Synovis ends enrollment in colorectal study, cites 'difference of opinion' with investigators

By Elaine Rigoli

Tampa, Fla., March 24 - Synovis Life Technologies, Inc. said it is ending the current colorectal market evaluation of circular PSD-Veritas used in colorectal surgeries after observing the difficulties of obtaining an objective analysis of clinical outcomes.

Synovis plans to collect marketing data through other means, according to a company news release.

The study calls for adverse events occurring in the evaluation to be reviewed by a Clinical Evaluation Committee (CEC), consisting of three of the study's investigators. Through March 17, there had been 85 procedures in the study: 42 in the buttress group of the study and 43 in the control group, where no buttress was used.

Eleven adverse events occurred: four in the control group, including two deaths, and seven in the buttress group, in which there were no deaths. None of the events were considered unusual, given the nature of the surgeries, the release said.

The committee reviewed five of the seven events in the buttress group and determined that four of the reviewed events were not related to the buttress and the fifth was unlikely to be related to the buttress.

These surgeries involve complex cases with many variables having the potential to result in complications, the release said.

Synovis has determined that the presence of so many variables will leave the outcomes open to the opinion of an individual surgeon, as opposed to objective fact, the release said.

Synovis said this fact diminishes the value of the study relative to its estimated completed cost.

"As the study has unfolded, we have observed that the subjective nature of the professional judgments required of the CEC in the review process has resulted in differences of opinion among the investigators," Synovis president and chief executive officer Karen Gilles Larson said in the release.

"Having seen this, and understanding how this will reduce the value of the study's results in the marketplace, we believe it is in the best interests of our shareholders to forego additional investment in this study. We estimate that our expenses for this study through March of this fiscal year are approximately $250,000. If the study had run to its end-point through 2007, our estimates were that it would have cost $3.5 million. We will follow those patients already enrolled to the pre-determined end-point of the study," she added.

The company believes there is a good opportunity for circular PSD-Veritas in colorectal surgery and will seek to identify a more objective means of demonstrating its value to potential users, the release said.

Synovis, based in St. Paul, Minn., develops medical devices for the surgical and interventional treatment of disease.

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