The PARACHUTE^TM Feasibility Study

PARACHUTE^TM IDE Feasibility Trial to Evaluate the VPD device

The PARACHUTE^TM IDE Trial is a prospective, multi-center, feasibility trial to assess the safety and feasibility of the CardioKinetix PARACHUTE^TM Implant and Delivery System in the partitioning of the Left Ventricle in patients with heart failure due to ischemic heart disease. The study will collect initial clinical information to frame the PARACHUTE^TM Pivotal Trial design.

The PARACHUTE^TM Pivotal Trial

The company plans a United States Pivotal trial to determine the efficacy and clinical benefits of the PARACHUTE^TM device in ischemic heart failure patients.

European Experience

Preliminary safety has been established for the PARACHUTE^TM Ventricular Partitioning Device in 13 patients in the European PARACHUTE^TM trial who have been followed up for more than two years. The data exhibits significant functional and hemodynamic changes from baseline including sustained drop in NYHA Class, increase in EF and changes in LV volumes. PARACHUTE^TM is currently undergoing investigational clinical use in 20 patients from 8 U.S. centers, in the US PARACHUTE^TM IDE feasibility study.

Clinicians interested in participating in the U.S. study should contact Gerard Champsaur, MD, Chief Medical Officer, CardioKinetix, Inc., Gerard@CardioKinetix.com, Phone (650) 364-7016, extension 421.

US Clinical Sites

• Ohio State University, Columbus Ohio
• Texas Heart Institute, Houston Texas
• Northwestern University, Chicago, IL
• Washington Hospital Center, Washington, DC
• Gagnon Cardiovascular Institute, Morristown, NJ
• Geisinger Clinic, Danville, PA
• Mission Hospitals, Asheville, NC
• Oklahoma Heart Hospital, Oklahoma City, OK

Publications

• "Left Ventricular Apex Occluder; Description of a Ventricular Partitioning Device;" EuroInterv.2006;2:125-0127; H. Sharkey, S. Nikolic, PhD, A. Khairkhahan, M. Dae, MD.
• "Percutaneous Ventricular Restoration in a Chronic Heart Failure Patient;" EuroInterv.2006;2:128-131; M. Skowasch; G. Robertson; N. Wunderlich, S. Nikolic, A. Khairkhahan, H. Sievert.
• "Percutaneous Implantation of an Intraventricular Device for the Treatment of Heart Failure: Experimental Results and Proof of Concept;" Journal of Cardiac Failure, 2009;Vol.15 No.9:790-797; S. Nikolic, PhD, FACC, A. Khairkhahan, MS, M. Ryu, DVM, G. Champsaur, MD, FACC, E. Breznock, PhD, DVM, M.Dae, MD.
• "First-in-Man Implantation of Left Ventricular Partitioning Device in a Patient With Chronic Heart Failure: Twelve-Month Follow-up;" Journal of Cardiac Failure, 2007;Vol.13 No.6:517-520; P. Otasevic, MD, D. Sagic, MD, PhD, Z. Antonic, MD, S. Nikolic, PhD, A. Khairakhan, MSC, B. Radovancevic, MD, Sinisa Gradinac, MD, PhD.