al. Modified (valvsalva graft) aortic root reimplantation for successful repair of pulmonary autograft aneurysm after Ross procedure. Hellenic J Cardiol 2007;48:47-49



    9. The On-X® Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva™ Graft is FDA approved.
    CAUTION: Use of this device in the Prospective Randomized On-X Valve Anticoagulation Clinical Trial (PROACT) is limited by federal law to investigational sites. CAUTION: Federal law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use that accompany each valve for indications, contraindications, warnings, precautions and possible complications. For further information, visit www.onxlti.com.