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| St. Jude's Portico transcatheter aortic heart valve--Courtesy of St. Jude |
Due to concerns about reduced leaflet mobility, St. Jude Medical ($STJ) suffered a rare withdrawal of the CE mark of its Portico transaortic aortic valve replacement last year and had to suspend its U.S. clinical trial for FDA approval.
Mounting evidence that the abnormalities observed are not dangerous and common across both TAVRs and surgically inserted aortic valves that require open heart surgery (as opposed to the minimally invasive catheter-based procedure used to install TAVRS) led the CE mark to be reinstated in March.
Moreover, ClinicalTrials.gov shows that in March, the company once again began to recruit patients for a U.S. clinical trial to assess Portico patients for adverse events 30-days post implantation. The crucial, 5-year trial for coveted PMA approval from the FDA remains suspended, according to ClinicalTrials.gov.
But new data released from three studies at the annual EuroPCR conference in Paris should help St. Jude convince the FDA to resume that trial. The new information demonstrates that the abnormalities should not affect patient selection, procedural aspects, or post-procedural management, said Dr. Lars Søndergaard of Rigshospitalet, Denmark, who led one of the studies. "But the findings call for further studies," he cautioned in a release distributed by the conference.
St. Jude said the reduced leaflet mobility was noticed last year due to the use of advanced, 4D-CT scan imagining of the Portico during its U.S. clinical trial for FDA approval. And the experts at EuroPCR said that CT and echocardiographic imaging carried out in their studies found a range of abnormalities on a variety of TAVRs (sometimes called TAVIs) and conventional surgically implanted valves in 7-15% of patients. They include hypo-attenuated leaflet thickening, impaired leaflet motion and thin films in the thrombus.
So the issues detected by St. Jude due to the use of a new imaging modality are fairly common and apply to all sorts of cardiology implants. But the experts at EuroPCR stressed that the abnormalities are not associated with poor outcomes like stroke or valve failure. "It may be difficult to make advances, given the low level of risk that we have achieved already," said Dr. Franz-Josef Neumann, who authored one of the studies, in the release.
According to the release, Dr. Bernard Prendergast, the session's co-chair at EuroPCR said, "TAVI is an established lifesaving procedure with a wealth of high quality clinical evidence demonstrating its safety, durability and effectiveness. The reassuring data presented today indicate that there is no need for clinicians to adjust their practice in relation to patient selection, performance of the TAVI procedure, or follow up protocols, including post-procedural imaging and anti-thrombotic therapy."
- read the release