Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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)

You may also be interested in...

Synapse Biomedical Debuts Diaphragm Pacer, HDE-Cleared To Aid Breathing

Synapse Biomedical will pursue expanded approval of its diaphragm pacing system to facilitate breathing in patients with Lou Gehrig's disease after gaining a humanitarian device exemption June 17 for use by ventilator-dependent spinal cord injury patients, according to the company

US FDA Complete Response Letter Rates Vary With Sponsor Size

Pink Sheet infographic illustrates benefits of big pharma’s resources and experience.

Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?

Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts