heart devices -- with an accessory pathway

these 2 headlines came across my desk today.  related?? turns out that medical devices much less regulated than drugs.  Geoff
Big Changes to Heart Devices OK’d Without New Data   
Many of the high-risk implantable cardiac devices in use today were approved through a supplement pathway that does not require new clinical data on the safety and effectiveness of changes made to the products since their original approval, a review of an agency database showed. Read more
By Larry Husten
Pediatric cardiac surgeons at Boston Children's Hospital are warning about a potentially fatal problem in children and young adults who received a bioprosthetic cardiac valve.
The surgeons initially became concerned when a young, asymptomatic patient died suddenly after her valve underwent rapid calcification, only 7 months after a routine follow-up echocardiogram found no signs of blockage.
In recent years, surgeons started using the Sorin Mitroflow valve, which is made from bovine tissue, in the aortic position. Following the death last year of the patient, who received the Mitroflow in 2011, doctors at BCH began an intense surveillance of all 18 patients at their institution who had received the Mitroflow valve in the aortic position. They found four additional cases of rapid calcification (three patients had their valves replaced with a mechanical valve; the other is being watched closely).

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