Firm submits PMA application to treat medically refractory partial onset epilepsy with its RNS System implant. The device is unique in that it is designed to detect abnormal electrical activity in the brain and then deliver small amounts of electrical stimulation to suppress a seizure before it occurs - referred to as responsive neurostimulation. This "differs from the continuous or intermittent stimulation provided by commercially available neurostimulation systems," the company explains. The privately held firm's 191-patient randomized pivotal U.S. trial showed that the device reduced seizure frequency by 37.9% after three months compared to 17.3% for sham treatment - a statistically significant difference, according to NeuroPace. While Cyberonics' VNS Therapy vagus nerve stimulation implant is currently the only FDA-approved implant for drug refractory epilepsy, Medtronic expects to gain U.S. approval for its DBS deep brain stimulation implant for epilepsy later this year following an FDA panel endorsement in March (1"The Gray Sheet" March 15, 2010)
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The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.
