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Título: CardioKinetix Releases One-Year Clinical Data From European Trial Showing Consistent, Compelling Positive Results for Patients Treated With Minimally Invasive Device for Heart Failure
Fecha: 16-09-2014
MENLO PARK, Calif., Sep 16, 2014 (BUSINESS WIRE) -- CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a pooled analysis study of the first-of-its-kind catheter-based Parachute® Ventricular Partitioning Device. Twelve-month clinical data from PARACHUTE III, a study of 100 post-market European patients with ischemic heart failure treated consecutively between 2011 and 2013, were presented at the 2014 TCT Conference in Washington, D.C., by Ulrich Schäfer, M.D., cardiology director of the Structural Heart Division at the Heart Center at the University Medical Center Hamburg-Eppendorf, and at the 2014 HFSA Conference in Las Vegas, Nev., by William Abraham, M.D., professor of internal medicine and director of the Division of Cardiovascular Medicine at Ohio State University Medical Center.
“The results of this European post-market study continue to substantiate the safety profile and effectiveness of the Parachute as a viable, minimally invasive device technology for patients with heart failure,” said Dr. Abraham. “The very compelling data from these 100 European patients demonstrates the clear promise of this breakthrough technology and is exciting news for the more than 50 active hospitals in the U.S. randomized trial, PARACHUTE IV, which is currently enrolling patients.”
Parachute had a very high procedural success rate of 97 percent (97/100). The twelve-month highlights from the data include:
- Primary safety endpoint yielded a low 7% rate of device- or procedure-related MACCE
- Sustained reduction of left ventricle volumes (p < 0.0001) resulting in significant improvements in systolic function and a significant reduction in left atrial volume (p < 0.05) reflected improved diastolic function
- NYHA functional class improved or maintained in 80 percent of patients
- Six-minute walk distance improved at follow-up (p < 0.01), with 46 percent of patients walking an additional 20 meters or more
- Rates of death and the combined endpoint of death and repeat hospitalization for heart failure were 9.5 percent and 26.0 percent, respectively
“The results of this trial add excitement about the Parachute treatment, which offers an option to heart failure patients with a very poor prognosis the promise for improved quality of life and reduced rates of mortality and heart failure hospitalization,” said Dr. Schäfer.
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged and who suffer from heart failure are limited, with a significant number currently receiving an implantable cardioverter-defibrillator (ICD) and approximately one-third receiving a cardiac resynchronization therapy device (CRT-D) device. 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.
About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.
About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle 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. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.
The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.
About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Archer Ventures, Panorama Capital, H&Q Healthcare InvestorsHQH, -1.81% and H&Q Life Sciences Investors HQL, -1.52% For more information please visit www.cardiokinetix.com.

SOURCE: CardioKinetix Inc.
CardioKinetix
Barry Templin, 650-364-7016
btemplin@cardiokinetix.com
Copyright Business Wire 2014
Fuente: endovascular.es

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