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History of MED Institute Bill Cook, founder of the Cook Group, and Dr. Neal Fearnot discussed the possibility of starting a company to serve as development support for the Cook Group companies in 1982. Incorporation papers were signed for MED Institute on May 26, 1983. The following is a brief history of MED's involvement with COOK accomplishments: 1983 Office space was leased from the Purdue Research Foundation. Work began in September on the first project: developing the technology produced by Dr. Fearnot at Purdue University into an improved prototype for a temperature-based exercise responsive pacemaker with Cook Pacemaker Corporation (now known as Cook Vascular.) 1984 Engineering projects included a perfusion calculator, a COOK cardiac output measurement instrument, and continued work on the temperature-controlled pacemaker. The in-vivo studies performed at Purdue University were continued and expanded with clinical temperature data. 1985 Work began on a hyperthermia project to treat brain cancer, and MED leased additional space to accommodate the expanding business. 1986 The capability for supporting regulatory submissions was started to accommodate the needs of the pacemaker and hyperthermia projects. 1987 Clinical studies techniques were developed for the hyperthermia device. 1989 Drug-eluting stent research was started at Purdue as a COOK Incorporated technology development project. 1990 Land was purchased in the Purdue Research Park, and construction of a new facility began. 1991 Clinical data were analyzed and PMA was written that culminated in FDA approval to market the first U.S. coronary stent in June 1993. 1991 Formal software procedures were developed to meet FDA expectations. During the summer, MED Institute moved from its original 2800 square foot office to the current location. The new building was about 10,000 square feet. 1993 Formal procedures for conducting Good Laboratory Practice (GLP) studies were developed. 1995 Off-Site studies conducted at Purdue were performed with GLP compliance. 1996 Custom software was developed for enrollment and validation for COOK clinical data. Laboratory, testing facilities and capabilities were greatly increased to enhance the development and testing of drug-eluting stents. 1996 MED Institute conducted the largest coronary device trial in the United States, enrolling 2300 patients. This led to the approval of the 3rd coronary stent in the United States in 1997. 1997 Histology processing was established to keep up with the pace of animal studies required for regulatory submissions worldwide. 1998 FDA clearance for SIS as a wound dressing was obtained for Cook Biotech Inc. 1998 A Quality System was developed, culminating in ISO 9001 Certification. 1999 An 18,000 square foot addition was constructed, increasing lab, office, and meeting space to house the additional personnel and equipment needed to meet the increasing needs of COOK companies required for regulatory submissions worldwide. 2000 MED initiated clinical trials of paclitaxel-coated coronary stents in Europe and Asia. 2003 MED supported nonclinical testing, clinical trial administration, monitoring, data analysis, PMA submission, and presentation to an FDA advisory panel that led to permission for COOK to market the Zenith® AAA Endovascular Graft. |
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