In October, a clinical trial by St. Jude Medical, a medical device manufacturer based in Little Canada, Minnesota, was reported as a failure. The device tested in the trial, the Amplatzer PFO Occluder, was being tested for its efficacy in blocking holes in the heart. By blocking holes in the heart, the device was expected to reduce the risk of stroke. However, the results of the study indicated that the device failed to live up to its expectations.
St. Jude Medical recently experienced other failures too. After the results of the above study were made public, St. Jude Medical’s stocks experienced a moderate decrease. In addition, recent clinical trials showed that Amplatzer heart implants, a device intended to reduce cryptogenic stroke, failed to live up to expectations.
Gore & Associates, a manufacturing firm that works with St. Jude Medical, defended the results of both trials. While these trials failed to meet the defined positive endpoints, they did show the company that future trials should include more rigorous guidelines for registering test subjects.
In a prepared statement, researchers at Gore & Associates said, "The response to these findings has, thus far, been mixed.” The statement continued, " Those in favor of PFO closure have emphasized that these findings, together with the secondary endpoint analyses, reaffirm that carefully selected patients with a history of cryptogenic stroke and PFO may, indeed, benefit in stroke risk reduction from device closure over medical management alone."
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