Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the enrollment of the first patients in PARACHUTE China, a multi-center trial to evaluate the minimally invasive Parachute® Ventricular Partitioning Device for the treatment of heart failure.
The first ten patients were treated with the Parachute device in Beijing at Peking University and Fu Wai Hospital, and in Shanghai at Shanghai Tenth People’s Hospital.
Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences, principal investigator of the trial, said, “I am thrilled to be pioneering this exciting therapy in China with my colleagues, where there is a significant need for better treatments for heart failure. I am very proud that the first clinical trial cases were performed last week with such high interest by the study investigators, building upon the early, positive experience with the Parachute by leading cardiovascular centers in China.”
PARACHUTE China (clinicaltrials.gov/ NCT02240940) will enroll NYHA II to ambulatory IV ischemic heart failure patients to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.
“The initiation of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are proud of our efforts to bring the Parachute technology to market on three continents. The initiation of the China trial, along with the active enrollment in our PARACHUTE IV U.S. pivotal trial and the initial commercialization in key European centers under CE Mark, illustrate our commitment to developing the Parachute therapy for heart failure globally.”
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 many 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.
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 limited 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 Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.