Why St. Jude Medical Might Have a Trancatheter Valve Problem

When it comes to transcatheter aortic valve replacement (TAVR) technology, St. Jude is less upbeat than Medtronic, Edwards, or Boston Scientific. While those companies proudly announced positive data from their TAVR products at the Transcatheter Cardiovascular Therapeutics event in Washington D.C., St. Jude declared that it was temporarily halting implants of its Portico transcatheter aortic valve replacement (TAVR) devices after it spotted a problem with the devices. 

"St. Jude Medical has paused implanting all TAVR devices worldwide to allow the company time to evaluate recent cases of reduced valve leaflet mobility that were reported from a small number of 4D CT scans performed approximately 30 days after implant in the U.S. IDE study," St. Jude spokesperson Candace Steele Flippin told Qmed.

"Because patient safety is our highest priority, we made the decision to stop implanting Portico devices worldwide until we complete our comprehensive analysis."

The 4D CT scans that led St. Jude Medical to "pause" implantations of its Portico transcatheter aortic valve replacement (TAVR) devices (an example of which is shown here) worldwide this week were not part of the company's U.S. study, according to a St. Jude spokesperson.

The 4D scan, which study cardiac motion, is "very new technology" that was not part of the IDE study protocol, says Candace Steele Flippin.

"That's not St. Jude Medical technology," she added.

A 4D CT scan allows for less distortion of images by patient breathing, according to a presentation by Steve B. Jiang of the University of California at San Diego.

Steele Flippin declined to elaborate on who performed the 4D CT scans, but said she was told such scans are not used in Europe, where St. Jude has been approved to sell Portico devices since November 2012. The U.S. IDE study includes Portico valves in the 23, 25, 27, and 29-mm sizes.

St. Jude announced the U.S. IDE trial implants of the Portico device in May, calling the Portico "the first aortic heart valve that is repositionable until fully deployed."

Last Saturday, a St. Jude investigator presented the company's 12-month EU data at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C., Steele Flippin said."The gradients and valve areas are all consistent with what we've seen in the literature and what we would expect," she added.

To date, the worldwide TAVR adverse event rates remain low and are consistent with event rates cited in the literature, she added.

St. Jude's temporary halt to TAVR implants comes as major medtech companies jockey for global TAVR market share. In May, Medtronic agreed to a $1 billion settlement of a patent infringement suit by TAVR market leader Edwards Lifesciences. The litigation would have stalled sales of Medtronic's CoreValue System, which the FDA approved January 17.

Medtronic, Edwards, and Boston Scientific also touted their TAVR devices at the TCT conference.

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Nancy Crotti is a contributor to Qmed and MPMN.

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