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Morris Innovative Research |
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907 West Second Street
Bloomington, IN 47403
phone:
fax:
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Private |
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| www.morrisinnovative.com
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| Summary Description |
| Developer of products facilitating natural vascular closure and opening vessels. |
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| Management |
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| Description |
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The FISH closure device was studied in a randomized controlled multi-center clinical trial which, thus far, has enrolled 292 patients. The study was conducted at The Cleveland Clinic (Cleveland, OH), St. Thomas Hospital (Nashville, TN), St. Vincent’s Indianapolis Hospital (Indianapolis, IN), Methodist Hospital (Indianapolis, IN), University of Kentucky Hospital (Lexington, KY), Bloomington Hospital (Bloomington, IN), and Penn State Hershey Medical Center (Hershey, PA). This U.S-based trial compared the FISH device to manual compression. Manual compression is the standard against which all vascular closure devices are compared. The study included patients undergoing diagnostic or therapeutic coronary or peripheral procedures performed via the common femoral artery. The procedures were done with an 8 French or smaller sheath size. There were a total of 40 investigators who enrolled patients for the study. Each investigator had the opportunity to enroll up to two roll-in patients, which were non-randomized patients. There were a total of 26 roll-in patients in the study for 40 investigators. This study included six U.S. sites and enrolled patients between January 2004 and June 2006. The patients agreed to return for a follow-up evaluation at 30 days. |
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| Products / Services |
FISH™ Device
The Femoral Introducer Sheath and Hemostasis Device.
Morris Innovative's revolutionary approach to vascular closure.
Leader Guidewires™
Simple straight forward design with
impeccable quality and construction.
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| Strategy |
The Femoral Introducer Sheath and Hemostasis Device is superior to manual compression in both time to hemostasis, time to ambulation, and time to eligible discharge. Based on results from in vitro animal studies and human clinical studies, as well as the ongoing FISH clinical trial, there is valid scientific evidence that the FISH device is safe and effective.
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