CardioKinetix commences Parachute Ventricular Partitioning Device clinical trial in IHF

CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that it has begun enrollment in PARACHUTE III, a post-market safety surveillance trial, in Germany with the CE Marked Parachute™ Ventricular Partitioning Device.    

After a heart attack, many heart failure patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

The first implants with CE Marked Parachute devices were done in Heidelberg, Germany by Stefan Hardt, M.D., Department of Cardiology, Heidelberg University Clinic as part of the PARACHUTE III trial, which is designed to evaluate the long-term safety of the Parachute implant in a real-world setting in up to 100 patients with ischemic heart failure at up to 20 centers in Europe. Professor Hardt reported that all patients were treated successfully and discharged without procedure-related complications. A successful case was also performed by Heyder Omran, M.D., Ph.D., Department of Cardiology and internal Medicine, St. Marien-Hospital Abt. Innere Medizin in Bonn, Germany.

"The Parachute implant system represents an important advancement in treatment options for patients with ischemic heart failure," said Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas Hospital in London, England, and the principle investigator for the PARACHUTE III study. "These first procedures in the PARACHUTE III trial represent the beginning of the largest clinical data evaluation for this new therapy to date. I am optimistic that the patients treated with the Parachute implant will experience positive results similar to those in prior trials of the device most recently reported during the 2012 EuroPCR meeting."

CardioKinetix plans to continue expanding its post-marketing trial effort in Europe by adding hospitals in the UK, Spain, Italy, Belgium, Germany, and the Netherlands in coming months. The PARACHUTE III clinical trial will enable physicians in the European Union to increase their experience with the technology while continuing to develop the therapy.