Feature | January 02, 2014

St. Jude Medical Gains CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve

st. jude portico transcatheter aortic heart valve repair hybrid or
January 2, 2014 — St. Jude Medical Inc. received European CE mark approval for its 25 mm Portico Transcatheter Aortic Heart Valve Implantation System. The approval expands the number of patients who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR) procedures.
 
“The fact that the Portico valve is repositionable prior to valve deployment helps ensure accurate placement, potentially improving patient outcomes,” said Axel Linke, M.D., University of Leipzig, Germany, and investigator in the Portico Transfemoral CE Mark Trial (Portico TF CE Trial).
 
Made of bovine pericardial tissue attached to a self-expanding stent frame, the Portico valve is the first transcatheter aortic heart valve that can be completely resheathed, repositioned at the implant site or retrieved before being released from the delivery system.
 
“The Portico valve is an important part of our growing portfolio of products that treat valvular disease and heart failure. The approval of this 25 mm valve size will allow us to expand our footprint in the global TAVR market and provide a promising solution for patients with severe aortic stenosis,” said Frank Callaghan, president, cardiovascular and ablation technologies division, St. Jude.
 
The 25-mm Portico valve supports a patient’s native annulus with diameters ranging from 21 to 23 mm. With the addition of the 25 mm valve, the Portico platform can now treat patients with an annulus ranging from 19 to 23 mm. In 2014, St. Jude Medical expects to add two additional valve sizes to the Portico line, which will expand the eligible range of patients to those with annulus sizes ranging from 19 to 27 mm.
 
During an implant procedure, the Portico valve is delivered through a catheter after a small incision is made to the femoral artery in the leg. Positioned while the patient’s heart continues to beat, use of the Portico valve alleviates the use cardiopulmonary bypass.
 
The Portico 23- and 25-mm transcatheter aortic heart valves continue to be evaluated in a non-randomized, multicenter study, the Portico TF CE Trial. Data from this study was recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Results highlighted the valves’ hemodynamic performance and improvement in the severity of patients’ heart failure symptoms as measured by the New York Heart Association (NYHA) Functional Classification System. The 23 mm Portico Transcatheter Aortic Heart Valve received CE mark November 2012. The Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System are not approved for use in the United States.
 
For more information: www.sjmportico.com

Related Content

Lotus Edge valve
News | Heart Valve Technology| December 07, 2016
December 7, 2016 — Boston Scientific announced a definitive agreement to acquire certain manufacturing assets and cap
TCT 2016, TCT.16, main arena, late breaking trials, transcatheter cardiovascular therapeutics

There were several hot topics that came out of the 2016 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting Oct. 29 - Nov. 2, which made this month's top 20 list, including several videos. Number 4 on the list of content was the result of the EXCEL Trial key TCT late-breaker, which showed stenting is equal in outcomes to surgery for the first time, when using one of the latest generation drug-eluting stents. 

Feature | December 05, 2016
December 5, 2016 — Here is the list of the top 20 most popular pieces of content on the Diagnostic and Interventional
Cardioband, valtech, Edwards Lifesciences, transcatheter mitral repair, transcatheter tricuspid valve repair, transcatheter annuloplasty

An illustration of how the transcatheter Cardioband System can used as a non-surgical form on annuloplasty repair. 

News | Heart Valve Technology| December 02, 2016
December 2, 2016 — Edwards Lifesciences Corp.
Mitralign, Trialign System, tricuspid regurgitation, first transcatheter repair, cardiac implantable device lead, Piedmont
News | Heart Valve Technology| November 18, 2016
Mitralign Inc. announced the successful compassionate use treatment of a patient suffering from tricuspid regurgitation...
Sponsored Content | Videos | TCT| November 18, 2016
DAIC Editor Dave Fornell takes a video tour of some of the most innovative new interventional cardiology technologies
Sponsored Content | Videos | Heart Valve Technology| November 18, 2016
A discussion with Torsten Vahl, M.D., about advancements in transcatheter valve repair technology, including new devi
Sponsored Content | Videos | Heart Valve Technology| November 18, 2016
A discussion with Juan Granada, M.D., about transcatheter mitral valve advancements and device challenges at the Tran
Barco, Nexxis OR imaging management platform, 1,000 installations worldwide, RSNA 2016
News | Flat Panel Displays| November 11, 2016
Barco recently announced that Nexxis, its IP-based OR imaging management platform, is now operating in over 1,000...
Greenbaum, Henry Ford Hospital, LAMPOON procedure, mitral valve
News | Heart Valve Technology| November 10, 2016
November 10, 2016 — A Henry Ford Hospital cardiologist is pioneering a promising new procedure to improve the success
NeoChord, RECHORD Trial, first patient, DS1000 System, degenerative mitral regurgitation, DMR
News | Heart Valve Technology| November 10, 2016
NeoChord Inc. announced the first use of its DS1000 System in the United States as it enrolled the first patient in the...
Overlay Init