“Hey Jude, don’t let me down. You have found her, now go and get her. Remember to let her into your heart, Then you can start to make it better.” – The Beatles (Hey Jude).
St. Jude said its “Genesis” neurostimulation system, an implant for treating migraine headaches, didn’t slash pain levels by the threshold requested by U.S. regulators, though patients receiving the therapy reported significant benefits. The Genesis system is a stopwatch-sized device that is implanted in the upper chest or abdomen, with lead wires extending to the occipital nerves at the back of the head. The system is designed to deliver constant electrical energy to these nerves, which is thought to have a role in how patients experience pain from migraine headaches.
Results from St. Jude’s recent study of the device look promising: After one year of using Genesis, 66% of patients reported excellent or good relief with a 40% reduction in pain. Unfortunately, however, the study did not reach the 50% threshold, the standard set by researchers and government regulators as the so-called “primary endpoint,” which would have demonstrated the device’s effectiveness. “In the specific measure that was the primary endpoint, we fell short,” noted Chris Chavez, president of St. Jude Medical’s neurostimulation business. “But on balance, we think the evidence is strong for safety and effectiveness – so much so that we’ve decided to file for (European) approval.”
Indeed, St. Jude Medical said it hopes to launch the product in Europe this year and will talk with the Food and Drug Administration about whether the study results can be used to support an approval for the device in the U.S. “I would hope the FDA would look at the data and say ‘yes, this device works and the endpoints are wrong,’” commented Dr. Stephen Silberstein, director of the Jefferson Headache Center and the study’s principal investigator. The study did show a 40% reduction in pain, he added, calling the improvement “clinically significant.”
Note, Boston Scientific (BSX) is currently obtaining data on the safety and effectiveness of a similar device for migraine patients called PRISM.
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