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SyntheMed completes enrollment for Repel-CV pivotal trial
By E. Janene Geiss
Philadelphia, Feb. 8 - SyntheMed, Inc. announced Wednesday the completion of patient enrollment for the multi-center pivotal clinical trial for Repel-CV Adhesion Barrier.
The clinical trial, which began about two years ago, is being conducted at about 15 pediatric cardiac surgery centers in compliance with a surgical protocol approved by the Food and Drug Administration.
"We are very pleased to have achieved this milestone and now look forward to completing the pivotal trial in mid-2006. Assuming a favorable outcome, the trial results will be submitted to the FDA as a basis for securing approval to market Repel-CV in the U.S. for use in all cardiac surgical procedures," Eli Pines, chief scientific officer, said in the release.
The company also said it is conducting a multi-center clinical study for Repel-CV involving several leading cardiac surgery centers in Europe.
This open label study is distinct from the U.S. pivotal trial and is intended to support the anticipated market launch of Repel-CV in Europe and other international markets beginning in mid-2006, officials said.
Post-operative adhesion formation is a prevalent and serious complication experienced in the about 1 million open heart surgical procedures performed worldwide on an annual basis.
Repel-CV could become the first adhesion barrier approved by the FDA for use in cardiac surgery, which could represent a $250 million annual worldwide market opportunity, officials said.
SyntheMed is an Oceanport, N.J., biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products.
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