Devices & Diagnostics

St. Jude Medical’s Portico TAVI heart valve wins CE Mark

St. Jude Medical (NYSE:STJ) announced Monday that it has received CE Mark for its Portico transcatheter aortic valve system for patients who are deemed too sick to undergo open heart surgery to replace diseased heart valves. The medical device manufacturer has received clearance for the 23 mm Portico TAVI valve and St. Jude Medical describes […]

St. Jude Medical (NYSE:STJ) announced Monday that it has received CE Mark for its Portico transcatheter aortic valve system for patients who are deemed too sick to undergo open heart surgery to replace diseased heart valves.

The medical device manufacturer has received clearance for the 23 mm Portico TAVI valve and St. Jude Medical describes the Portico system as the “only approved transcatheter 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 it is released from the delivery system.”

The valve was designed with the help of physicians to address one of the more common problems with first generation TAVI valves – paravalvular leak, a post-operative complication where blood flows through a channel between the implanted heart valve and the cardiac tissue because the prosthetic valve has not been sealed properly.

“The ability to completely resheath, reposition or retrieve the Portico valve is an important improvement over previous-generation transcatheter valves,” said Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K, in St. Jude’s news release. “This is particularly helpful in ensuring accurate placement of the valve and minimizing complications for this high risk population.”

A study to obtain CE Mark for a 25 mm TAVI valve will be begun by the end of the year, but the ramp up of St. Jude’s TAVI program may not live up to expectations of at least one analyst.

In late October, Morgan Stanley analyst David Lewis downgraded the company’s stock, citing among his reasons the slow progress of St. Jude’s transcatheter aortic valve implantation program.

“Portico launch will ramp slowly next year due to a limited range of initial sizes and may stall as Medtronic launches its second-gen device,” he wrote in his Oct. 29 research note.

An earlier version of the story incorrectly stated that St. Jude Medical is expecting CE Mark for a 25mm TAVI valve by the end of the year. A study to gain that clearance will be launched at the end of the year.