Synapse Biomedical gets warning letter for IDE studies
This article was originally published in The Gray Sheet
Executive Summary
Firm is cited in a June 20 FDA 1warning letter for failing to perform some sponsor obligations in pivotal and pilot investigational device studies. The letter comes on the heels of Synapse's June 17 FDA approval for its NeuRx DPS diaphragm pacing system for certain spinal cord injury patients via humanitarian device exemption (HDE). NeuRx DPS stimulates the diaphragm and allows patients to breathe for at least four hours a day without a mechanical ventilator. According to the letter, based on an inspection conducted Feb. 25-March 18, Synapse expanded one study to four additional clinical sites without prior FDA approval. The firm also failed to adequately monitor the studies and obtain signed agreements from each investigator with full financial disclosure information. Synapse also shipped replacement parts for the device directly to trial subjects. CEO Anthony Ignagni says the issues are not related to product quality or performance and do not preclude the firm from shipping its products for use in spinal cord injury patients or in clinical trials of patients with amyotrophic lateral sclerosis (2"The Gray Sheet" June 23, 2008, p. 21)
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