News | Heart Valve Technology | June 17, 2015

FDA Approves Resumption of St. Jude Medical Portico IDE Trial

Medical review finds no clinical events associated with reduced leaflet motion observed in some patients

Portico, St. Jude Medical, FDA, U.S. evaluation, resume

June 17, 2015 - St. Jude Medical Inc. announced the resumption of the company's U.S. investigational device exemption (IDE) trial evaluating the Portico transcatheter aortic valve implantation system. The Portico IDE trial originally launched in May 2014, and is designed to support U.S. approval of the Portico system.

The approval follows a comprehensive review of the Portico system by the U.S. Food and Drug Administration (FDA) after St. Jude Medical temporarily paused implants of the valve worldwide in September 2014. The company decided to pause implants due to reports of reduced leaflet motion observations in patients implanted with Portico within the IDE study. The observation was subsequently identified in the study's control arm, which consisted of commercially-available TAVR valves.

St. Jude Medical's review found no excess rate of clinical events associated with the leaflet motion observation. The company's findings were then confirmed by independent reviews, which found reduced leaflet mobility is a class effect, present in TAVR and surgical valves across the industry. The data also confirmed that the observation is not linked to excess adverse clinical events, has not been shown to impact valve clinical performance and can be resolved by medical therapy.

Aortic stenosis is the third most prevalent form of cardiovascular disease in the western world after hypertension and coronary artery disease. Considered a potentially life-threatening condition, in patients suffering from severe aortic stenosis the aortic heart valve becomes calcified and does not open properly. TAVR procedures offer physicians an additional treatment option for patients who are considered too high of a risk to undergo open heart surgery.

The Portico system was developed to simplify TAVR procedures for physicians by improving control, ease of use and accuracy over other commercially-available TAVR valves. The system also offers the ability to be fully recaptured and repositioned prior to full deployment and release from the delivery system, allowing physicians to obtain optimal placement to improve patient outcomes.

"I'm very proud to work alongside a team of investigators that partnered with St. Jude Medical to prioritize patient safety and support the industry's current understanding of leaflet motion observations relative to transcatheter and surgical valves," said Raj Makkar, M.D., director of interventional cardiology at Cedars-Sinai Heart Institute in Los Angeles and a co-principal investigator for the Portico U.S. IDE. "I'm excited to be able to resume our IDE study and advance the evaluation of the Portico valve in the U.S."

For more information:

Related Content

Edwards Lifesciences Centera self expanding transcatheter (TAVR) valve has been approved with CE mark for use in Europe.
Feature | Heart Valve Technology | February 15, 2018
February 15, 2018 — Edwards Lifesciences Corp.
Boston Scientific Enters Investment and Acquisition Option Agreement With Millipede
News | Heart Valve Technology | January 24, 2018
Boston Scientific Corp. announced it has closed an investment and entered into an acquisition option agreement with...
Edwards LifeSciences Recalls Sapien 3 Certitude Delivery System
News | Heart Valve Technology | January 11, 2018
The U.S. Food and Drug Administration (FDA) announced that Edwards LifeSciences is recalling its Certitude Delivery...
Videos | Heart Valve Technology | January 04, 2018
Adam Greenbaum, M.D., co-director, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, explains how hi
Edwards Acquires Harpoon Medical
News | Heart Valve Technology | December 07, 2017
December 7, 2017 — Edwards Lifesciences Corp.
Videos | Heart Valve Technology | November 15, 2017
Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, is the principal investigato
New Analyses Reinforce Hemodynamic Benefits of Evolut TAVR Platform in Intermediate-Risk Aortic Stenosis Patients
News | Heart Valve Technology | November 08, 2017
Medtronic plc recently presented new clinical research to support the positive clinical performance of the Evolut...
Videos | Heart Valve Technology | November 08, 2017
Philippe Genereux, M.D., co-director of the structural heart program at the Gagnon Cardiovascular Institute at Morris
Videos | Heart Valve Technology | November 08, 2017
Stephen Worthley, MB, BS, Ph.D., director of cardiac catheterization, University of Adelaide, Australia, presents the
Overlay Init