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Transcatheter Valve Replacement Portfolio

Portico™ Transcatheter Aortic Valve designed for implantation in the native aortic heart valve

Portfolio Overview

  • Offering catheter-based solutions to treat severe aortic stenosis†
  • Improving control and accuracy in valve positioning and placement1
  • Minimizing paravalvular leak (PVL) and potentially reducing the need for post-procedure pacemaker implantation1-8
  • Helping to minimize patient vessel trauma with the lowest-profile introducer.*,9

Innovative Transcatheter Technology

Our technological advances in transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR) technology make available innovative and life-saving treatment options for patients suffering from serve aortic stenosis who cannot undergo open-heart surgery or as an alternative to open-heart surgery. We offer a catheter-based heart-valve replacement solution designed to deliver exceptional hemodynamics (low gradients) and performance, as well as to enable greater control, accuracy and predictability.*,9



ADVANCED VALVE DESIGN

Our Portico™ transcatheter aortic valve system offers performance and optimal hemodynamics.1-8 

PRODUCTS IN THIS PORTFOLIO

3:12

Low-Profile Portico Solo™ Re-collapsible Introducer

See the Portico Solo™ re-collapsible introducer in action and how its low insertion profile may help reduce trauma in tortuous anatomy.


Smallest Insertion Profile*,9

The Portico Solo™ re-collapsible introducer has the smallest TAVI insertion profile (ID and OD)*,9 and is designed to reduce vessel trauma in tortuous anatomy.

  • Designed for precise trackability
  • Low-profile tip and folded pre-insertion profile enables smooth navigation
  • Low-friction hydrophilic coating for increased lubricity
  • Noncompliant radial expansion

Accuracy and Control

The Portico™ valve’s unique delivery system provides controlled deployment for greater accuracy and precise placement:

  • Fully repositionable** and retrievable** in situ
  • Gradual, controlled deployment and release across all valve sizes
  • Valve functioning during deployment to maintain hemodynamic stability
  • Flexible and trackable delivery system

Watch this animation to see how the Portico valve can be repositioned in situ** for optimal patient outcomes.1

Learn more about the Portico™ valve

3:18

Introducing the Portico™ Transcatheter Aortic Valve

See how the Portico™ valve can be repositioned in situ (until fully deployed).

Logo for Portico™ clinical program which studied 23 and 25 mm Portico aortic valves

Optimizing Patient Outcomes

Studies show that the Portico™ aortic valve has low rates of post-procedure pacemaker implantation and complications and comparable PVL when compared to second-generation transcatheter aortic valve implantation (TAVI) valves.1-8

Published clinical data on the 23 mm and 25 mm Portico valves demonstrate an excellent safety profile at 30 days. The program, which studied each valve size individually, showed:1

  • Low rates of death 
  • Low permanent pacemaker implantation rate
  • Low PVL
  • Low rates of stroke and major vascular complications
  • Exceptional hemodynamics sustained out to 12 months

A Leader in the Advancement of Structural Heart Disease Therapies

Many adults worldwide live with valvular disease and aortic stenosis, the world’s most common noncongenital valve disease.10 Because aging is a factor in aortic stenosis,10 it is expected to become even more prevalent as the population grows older. St. Jude Medical offers surgical and transcatheter** options for treating structural heart disease. We are focused on improving the lives of patients and offering physicians like you products designed for ease of use, with proven clinical outcomes.11,12

Learn more about our approach to structural heart disease.

Drawing of the heart that shows areas affected by structural heart defects

Resources and Documentation

REFERENCES

†Caution: investigational device (exclusively for clinical investigation) in select international markets. This therapy is not approved by the FDA for use in the United States. Limited by Federal (or United States) law to investigational use. Commercially available for use in select international markets.
* When used with the Portico™ delivery system.
**Until fully deployed.
1. Manoharan, G., & Portico, C. E. (2014, September). Trial Assessment of the St. Jude Medical Portico Transcatheter Aortic Valve Implant and the Transfemoral Delivery System. Presented at the meeting of Transcatheter Cardiovascular Therapeutics, Washington, D.C.
2. Popma, J. (2013, October-November). CoreValve US pivotal extreme risk iliofemoral study results. Presented at the meeting of Transcatheter Cardiovascular Therapeutics, San Francisco, CA.
3. Leon, M. B. (2013, March). A Randomized evaluation of the SAPIEN XT in patients with AS who are not candidates for surgery: PARTNER II, inoperable cohort. Presented at the meeting of the American College of Cardiology, San Francisco, CA.
4. Meredith, I. (2013, October-November). REPRISE II: A prospective registry study of transcatheter aortic valve replacement with a repositionable transcatheter heart valve in patients with severe aortic stenosis. Presented at the meeting of Transcatheter Cardiovascular Therapeutics, San Francisco, CA.
5. Shofer, J. (2013, October-November). Prospective, multicenter evaluation of the Direct Flow Medical transcatheter aortic valve: The DISCOVER trial 6-month follow-up. Presented at the meeting of Transcatheter Cardiovascular Therapeutics, San Francisco, CA.
6. Bavaria, J., Desai, N. D., Cheung, A., Petracek, M. R., Groh, M. A., Borger, M. A., & Schaff, H. V. (2014). The St Jude Medical Trifecta aortic pericardial valve: Results from a global, multicenter, prospective clinical study. The Journal of Thoracic and Cardiovascular Surgery, 47(2), 590-597. http://dx.doi.org/10.1016/j.jtcvs.2012.12.087
7. Leon, M. B., Smith, C. R., Mack, M., Miller, D. C., Moses, J. W., Svensson, L. G., … Pocock, S. (2010). Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. The New England Journal of Medicine, 363(17), 1597-1607. http://dx.doi.org/10.1056/NEJMoa1008232
8. Webb, J. (2014, May). 30-day outcomes from the SAPIEN 3 Trial, results for transfemoral cohort. Presented at EuroPCR, the meeting of the European Association of Percutaneous Interventions, Paris, France.
9. St. Jude Medical. Data on file, Report 90237740.
10. American Heart Association. Problem: Aortic valve stenosis http://www.heart.org/HEARTORG/Conditions/More/HeartValveProblemsandDisease/Problem-Aortic-Valve-Stenosis_UCM_450437_Article.jsp
11. Forbes, T. (2011, July). Interim results of the Amplatzer septal occluder post approval study. Presented at the meeting of the Pediatric and Adult Interventional Cardiac Symposium, Boston, MA.
12. Bavaria, J. E., Desai, N. D., Cheung, A., Petracek, M. R., Groh, M. A., Borger, M. A., & Schaff, H. V. (2014). The St. Jude Medical Trifecta aortic pericardial valve: Results from the global, multicenter, prospective clinical study. Journal of Thoracic and Cardiovascular Surgery, 147(2), 590-597. http://dx.doi.org/10.1016/j.jtcvs.2012.12.087

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