Minnesota medtech maker St. Jude Medical (NYSE:STJ) launched a U.S. study of its Portico catheter-based aortic valve, enrolling the 1st patients in pursuit of FDA approval for the implant.
Surgeons on opposite coasts performed a pair of procedures, treating patients in Los Angeles and New York City.
St. Jude says its Portico transcatheter aortic valve implantation system is the 1st to be repositionable until full deployment, allowing clinicians to ensure optimal placement.
"We have received positive feedback on the advanced features of the Portico valve from the experienced physicians who have used it," St. Jude chief medical officer and global clinical affairs vice president Dr. Mark Carlson said in prepared remarks. "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."
The Portico valve has been on the European market since 2012 and won expanded approval last year for a larger model. The new U.S. study is designed to gather data in support of approval from the FDA.
St. Jude has some catching up to do to meet competing TAVI makers Edwards Lifesciences (NYSE:EW) and hometown rival Medtronic (NYSE:MDT). Edwards’ Sapien system has been available in the U.S. since winning approval in 2011 and Medtronic’s CoreValve made it to market earlier this year.