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 (PORTICOtrial). The trial is evaluating the Portico^™Transcatheter Aortic Valve System, the first aortic heart valve thatis repositionable until fully deployed. The trial will enroll patientswho are considered to have a high or an extreme surgical risk (meaningthey 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 inpatients with symptomatic severe aortic stenosis – a narrowing of theaortic valve that significantly impedes blood from flowing out of theheart. During transcatheter aortic valve replacement (TAVR) procedures,a Portico heart valve is delivered via a catheter using either atransfemoral (through the artery in the leg) or an alternative accessapproach in order to gain access to the heart. The Portico valve ispositioned in the patient’s heart as it continues to beat, alleviatingthe need for cardiopulmonary bypass, where a machine takes over apatient’s heart and lung function. Patients are evaluated by a heartteam consisting of a cardiac surgeon and an interventional cardiologist.

The first implants in the PORTICO trial were conducted the same day onopposite coasts of the U.S. One operating team comprised of Dr. RajMakkar, director of Interventional Cardiology, and Dr.Wen Cheng,cardiothoracic surgeon and program director of the Thoracic SurgeryResidency Program performed a Portico TAVR procedure at Cedars-SinaiHeart Institute in Los Angeles. The other operating team was comprisedof Dr.Gregory P. Fontana, cardiac surgeon and chairman of thedepartment of cardiothoracic surgery and Dr.Carlos Ruiz, aninterventional cardiologist at Lenox Hill Hospital in New York City.Drs. Fontana and Makkar serve as co-principal investigators for thePORTICO trial.

“As we continue to collect clinical evidence on the best way to treatpatients identified as high or at extreme risk for the open-heart valvereplacement procedure, the Portico valve represents a life-savingtreatment option. The valve and delivery system were designed to moresafely treat heart failure symptoms in patients with stenotic valves,”said Dr. Fontana.

“The ability to fully resheath and precisely reposition the Porticovalve at the implant site prior to valve deployment helps achieveaccurate placement, which may simplify the implant procedure and helpminimize procedural risk for the patient,” said Dr. Makkar.

St. Jude Medical incorporates more than 35 years of internally developedvalve experience into the design of the Portico valve. Built on thesuccessful Trifecta^™ valve platform, the Portico valve is thefirst transcatheter aortic valve that can be completely resheathed (theprocess of bringing the valve back into the delivery catheter),repositioned at the implant site, or retrieved before being releasedfrom the delivery system.

“We have received positive feedback on the advanced features of thePortico valve from the experienced physicians who have used it. ThePortico valve is an attractive option that will enable interventionalcardiologists and cardiac surgeons who perform TAVR procedures to treatpatients who might not otherwise be eligible for surgery,” said Dr.MarkCarlson, chief medical officer and vice president of global clinicalaffairs at St. Jude Medical.

Designed in collaboration with physicians, the self-expanding Porticovalve is designed to maintain hemodynamics similar to that of a naturalvalve, while also addressing issues from early generations oftranscatheter valves, such as paravalvular leak and the need for apermanent pacemaker as a result of the implant.

A prospective, multi-center, randomized, controlled clinical trial, thePORTICO trial is evaluating the safety and effectiveness of the PorticoTranscatheter Aortic Valve System in reducing the risk of death anddisabling stroke in patients with high or extreme surgical risk foropen-heart valve replacement surgery.

Patients at up to 40 U.S. sites will be randomized based on theappropriate access method, including transfemoral, transapical (valvedelivered via the left ventricle of the heart), direct aortic (throughthe ascending aorta), or subclavian (through an artery located below thecollar bone). All trial participants will undergo a TAVR procedurereceiving either a Portico valve or another commercially available TAVRvalve in the U.S. Data that are collected will be used to supportapproval of the Portico Transcatheter Aortic Valve Replacement System bythe U.S. Food and Drug Administration (FDA).

In addition to randomization, the PORTICO trial will also collectinformation in the form of a registry on patients with a degeneratedaortic surgical bioprosthetic valve (creating a valve-in-valveregistry.) These are patients in the trial who previously had valvereplacement surgery and now are having a Portico valve placed inside anexisting artificial valve without removing it.

The 23mm Portico transcatheter aortic heart valve and transfemoraldelivery system received a CE Mark in 2012 and the 25mm Portico valve received a CE Mark in 2013. CE Mark clinical trialsare currently underway for additional valve sizes and deliveryapproaches. The Portico transcatheter aortic heart valve system islimited to investigational use in the U.S., and the PORTICO trial isbeing conducted under an Investigational Device Exemption (IDE) from theFDA.

Aortic stenosis is the third most prevalent form of cardiovasculardisease in the Westernworld after hypertension and coronary artery disease. Considered apotentially life-threatening condition, the aortic heart valve becomescalcified and does not open properly. Roughly 25 percent of people 65and older, have aortic valve thickening and 3 percent age 75 and olderhave severestenosis.

For additional information about the Portico valve visit SJMPortico.comand for the PORTICO trial visit clinicaltrials.gov.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated totransforming the treatment of some of the world’s most expensive,epidemic diseases. The company does this by developing cost-effectivemedical technologies that save and improve lives of patients around theworld. Headquartered in St. Paul, Minn., St. Jude Medical has four majorclinical focus areas that include cardiac rhythm management, atrialfibrillation, cardiovascular and neuromodulation. For more information,please visit sjm.comor follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaningof the Private Securities Litigation Reform Act of 1995 that involverisks and uncertainties. Such forward-looking statements include theexpectations, plans and prospects for the Company, including potentialclinical successes, anticipated regulatory approvals and future productlaunches, and projected revenues, margins, earnings and market shares.The statements made by the Company are based upon management’s currentexpectations and are subject to certain risks and uncertainties thatcould cause actual results to differ materially from those described inthe forward-looking statements. These risks and uncertainties includemarket conditions and other factors beyond the Company’s control and therisk factors and other cautionary statements described in the Company’sfilings with the SEC, including those described in the Risk Factors andCautionary Statements sections of the Company’s Annual Report on Form10-K for the fiscal year ended December 28, 2013 and Quarterly Report onForm 10-Q for the fiscal quarter ended March 29, 2014. The Company doesnot intend to update these statements and undertakes no duty to anyperson to provide any such update under any circumstance.

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Source: St. Jude Medical, Inc.