The Company has initiated three phases of evaluation of the Crux IVCF. Two of the studies are being conducted outside of the United States. These studies are being conducted under strict compliance with both local country and international requirements. The design and results of the study will be reviewed by its Scientific Advisory Board. An experienced independent Clinical Research Organization is coordinating both U.S. and international evaluations.
International Studies:
The Company has completed its First-in-Man studies with Dr. Adrian Ebner, a noted physician and clinical investigator. Dr.Ebner practices at the Hospital Privat Francais in Asuncion, Paraguay. Crux sponsored a study of its filter in 10 consecutive patients, starting in December of 2006. All implants were successfully placed with no observations of migration, deployment difficulties or IVC perforation. In 4 cases to date, device retrieval was easily performed in under 5 minutes per case.
A second study, RETRIEVE II, is anticipated to begin in Q4 of 2007, in Europe. The Company, working with noted interventional experts in the United Kingdom and Austria, plan to implant a minimum of 25 patients with the Crux IVC filter. Data from this study will support the Company’s efforts to gain certification for a CE Mark.
Domestic Study:
Crux Biomedical RETRIEVE I Clinical Study
Crux has received conditional approval by the U.S. FDA in September 2007, to begin its pivotal clinical study in the United States. This clinical evaluation is an open-label, non-randomized, prospective, multicenter study. The design of the study has been reviewed by both the FDA and external experts to the Company. The primary objective of the RETRIEVE study is to describe the clinical utility of the Crux IVC Filter by absence of a PE (pulmonary embolism). The secondary objective is to evaluate the retrieval success of the device (as indicated). The RETRIEVE study will be conducted initially by Investigators at 12 highly esteemed hospitals where IVC filters are routinely implanted. The following sites will participate in the RETRIEVE Study:
| Hospital |
Location |
Clinical Investigator |
| Atlanta Medical Center |
Atlanta, Georgia |
David Rosenthal, M.D. |
| Barnes Jewish Hospital |
St. Louis, Missouri |
Luis Sanchez, M.D. |
| Cleveland Clinic |
Cleveland, Ohio |
Mark Sands, M.D. |
| Harbor UCLA Hospital |
Torrance, California |
Rod White, M.D. |
| Hartford Hospital |
Hartford, Connecticut |
Mike Hallisey, M.D. |
| Inova Fairfax Hospital |
Fairfax, Virginia |
Alain Drooz, M.D. |
| Jobst Vascular |
Toledo, Ohio |
Tony Comerota, M.D. |
| St. Francis Hospital |
Teoria, Illinois |
Bob Smouse, M.D. |
| St. Joseph Hospital |
Orange, California |
Kurt Openshaw, M.D. |
| U.C. Davis Medical Center |
Sacramento, California |
John Laird, M.D. |
| University of Michigan |
Ann Arbor, Michigan |
Kyung Cho, M.D. |
| University of North Carolina |
Chapel Hill, North Carolina |
Robert Mendes, M.D. |
Prinicipal Investigator for the study is David Rosenthal, M.D., Chief of Vascular
Surgery, Atlanta Medical Center.