Relievant lands FDA green light for clinical trial of Intracept back pain therapy

June 3, 2013 by Sony Salzman

Relievant Medsystems expands to 20 U.S. sites its SMART clinical trial for back pain therapy with the Intracept basivertebral nerve ablation.


Relievant Medsystems won FDA investigational device exemption for its Intracept back pain therapy, paving the way for the medical device company to continue its SMART pivotal clinical trial.

The Redwood City, Calif.-based company said it will expand the 200-patient randomized, controlled trial to 20 sites across the U.S., where it will evaluate the Intracept therapy in treatment of chronic low back pain.

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Relievant also made some changes to its senior management team. Av Edidin, former VP of science and technology at Medtronic (NYSE:MDT), will join the company as chief scientific officer and VP of R&D, according to a press release.

In addition Mike Welch will join Relievant as the VP of global market development. Welch has 25 years of experience at various medical device companies and has worked on product commercialization in over 40 countries, Relievant noted.