February 25, 2011
For immediate release
Contact: Gerry Ewing / 503-681-1654
A physician affiliated with Tuality Healthcare is taking part in a unique, ground-breaking stent study that could streamline the approval process involving the federal Food and Drug Administration and regulatory agencies in other countries. Daniel W. Isenbarger, M.D., a cardiovascular disease specialist, is helping conduct clinical trials on the safety and efficacy of Terumo Medical Corporation’s MISAGO peripheral artery stent.
The clinical trial has two unique aspects. The first is the stent itself. It is a self-expanding stent placed in the superficial femoral artery to help treat peripheral artery disease. The stent features unique flexibility characteristics. The femoral artery is the main blood supplier to the lower extremities. The stent helps improve blood flow through clogged or occluded vessels. The second unique aspect is the trial includes patients concurrently from both the United States and Japan.
“This kind of clinical trial has never been done before,” said Robert J. Murphy, president of the Storch-Murphy Group, the company handling communications for the trials. The uniqueness, he said, deals with the trial trying to gain regulatory approval in two countries simultaneously. The goal of the trial, which is part of a larger initiative called “Harmonization by Doing,” is to streamline the regulatory process for medical device approvals in different countries. Trials of this type, Murphy said, will result in lower costs and quicker approval and access to products.
The first use of the stent in a clinical trial was in September in Bradenton, Fla. Terumo hopes to expand the 350-patient figure by late this year. The results of the clinical trial likely won’t be available until some time in 2012, Murphy said.