dimarts, 6 d’octubre del 2015

TAVI: Study prompts FDA notice on blood clot risk

Transcatheter aortic valve implantA small study published yesterday in the New England Journal of Medicine, finding reduced leaflet mobility in some replacement heart valves, prompted the FDA to caution doctors about the risk of blood clots on the devices.

The finding is notable because it involves both transcatheter aortic heart implants and surgical aortic valve implants, which have been in use for roughly 30 years. The researchers looked at data from St. Jude Medical‘s (NYSE:STJ) investigational device exemption trial for its Portico TAVI device and a pair of registry studies following patients treated with TAVI and SAVI devices.

Examining CT scans from all 3 trials, they found reduced leaflet mobility in 22 of 55 (40%) patients in the Portico trial and 17 of 132 patients (13%) in the registries. In the Portico IDE trial, all of the 11 patients treated with the anti-coagulation drug warfarin showed restored leaflet motion, according to the NEJM study.

The FDA said it still believes that the valves “remain reasonably safe and effective when used according to their approved indications,” but said that follow-up CT scans or transesophageal echocardiographies may be warranted.

“These reports have raised important questions about bioprosthetic aortic valves. However, limited available data do not allow us to fully characterize the causes, incidence, and short and long-term risks of reduced valve leaflet motion, or to recommend appropriate treatment. The FDA is working with the American College of Cardiology, the Society of Thoracic Surgeons, and the device manufacturers to design clinical studies to fully evaluate reduced valve leaflet motion for all types of bioprosthetic aortic valves,” the federal safety watchdog said.

The blood clot phenomenon in TAVI devices is not new, having prompted both St. Jude and Edwards Lifesciences (NYSE:EW) to temporarily pause trials of their respective offerings, Portico and Fortis.

The post TAVI: Study prompts FDA notice on blood clot risk appeared first on MassDevice.



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