First U.S. Implants in St. Jude Portico Transcatheter Aortic Heart Valve IDE Study

The big news in transcatheter aortic valve development is that St. Jude Medical, Inc. has seen the first patient implants 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, claimed by St. Jude to be the first aortic heart valve that is repositionable until fully deployed.

Background

The 23 mm Portico transcatheter aortic heart valve and transfemoral delivery system gained European CE Mark approval in 2012 and the 25 mm Portico valve received a CE Mark in 2013. For now though, the system is limited to investigational use in the U.S., the PORTICO trial being conducted under an Investigational Device Exemption (IDE) from the FDA.

The PORTICO trial is evaluating the Portico valve and delivery system in patients with symptomatic severe aortic stenosis, enrolling patients who are considered to have a high or an extreme surgical risk for open-heart surgery. These are the same patients for whom Edwards Sapien and Medtronic’s CoreValve are currently indicated.

A prospective, multi-center, randomized, controlled clinical trial, PORTICO is evaluating the safety and effectiveness of the Portico Transcatheter Aortic Valve System in reducing the risk of death and disabling stroke in these patients. Patients at up to 40 U.S. sites will be randomized based on the appropriate access method, including transfemoral, transapical, direct aortic, or subclavian. 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 FDA approval of the Portico Transcatheter Aortic Valve Replacement System.

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.

 

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. Wen Cheng , 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 of Dr. Gregory P. Fontana , cardiac surgeon and chairman of the department of cardiothoracic surgery and Dr. Carlos Ruiz , an interventional cardiologist at Lenox Hill Hospital in New York City. Drs. Fontana and Makkar serve as co-principal investigators for the PORTICO trial.

Investigator comments

“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.

Company comments

“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. Mark Carlson , chief medical officer and vice president of global clinical affairs at St. Jude Medical.

Source: St. Jude Medical, Inc., Business Wire

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