A new medical device is facing a potential hurdle following a Food and Drug Administration review that called into question the safety of the item.
The product in question is the Sapien heart valve manufactured by Edwards Lifesciences Corporation. The Sapien is intended to be used as an alternative to surgery in order to correct a condition known as aortic senosis. Aortic senosis is what occurs when a restricted valve impedes the blood’s pathway to the aorta. Currently, the Sapien is approved for use in patients who are unable to get open-heart surgery, but its makers are seeking approval for patients who are eligible for surgery yet face a heightened risk of an adverse condition.
The FDA worried that the trials that were conducted may have been biased at the categorization level. Eligibility seemed to vary depending on the location that each trial was held at, and certain researchers may have stood to gain financially from the approval of the device. Those researchers could be responsible for bringing in 30% of all patients enrolled. In addition, an inordinately large number of people either died or withdrew prior to the implantation of the device.
There also appears to be a heightened risk of stroke in the first 30 days, or the first year in cases where patients opt for an arm incision rather than a leg incision. If the study is eventually approved, the FDA has recommended a post-approval study to monitor patients.