ST. PAUL, Minn.--(BUSINESS WIRE)--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced that the first patient implants occurred in the Portico™
Re-sheathable Transcatheter Aortic Valve System U.S. IDE Trial (PORTICO
trial). The trial is evaluating the Portico™
Transcatheter Aortic Valve System, the first aortic heart valve that
is repositionable until fully deployed. The trial will enroll patients
who are considered to have a high or an extreme surgical risk (meaning
they would not be considered) for open-heart surgery.
The Portico(TM) Transcatheter Aortic Heart Valve is being evaluated in a clinical study. Caution: Investigational device. Limited by Federal (or United States) law to investigational use. Photo provided by St. Jude Medical.
The PORTICO trial is evaluating the Portico valve and delivery system in
patients with symptomatic severe aortic stenosis – a narrowing of the
aortic valve that significantly impedes blood from flowing out of the
heart. During transcatheter aortic valve replacement (TAVR) procedures,
a Portico heart valve is delivered via a catheter using either a
transfemoral (through the artery in the leg) or an alternative access
approach in order to gain access to the heart. The Portico valve is
positioned in the patient’s heart as it continues to beat, alleviating
the need for cardiopulmonary bypass, where a machine takes over a
patient’s heart and lung function. Patients are evaluated by a heart
team consisting of a cardiac surgeon and an interventional cardiologist.
The first implants in the PORTICO trial were conducted the same day on
opposite coasts of the U.S. One operating team comprised of Dr. Raj
Makkar, director of Interventional Cardiology, and Dr.
cardiothoracic surgeon and program director of the Thoracic Surgery
Residency Program performed a Portico TAVR procedure at Cedars-Sinai
Heart Institute in Los Angeles. The other operating team was comprised
Gregory P. Fontana
, cardiac surgeon and chairman of the
department of cardiothoracic surgery and Dr.
interventional cardiologist at Lenox Hill Hospital in New York City.
Drs. Fontana and Makkar serve as co-principal investigators for the
“As we continue to collect clinical evidence on the best way to treat
patients identified as high or at extreme risk for the open-heart valve
replacement procedure, the Portico valve represents a life-saving
treatment option. The valve and delivery system were designed to more
safely treat heart failure symptoms in patients with stenotic valves,”
said Dr. Fontana.
“The ability to fully resheath and precisely reposition the Portico
valve at the implant site prior to valve deployment helps achieve
accurate placement, which may simplify the implant procedure and help
minimize procedural risk for the patient,” said Dr. Makkar.
St. Jude Medical incorporates more than 35 years of internally developed
valve experience into the design of the Portico valve. Built on the
successful Trifecta™ valve platform, the Portico valve is the
first transcatheter aortic valve that can be completely resheathed (the
process of bringing the valve back into the delivery catheter),
repositioned at the implant site, or retrieved before being released
from the delivery system.
“We have received positive feedback on the advanced features of the
Portico valve from the experienced physicians who have used it. The
Portico valve is an attractive option that will enable interventional
cardiologists and cardiac surgeons who perform TAVR procedures to treat
patients who might not otherwise be eligible for surgery,” said Dr.
, chief medical officer and vice president of global clinical
affairs at St. Jude Medical.
Designed in collaboration with physicians, the self-expanding Portico
valve is designed to maintain hemodynamics similar to that of a natural
valve, while also addressing issues from early generations of
transcatheter valves, such as paravalvular leak and the need for a
permanent pacemaker as a result of the implant.
A prospective, multi-center, randomized, controlled clinical trial, the
PORTICO trial is evaluating the safety and effectiveness of the Portico
Transcatheter Aortic Valve System in reducing the risk of death and
disabling stroke in patients with high or extreme surgical risk for
open-heart valve replacement surgery.
Patients at up to 40 U.S. sites will be randomized based on the
appropriate access method, including transfemoral, transapical (valve
delivered via the left ventricle of the heart), direct aortic (through
the ascending aorta), or subclavian (through an artery located below the
collar bone). All trial participants will undergo a TAVR procedure
receiving either a Portico valve or another commercially available TAVR
valve in the U.S. Data that are collected will be used to support
approval of the Portico Transcatheter Aortic Valve Replacement System by
the U.S. Food and Drug Administration (FDA).
In addition to randomization, the PORTICO trial will also collect
information in the form of a registry on patients with a degenerated
aortic surgical bioprosthetic valve (creating a valve-in-valve
registry.) These are patients in the trial who previously had valve
replacement surgery and now are having a Portico valve placed inside an
existing artificial valve without removing it.
mm Portico transcatheter aortic heart valve and transfemoral
delivery system received a CE Mark in 2012 and the 25
mm Portico valve received a CE Mark in 2013. CE Mark clinical trials
are currently underway for additional valve sizes and delivery
approaches. The Portico transcatheter aortic heart valve system is
limited to investigational use in the U.S., and the PORTICO trial is
being conducted under an Investigational Device Exemption (IDE) from the
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, the aortic heart valve becomes
calcified and does not open properly. Roughly 25 percent of people 65
and older, have aortic valve thickening and 3 percent age 75 and older
For additional information about the Portico valve visit SJMPortico.com
and for the PORTICO trial visit clinicaltrials.gov.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world’s most expensive,
epidemic diseases. The company does this by developing cost-effective
medical technologies that save and improve lives of patients around the
world. Headquartered in St. Paul, Minn., St. Jude Medical has four major
clinical focus areas that include cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com
or follow us on Twitter @SJM_Media.
This news release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve
risks and uncertainties. Such forward-looking statements include the
expectations, plans and prospects for the Company, including potential
clinical successes, anticipated regulatory approvals and future product
launches, and projected revenues, margins, earnings and market shares.
The statements made by the Company are based upon management’s current
expectations and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those described in
the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control and the
risk factors and other cautionary statements described in the Company’s
filings with the SEC, including those described in the Risk Factors and
Cautionary Statements sections of the Company’s Annual Report on Form
10-K for the fiscal year ended December 28, 2013 and Quarterly Report on
Form 10-Q for the fiscal quarter ended March 29, 2014. The Company does
not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
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Source: St. Jude Medical, Inc.